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Methodology: FISH
Clinical Significance:
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Translocations involving the MLL gene on chromosome 11q23 are noted in a subset of acute myeloid leukemias (AML) as well as acute lymphoblastic leukemias/lymphomas (ALL). In addition, treatment-related leukemias (5-10% of all leukemias), particularly those following treatment with anti-topoisomerase II or intercolating topoisomerase II inhibitors, but even those after more conventional alkylating or radiotherapy, often have translocations involving 11q23. The detection of translocations involving MLL is important in the diagnosis of patients with AML and ALL as they predict a poor overall prognosis. On the molecular level, the MLL gene on 11q23 is often juxtaposed with a variety of partner genes; the most frequent are listed below, although variant translocations involving other partners have been widely described in the literature. t(4;11)(q23;q23): Represents ~1/3 of cases and found mainly (95%) in precursor B acute lymphoblastic leukemia/lymphoma (CD19+ in 75%, CD10+ in 15%) as well as treatment-related ALL (5%). Children represent ~1/2 of cases with infants <1 year of age accounting for 1/3 of all cases. The gene involved on 4q21 is AF4, a transcription activator. t(6;11)(q27;q23): Represents 5% of cases, mostly in children and young adults, with a male predominance. The gene involved on 6q27 is AF6, which plays a role in signal transduction. t(9;11)(p23;q23): Represents 25% of cases and found mainly in AML, of which 70% show M5A morphology and 10% show M4, but 10% of cases represent ALL. In both de novo and therapy-related ALL, children represent half of cases (infants <1 year accounting for 15% of all cases). The gene involved in 9p22 is AF9, a transcription activator. t(10;11)(p12;q23): Represents 5% of cases, most of which present with M4 and M5 morphology. The gene involved on 10p12 is AF10, a transcription activator. t(11;19)(q23;p13.1): Represents 5% of cases, most of which present with AML M4 or M5 morphology. The gene involved on 19p13.3 is ELL, a transcription activator. t(11;19)(q23;p13.3): Represents 5% of cases. Acute lymphoblastic leukemia, biphenotypic acute leukemias and AML M4, M5. Mostly found in infants (roughly 50% of cases) and other children or young adults. The gene involved in 19p13.3 is ENL, a transcription activator. Probe type: Dual color breakapart
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Gliomas are the most common primary neoplasm of the central nervous system and can have strikingly different clinical behaviors and responses to therapy. Distinguishing between different subtypes is often less than perfect with significant inter-observer variability. Although attempts have been made to define clinical and histologic features that correlate with a favorable prognosis, none have been sufficiently reliable at predicting response to adjuvant chemotherapy. However, recent studies have shown that loss of 1p36 and 19q13 are associated with an oligodendroglial phenotype, favorable response to chemotherapy and overall prolonged survival. Fluorescence in-situ hybridization (FISH) studies provide a direct method for identifying loss of 1p36 and 19q13 in formalin-fixed, paraffin-embedded tissue sections. Loss of 1p36 and 19q13 is detected by assessing the ratio of 1p36 and 19q13 to their corresponding reference genes, 1q25 and 19p13, respectively, and by assessing the number of nuclei showing clear 1p36 and 19q13 deletion, according to guidelines defined by the International Society of Pediatric Oncology (ISPO). Probe type: Dual color enumeration (x2)
Organ: Brain/CNS
Disease State: Oligodendroglioma, Astrocytoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday, Tuesday, Wednesday, Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374x2. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ: Blood/Bone Marrow, Body Fluids
Disease State: Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH test detects deletion of 20q12, which is a chromosomal abnormality seen in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This FISH test is frequently utilized in the workup of MDS, which is a heterogeneous group of clonal myeloid stem cell disorders. Deletion of 20q12 as a sole abnormality is associated with a favorable prognosis. When seen with other chromosomal abnormalities, deletion 20q12 is associated with a poor prognosis. Probe type: Single Color Enumeration
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88367 or 88373. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH probe set detects deletion of 7q31 and monosomy 7, which are chromosomal abnormalities seen in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This FISH test is frequently utilized in the workup of MDS, which is a heterogeneous group of clonal myeloid stem cell disorders. Deletion of 7q31 is associated with an intermediate prognosis while monosomy 7 is associated with a poor prognosis. Probe type: Dual color enumeration
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ: Lung
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: ALK is a proto-oncogene highly expressed in a variety of tumor cells, and in particular in ~2-5% of non-small cell lung carcinomas owing to the presence of a chromosomal 2 EML4-ALK rearrangement. Cytoplasmic localization of ALK can be used to distinguish cancers containing the ALK translocation, with results between IHC and FISH highly concordant. Published data suggest that ALK rearrangement in NSCLC is a strong predictive marker for response to crizotinib. In our validation studies the cutoff for IHC positivity is ≥ 10%. (References: Kwak EL et al., N Engl J Med 363:1693-703, 2010; von Laffert M et al., J Thorac Oncol 9:1685-92, 2014).)
Organ: Lung
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies anaplastic large cell lymphoma and other T cell lymphomas. ALK is a protein overexpressed as a consequence of the (2;5) translocation that is found in anaplastic large cell lymphoma (ALCL). Expression of ALK is also seen in embryonal carcinomas and in a subset of inflammatory myofibroblastic tumors. Subcellular Localization:  Nuclear and cytoplasmic
Organ:
Disease State: Large Cell Undifferentiated Malignant Neoplams, Anaplastic Large Cell Lymphoma (Systemic or Cutaneous)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance: Two recurrent genetic abnormalities that occur in acute lymphoblastic leukemia (ALL) include the t(9;22) BCR/ABL and MLL gene rearrangements. “Ph+” ALL cases are more common in adults than children, but when present in either group portend a worse prognosis. Such cases that are Ph+ have been shown to be responsive to BCR/ABL targeted therapies such as imatinib. The t(v;11q23); MLL rearranged group refer to ALL cases which harbor an MLL translocation with one of a large group of partners. Such cases are best detected by an MLL breakapart FISH probe that detects any MLL rearrangement but does not distinguish between any specific type. MLL translocations may occur in utero and these types of ALL cases are the most common in infants less than 1 year of age. The presence of an MLL rearrangement generally portends a worse prognosis and higher risk of treatment failure.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL)
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: AMACR (alpha-methylacyl-CoA racemase, or p504s) is a highly sensitive positive marker of prostatic adenocarcinoma, and is generally negative on normal or atrophic prostatic glandular epithelium. Generally employed in the context of a panel of antibodies including those to p63 and high MW cytokeratins (antibody 34ßE12). Subcellular Localization: Granular cytoplasmic
Organ: Genitourinary, Prostate
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH panel is useful in the identification of a diverse set of specific chromosome alterations associated with various acute myelogenous leukemia (AML) subtypes that are part of the WHO Classification system for hematopoietic tumors. The t(8;21) is found in ~5% of AML and is associated with younger patient age and favorable response to chemotherapy with a high complete remission rate. The inv16/t(16;16)(p13;q22) group of leukemias occur in younger patients and this genetic alteration results in fusion of the CBFB gene to the MYH1 gene. This form of AML exhibits monocytic and granulocytic differentiation and a prominent eosinophilic component in the marrow. Monosomy 7/del 7q is found in ~40% of childhood myelodysplastic syndrome (MDS) and ~5% of pediatric AML and is associated with an adverse prognosis in the later. The 11q23 (MLL) rearranged cases of AML is associated with monocytic differentiation and a worse prognosis. Trisomy 8 is one of the most common numerical chromosomal alterations in AML, occurring in ~40% of cases and may portend a worse outcome.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374x6, 88367. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This panel detects the more commonly seen t(15;17) in acute promyelocytic leukemia (APL) as well as variant translocations detected by the RARA breakapart probe.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374x2. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The absence of expression of ATRX will be used to assist in the subclassification of gliomas. Studies in the published literature have demonsrtrated that loss of expression of ATRX (Alpha Thalassemia/Mental Retardation Syndrome X-Linked) in grade II/III astrocytomas as determined by immunohistochemistry corresponds to the presence of ATRX mutations. Most ATRX-loss gliomas also have IDH1 mutations, and show overexpression of p53 with the presence of corresponding p53 mutations. Gliomas with ATRX loss almost never show 1p/19q co-deletion. The vast majority of grade II/III gliomas can be categorized into 3 molecular subtypes based on status of IDH1 mutation, ATRX immunohistochemistry, and 1p/19q co-deletion. Subcellular Localization: nuclear
Organ: Brain/CNS
Disease State: Oligodendroglioma, Astrocytoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88312. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies adenovirus infected cells. This antibody reacts with all 41 serotypes of Adenovirus in formalin-fixed, paraffin embedded tissues. Subcellular Localization: Nuclear
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies intracytoplasmic globules, in the setting of alpha-1-antitrypsin deficiency. Subcellular Localization:  Cytoplasmic (globular)
Organ: Liver
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies yolk sac tumors that can be employed as part of a panel of markers of germ cell tumors. Not recommended in this setting as there are more sensitive and specific markers (e.g., glypican-3). Subcellular Localization: Cytoplasm
Organ: OB/GYN, Genitourinary, Liver
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a subset of amyloids, the protein nature of which is derived from AA protein. Subcellular Localization: Extracellular (amyloid deposits)
Organ:
Disease State: Amyloid Type Analysis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Amyloid beta localizes to the senile plaques characteristic of Altzheimer’s disease. Subcellular Localization: Extracellular (senile plaques)
Organ: Brain/CNS
Disease State: Amyloid Type Analysis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The 'plasma' or 'P' component of amyloid is derived from a normal circulating glycoprotein that is present in all amyloid subtypes. Subcellular Localization: Extracellular (amyloid deposits)
Organ:
Disease State: Amyloid Type Analysis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: This panel of antibodies can be employed to subclassify amyloid deposits based on their protein composition.
Organ:
Disease State: Amyloid Type Analysis
Turnaround Time:
Schedule:
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block or 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm, plus 2 unstained slides cut at 8-10µm or a Congo Red-stained slide
CPT Code(s): 88342; 88341x4; 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a subset of carcinomas, including those primary to the breast, salivary gland, and prostate. Subcellular Localization: Nuclear
Organ: Breast, Genitourinary, Prostate, Hormones
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Arginase-1 is a highly sensitive and specific marker of hepatocytes and hepatocellular carcinoma. Subcellular Localization: Nuclear and cytoplasmic
Organ: Liver
Disease State: Carcinomas of Unknown Primary, Hepatocellular Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88312. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube is designed to assess surface CD22 and nuclear TdT expression among presumed abnormal B-lymphoblastic cell populations. It includes antibodies to surface CD45, CD11b, CD22, CD19, CD34, CD33, CD79b, CD56, and HLA-DR, as well as a cytoplasmic TdT antibody.
Organ: Blood/Bone Marrow, Thymus (Mediastinal Mass)
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x10. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This panel is designed to detect residual B-ALL after therapy, and includes antibodies to CD45, kappa, lambda, CD5, CD34, CD20, CD10, CD19, and CD38.
Organ: Blood/Bone Marrow
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88184 x 1, 88185 x 8, 88188 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: BAP1 is a ubiquitin hydrolase and has been shown to enhance BRCA1-mediated cell growth suppression, and functions as a tumor suppressor gene. Loss of expression of BAP1 by immunohistochemistry correlates well with the presence of either BAP1 mutations or deletions at the DNA level. In a 2015 study, we have demonstrated that in the context of mesothelial lesions, BAP1 loss is 100% specific for mesothelioma, albeit with low (27%) sensitivity. However, when combined with p16 FISH a sensitivity of 58% for mesothelioma can be attained (Sheffield BS et al., Am J Surg Pathol 39:977-82, 2015). This IHC test is clinically indicated for diagnostic purposes. Specifically, it will be used in conjunction with P16 FISH probe to separate benign from malignant mesothelial proliferations, and is particularly useful when tissue invasion by mesothelial cells cannot be demonstrated. However, combined BAP1/p16 FISH testing is not highly sensitive, and negative results do not rule out a mesothelioma. Subcellular Localization: nuclear
Organ: Lung, Ovary
Disease State: Mesothelioma vs. Adenocarcinoma, Benign vs. Malignant Mesothelial Proliferations
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This sensitive breakapart FISH assay detects any translocation inolving the BCL6 gene but does not specifically distinguish between any of the many different BCL6 translocation partners (e.g., immunoglobulin heavy and light chain genes, the PIM1 gene, and the transferrin receptor gene). Chromosomal translocations involving bcl-6 on 3q27 are one of the most common genetic alterations in B cell non-Hodgkin lymphomas and have been described in up to 35% of diffuse large B cell lymphomas (DLBCLs), follicular lymphomas, and so-called "double-hit" aggressive B cell lymphomas. Detection of translocations involving the bcl-6 gene on 3q27 can be helpful in sub-classifying B cell lymphomas including where folliciluar lymphoma is in the differential and in the evaluation of aggressive B cell lymphomas where Burkitt' lymphoma, atypical Burkitt's, DLBCL, and B cell lymphomas that are intermediate between DLBCL and BL are being considered. Probe type: Dual color breakapart
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Burkitt's Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: BCMA, or B cell maturation antigen, is a plasma cell-associated surface antigen expressed by the great majority of benign and neoplastic plasma cells and by a smaller proportion of benign and neoplastic B cells.
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: This real time quantitative (RQ) PCR assay is performed on RNA extracted from fresh bone marrow or peripheral blood specimens. Results are reported using the International Scale, allowing for ready assessment of major molecular response (MMR). This test is indicated in the following settings: • To confirm the diagnosis of CML and ALL in new patients whose blood count suggests the diagnosis of a chronic myeloproliferative disorder or ALL. • To monitor response to therapy in ALL. • To monitor response to therapy in CML: In Chronic myelogenous leukemia (CML), RQ-BCR-ABL Mbcr PCR is recommended to be performed on a peripheral blood specimen in every new patient prior to therapy and then afterwards at 3 month intervals to monitor patient responsiveness to anti-tyrosine kinase therapy. Once complete cytogenetic remission is achieved BCR-ABL Mbcr transcript monitoring can be reduced to every 12 months. Type: Reverse Transcription PCR, Quantitative
Organ:
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML)
Turnaround Time: Within 4-8 business days of receipt
Schedule: Started Monday, out for analysis on Tuesday
Specimen Requirements: • Specimen MUST be received within 48 hrs of collection • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): 81206. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: This real time quantitative (RQ) PCR assay is performed on RNA extracted from fresh bone marrow or peripheral blood specimens. Results are reported as a ratio of p190 transcript to ABL1 transcript. This test is indicated in the following settings: • To confirm the diagnosis of CML and ALL in new patients whose blood count suggests the diagnosis of a chronic myeloproliferative disorder or ALL. • To monitor response to therapy in ALL. • To monitor response to therapy in CML: In Chronic myelogenous leukemia (CML), RQ-BCR-ABL mbcr PCR is recommended to be performed on a peripheral blood specimen in every new patient prior to therapy and then afterwards at 3 month intervals to monitor patient responsiveness to anti-tyrosine kinase therapy. Once complete cytogenetic remission is achieved BCR-ABL mbcr transcript monitoring can be reduced to every 12 months. Type: Reverse Transcription PCR, Quantitative
Organ:
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML)
Turnaround Time: Within 4-8 business days of receipt
Schedule: Started Monday, out for analysis on Tuesday
Specimen Requirements: • Specimen MUST be received within 48 hrs of collection • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): 81207. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: PhenoPath’s real-time PCR assay utilizes allele-specific PCR to detect BRAF V600 mutations, including the V600E BRAF mutation (c.1799T>A) as well as a subset of other less common activating BRAF V600 mutations (such as V600K, V600D, etc); however, these mutations cannot be distinguished by this assay. BRAF V600 mutations occur in a variety of human malignancies, including (but not limited to) subsets of colorectal carcinomas, papillary thyroid carcinomas, melanomas*, gastrointestinal stromal tumors (GIST) that are negative for KIT and PDGFRA mutations, CNS neoplasms, malignant peripheral nerve sheath tumors, Langerhans cell histiocytoses, and Erdheim-Chester disease; and in virtually all cases of hairy cell leukemia. In colorectal carcinomas, the V600E mutation has been associated with a lack of response to epidermal growth factor receptor (EGFR) targeted therapies (cetuximab or panitumumab). When evaluated in conjunction with KRAS/NRAS mutation testing, BRAF V600 mutation analysis may predict response to these therapies. Determination of BRAF mutation status can also be useful in the work-up hereditary non-polyposis colorectal carcinomas (HNPCC), as BRAF V600 mutations are found in non-hereditary/sporadic CRC cases exhibiting microsatellite instability, but not in HNPCC. *For BRAF V600 testing in melanomas, please see BRAF IVD cobas v600.
Organ: Lung, Brain/CNS, Skin & Mucosa, Blood/Bone Marrow, Colon & Other GI, Thyroid, Lymph Node / Spleen
Disease State: Hairy Cell Leukemia, Langerhans Cell Histiocytosis, Oligodendroglioma, Astrocytoma, Adenocarcinoma, Lynch Syndrome / HNPCC
Turnaround Time: Within 3-6 business days of receipt
Schedule: Tuesday and Friday
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block, 10 FFPE tissue slides, or peripheral blood or bone marrow in EDTA or heparin.
CPT Code(s): 81210; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The FDA-approved cobas 4800 BRAF V600 mutation test (IVD) is a real-time PCR assay designed to detect the presence of activating BRAF V600 mutations in melanoma and is the companion diagnostic test for the vemurafenib, a BRAF inhibitor. This assay will detect the V600E BRAF mutation (T1799A) as well as a subset of other less common activating BRAF V600 mutations (including some V600K BRAF mutations). BRAF mutations have been identified in 40% - 60% of malignant melanomas as well as other human cancers including colorectal cancer, ovarian cancer, and thyroid cancer. BRAF is part of a highly regulated signaling pathway that mediates the effects of growth factor receptors (such as EGFR) through RAS, RAF, MEK and ERK. Oncogenic mutations in BRAF result in a gain of kinase function, rendering the RAF-MEK-ERK pathway constitutively active in the absence of typical growth factors.
Organ: Skin & Mucosa
Disease State: Melanoma
Turnaround Time: Within 4-8 business days of receipt
Schedule: Wednesday
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): 81210; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies pCAM, a glycoprotein expressed in the vast majority of adenocarcinoma and almost always negative in mesothelioma (negative). Best used as part of a panel including antibodies to other glycoproteins such as the MOC-31 antibody to epithelial glycoprotein-2 and the Bg8-defined Lewis Y antigen. Subcellular Localization: Membranous and cytoplasmic
Organ: Lung
Disease State: Mesothelioma vs. Adenocarcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Abnormal nuclear localization of beta catenin generally indicates the presence of a mutation in WNT/APC pathway. Such mutations are characteristic of abdominal fibromatoses. High levels of nuclear beta catenin expression can also be seen in endometrial stromal tumors, synovial sarcomas, solitary fibrous tumors, and a subset of colorectal and endometrial adenocarcinoma. Subcellular Localization: Cytoplasmic and membranous (normal); nuclear (abnormal)
Organ: OB/GYN, Pancreas
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies the Lewis Y blood group related antigen, which has been demonstrated to be a sensitive marker of adenocarcinoma, not expressed, or expressed only at very low levels, in mesothelial cells or mesothelioma. Subcellular Localization: Membranous and cytoplasmic
Organ: Lung
Disease State: Mesothelioma vs. Adenocarcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies all epithelial tissues expressing the blood group A. Useful for identification of floaters, i.e., of contaminating tissues derived from patients of different blood group types. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State: Identification of Floaters
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies all epithelial tissues expressing the blood group B. Useful for identification of floaters, i.e., of contaminating tissues derived from patients of different blood group types. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State: Identification of Floaters
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies all normal B cells throughout maturation (from immature forms to plasma cells). Bob-1 and Oct-2 are co-expressed in almost all non-Hodgkin lymphomas, plasma cell neoplasms, and nodular lymphocyte predominance lymphomas, but one or both is aberrantly lost in nearly all cases of classical Hodgkin lymphoma. Subcellular Localization: Nuclear
Organ:
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Classical Hodgkin Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies chordomas. Negative in chondromatous and myxoid tumors. Subcellular Localization: Nuclear
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The IHC Breast Multiplex assay is intended for the qualitative identification of Keratin 5/14, p63 protein and Keratin 7/18 by two color immunohistochemistry (IHC). This multiplex assay has two diagnostic applications: 1. Invasive carcinoma versus non-invasive lesions: The presence of myoepithelial cells around suspicious cells nests argues against a diagnosis of invasive carcinoma and can aid in identifying a non-invasive entity, such as carcinoma in situ, atypical ductal hyperplasia (ADH), usual ductal hyperplasia (UDH), and sclerosing adenosis. 2. Usual ductal hyperplasia versus atypical ductal hyperplasia and carcinoma in situ: The presence of staining for Keratin 5 among the luminal cells of a hyperplastic breast lesion can aid in distinguishing usual ductal hyperplasia (typically positive for Keratin 5) from atypical ductal hyperplasia/carcinoma in situ (typically negative for Keratin 5).
Organ: Breast
Disease State: Adenocarcinoma, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88344. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: FISH studies for inv(16) / t(16;16)(p13;q22) are clinically indicated in new diagnoses of acute myeloid leukemia (AML) for proper diagnostic classification, as the inv16/t(16;16) is a recurrent chromosomal abnormality in AML. FISH testing for this abnormality may also be indicated for follow-up studies to monitor disease progression and response to therapy. Translocations/inversions of chromosome 16 are found in about 10% of AML, with approximately half of these cases being AML M4 subtype with abnormal eosinophilia. The CBFB-MYH11 fusion gene is formed due to a pericentric inversion on chromosome 16, inv(16)(p13q22), or in rare instances, is due to a translocation: t(16;16)(p13;q22). Probe type: Dual color breakapart
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD10 ia a follicular B cell surface marker also known as CALLA. It is also expressed in a subset of non-hematopoietic tumors, including atypical fibroxanthoma.
Organ: Breast, Skin & Mucosa
Disease State: Spindle Cell Tumors / Sarcoma Subtyping, Angioimmunoblastic T Cell Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD103, or integrin αE, is preferentially expressed in human intestinal intraepithelial lymphocytes (IELs) and in specific types of lymphoid tumors. The main areas of diagnostic interest are the identification of hairy cell leukemia (HCL, almost always CD103+), and the distinction from marginal zone lymphomas and other potential HCL mimics (usually, but not always, CD103-negative). One other potential use of this antibody is the identification of intraepithelial gastrointestinal T cells (usually CD103+) and enteropathy-associated T cell lymphoma (EATL), a malignancy derived from these T cells, often in the setting of underlying celiac disease. Due to the the fact that CD103 is not a lineage-specific antigen, PhenoPath's policy is to run the B cell marker PAX-5 in conjunction with all CD103 test orders. Ref: AJCP 139:220-230, 2013 Subcellular Localization: Cytoplasmic and membranous with membranous accentuation
Organ: Blood/Bone Marrow, Colon & Other GI, Lymph Node / Spleen
Disease State: Hairy Cell Leukemia, Marginal Zone/MALT Lymphoma, T Cell Non-Hodgkin Lymphoma (not otherwise classified)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • Minimum of 4 unstained slides cut at 4µm
CPT Code(s): 88342 and 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies the interleukin-3 receptor. CD123 is strongly expressed in plasmacytoid dendritic cell neoplasms, at variable intensity in all classical hairy cell leukemia, most B-ALLs, and in a subset of AMLs. Subcellular Localization: Membranous
Organ:
Disease State: Hairy Cell Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies syndecan-1, a cell surface-associated protein expressed in plasma cells and plasmacytoid B cells, and on neoplasms derived from these cells, including almost all plasmacytic/plasmablastic neoplasms. CD138 is also expressed by a significant subset of normal and neoplastic epithelia. Subcellular Localization: Membranous
Organ:
Disease State: B Cell NHL with Plasmacytoid Differentiation
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The expression of CD14 by IHC is a useful biomarker for distinguishing neoplasms of monocytic and Langerhans cell origin from other hematolymphoid neoplasms. CD14 is a glycoprotein expressed on mature monocytes, histiocytes/macrophages, Langerhans cells, and to a lesser degree on neutrophils, and is a receptor for bacterial lipopolysaccharide (LPS), thus functioning as an opsonic receptor to facilitate phagocytic uptake. Subcellular Localization: Membranous and cytoplasmic
Organ: Lung, Skin & Mucosa, Blood/Bone Marrow, Lymph Node / Spleen, Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML), Langerhans Cell Histiocytosis, Myelodysplastic Syndromes
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: A cytoplasmic- and cell surface-associated protein that is strongly expressed by granulocytes at the promyelocyte and later stages, and is expressed at lower levels on monocytes/histiocytes. CD15 is aberrantly coexpressed by myeloid blasts in a subset of myeloid stem cell neoplasms. In addition, CD15 is expressed in a membrane and/or Golgi pattern in the majority of cases of classical Hodgkin lymphoma. Finally, CD15 is expressed by a subset of normal and neoplastic epithelia. Subcellular Localization: Membranous
Organ:
Disease State: Classical Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD163 is a transmembrane protein that acts as a scavenger receptor, and is restricted in its expression to the monocytic/macrophage lineage. It is present on all circulating monocytes and most tissue macrophages except those found in the mantle zone and germinal centers of lymphoid follicles, interdigitating reticulum cells and Langerhan’s cells. Subcellular Localization: Membranous
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD19, like the CD79 complex and cytoplasmic CD22, is a pan-B-lineage antigen that is first expressed in very early B-lymphoid progenitors, and continues to be expressed at variable levels through terminal B-lymphoid differentiation in plasma cells. With the exception of true plasma cell neoplasms and classical Hodgkin lymphoma, the great majority of mature and immature B-lymphoid neoplasms express CD19. Some neoplasms such as hairy cell leukemia overexpress CD19, while others such as follicular lymphoma typically underexpress CD19. Rare non-B-lymphoid neoplasms express CD19, most notably acute myeloid leukemia (AML) bearing the t(8;21). Subcellular Localization: Mainly membranous; partially cytoplasmic
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), B Cell NHL with Plasmacytoid Differentiation, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Hairy Cell Leukemia, HIV-Associated Lymphoma, Mantle Cell Lymphoma, Marginal Zone/MALT Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma, Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Plasma Cell Myeloma/Neoplasm, Lymphoplasmacytic Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD1a is a cell surface-associated protein expressed at the "dual-positive" stage of T cell development, which is the stage at which CD4 and CD8 are coexpressed on immature T cells in the thymus. CD1a is expressed on a subset of precursor T lymphoblastic leukemias/lymphomas corresponding to this stage of T cell development. CD1a is also expressed on the great majority of normal and neoplastic Langerhans cells. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State: Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL), Langerhans Cell Histiocytosis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD2 is a cell surface-associated protein expressed in both mature and immature T cells, as well as natural killer (NK) cells. CD2 is aberrantly decreased in a subset of T cell and natural killer cell neoplasms. Rare cases of acute myeloid leukemia show aberrant coexpression of CD2 on the leukemic blasts. Subcellular Localization: Membranous
Organ:
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, NK/T Cell Lymphoma, Nasal Type, Mastocytosis, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD20 is a cell surface-associated protein expressed during the middle to later stages of B cell maturation in the bone marrow, and on all normal mature B cells. CD20 ceases to be expressed at the terminal differentiation of B cells to plasma cells. CD20 is expressed on the great majority of mature B cell neoplasms, and on a significant subset of immature B cell neoplasms, but only rarely on plasmacytic neoplasms. CD20 is the target of the therapeutic antibody known as Rituxan. Subcellular Localization: Membranous
Organ: Blood/Bone Marrow
Disease State: Large Cell Undifferentiated Malignant Neoplams, B Cell Non-Hodgkin Lymphoma (not otherwise classified), Classical Hodgkin Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD200, a cell surface antigen expressed in a variety of benign and neoplastic tissues, is thought to promote immune evasion by tumors. CD200 evaluation can help distinguish chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL, usually CD200-positive) from mantle cell lymphoma (almost always CD200-negative). Subcellular Localization: Membranous and cytoplasmic
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Angioimmunoblastic T Cell Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD21 is a cell surface-associated protein expressed in the follicular dendritic cells (FDCs) of lymphoid tissues, and in tumors derived from FDCs. Disruption of CD21-positive FDC meshworks can be seen in a variety of lymphomas. CD21 is also expressed by a significant subset of B cells, and is the receptor for Epstein-Barr virus. Subcellular Localization: Membranous
Organ:
Disease State: Angioimmunoblastic T Cell Lymphoma, Follicular Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma, Follicular Dendritic Cell Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD22 is a B cell specific surface antigen expressed in mature B cells, and positive on B-cell neoplasms such as mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Subcellular Localization: Membranous
Organ:
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD23 is a cell surface-associated protein expressed on a subset of activated B cells, and on a large subset of follicular dendritic cells (FDCs). CD23 tends to be strongly coexpressed with CD5 on the neoplastic B cells of chronic lymphocytic leukemia/small lymphocytic lymphoma. Subcellular Localization: Membranous
Organ:
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Follicular Lymphoma, Follicular Dendritic Cell Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD25 (IL-2Rα) is a cell surface-associated protein that is the receptor for interleukin-2. CD25 is expressed on a significant subset of activated T cells, and tends to be strongly expressed on the neoplastic T cells of adult T cell leukemia/lymphoma and anaplastic large cell lymphoma. CD25 is also coexpressed on a subset of B cell neoplasms, most notably hairy cell leukemia. Aberrant CD25 expression on mast cells is an important immunophenotypic clue to the diagnosis of systemic mastocytosis. Subcellular Localization: Membranous
Organ:
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Hairy Cell Leukemia, Mastocytosis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD3 is a multimeric cell surface-associated protein expressed in T cells in association with the T cell antigen receptor. Cell surface CD3 begins to be expressed during T cell development in the thymus, and is expressed throughout later T cell maturation. CD3 is aberrantly decreased in a subset of T cell neoplasms. NK cells do not express surface CD3, but do express the epsilon chain of CD3 in the cytoplasm. Subcellular Localization: Membranous
Organ:
Disease State: Angioimmunoblastic T Cell Lymphoma, NK/T Cell Lymphoma, Nasal Type, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD30 is a cytoplasmic- and cell surface-associated protein expressed by a significant subset of activated B cells and T cells. CD30 is expressed at variable levels by Reed-Sternberg cells and variants in the majority of cases of classical Hodgkin lymphoma. Among the non-Hodgkin lymphomas, CD30 is strongly and uniformly expressed in anaplastic large cell lymphoma, and at variable levels in a significant subset of other non-Hodgkin lymphomas, particularly those of large cell type. CD30 is also expressed by embryonal carcinomas. Subcellular Localization: Membranous and cytoplasmic
Organ: OB/GYN, Genitourinary, Testis, Ovary
Disease State: Large Cell Undifferentiated Malignant Neoplams, Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Classical Hodgkin Lymphoma, Mastocytosis, Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies PECAM-1, a cell surface adhesion molecule expressed on the surface of endothelial cells and is an excellent marker of vascular neoplasms, e.g., angiosarcoma. CD31 can also be expressed by platelets, macrophages, and plasma cells. Subcellular Localization: Membranous
Organ:
Disease State: Large Cell Undifferentiated Malignant Neoplams, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies myeloid progenitors, monocytes, and macrophages. Acute and chronic myelogenous and monocytic leukemias, as well as acute lymphoblastic leukemias, express CD33. Some cases of multiple myeloma also express CD33. Subcellular Localization: Membranous
Organ:
Disease State: Plasma Cell Myeloma/Neoplasm, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD34 is a transmembrane sialomucin expressed in lymphohematopoietic stem and progenitor cells, as well as endothelial cells. It is also a marker of a unique subset of mesenchymal tumors (e.g., solitary fibrous tumor, dermatofibrosarcoma protuberans, epithelioid sarcoma, gastrointestinal stromal tumor, etc.). Subcellular Localization: Membranous
Organ: Skin & Mucosa, Liver, Colon & Other GI
Disease State: Large Cell Undifferentiated Malignant Neoplams, Spindle Cell Tumors / Sarcoma Subtyping, Hepatocellular Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD38 is a 46 kDa type II transmembrane glycoprotein with a short N-terminal cytoplasmic tail (20 amino acids) and a long extracellular domain (256 amino acids). CD38 is expressed by a variety of leukocytes, including plasma cells (which show the highest levels of expression), immature and mature B and T cells, NK cells, monocytes, macrophages, and myeloid progenitors. It has enzymatic activity as a cyclic ADP ribose hydrolase, which contributes to the regulation of intracellular calcium. The ligand of CD38 is CD31. In mature B cells, CD38 expression is induced once naive B lymphocytes are activated, reaches a first peak when B cells enter the germinal center, decreases during centrocyte/centroblast differentiation, is completely absent in memory B cells, and reaches its maximum levels as B cells terminally differentiate to plasma cells. In HIV, increased T-cell CD38 expression is associated with disease progression. CD38 expression has been described in some non-hematopoietic tissues. Subcellular Localization: Membranous
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: B Cell NHL with Plasmacytoid Differentiation, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), HIV-Associated Lymphoma, Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Plasma Cell Myeloma/Neoplasm, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Lymphoplasmacytic Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD4 is a cell surface-associated protein expressed at relatively high levels in helper T cells, and at lower levels in monocytes. CD4 is also the receptor for HIV. CD4 is aberrantly decreased in a subset of T cell neoplasms, and is commonly expressed in monocytic/histiocytic neoplasms. Subcellular Localization: Membranous
Organ:
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, Blastic Plasmacytoid Dendritic Cell Neoplasm, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD42b, also known as platelet glycoprotein Ib, is a cell surface and transmembrane glycoprotein, expression of which commences somewhat later in megakaryocytic development compared to CD61. CD42b is also expressed by platelets.  A subset of cases of Bernard-Soulier syndrome involve congenital deficiency of CD42b. Subcellular Localization: Membranous
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies leukosialin, expressed on all leukocytes except resting B lymphocytes. Co-expression of CD43 with CD20 is a feature of a subset of low-grade lymphomas. Subcellular Localization: Membranous
Organ:
Disease State: Small, Blue, Round Cell Tumors, Large Cell Undifferentiated Malignant Neoplams, Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma, Marginal Zone/MALT Lymphoma, NK/T Cell Lymphoma, Nasal Type, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Blastic Plasmacytoid Dendritic Cell Neoplasm, Langerhans Cell Histiocytosis, Lymphoplasmacytic Lymphoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies leukocyte common antigen (LCA), a family of cell surface proteins expressed at variable levels in all normal hematopoietic cells, with the exception of erythroid cells that have matured beyond the proerythroblasts stage. A variety of hematopoietic neoplasms show aberrant increases or decreases in the level of CD45 expression. Aberrant loss of CD45 is seen in a subset of precursor B-lymphoblastic leukemias, in the majority of multiple myelomas, and in nearly all cases of classical Hodgkin's lymphoma (on Reed-Sternberg cells and variants). Subcellular Localization: Membranous
Organ:
Disease State: Large Cell Undifferentiated Malignant Neoplams, Angioimmunoblastic T Cell Lymphoma, Classical Hodgkin Lymphoma, NK/T Cell Lymphoma, Nasal Type, Nodular Lymphocyte-Predominant Hodgkin Lymphoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD5 is a cell surface-associated protein expressed in mature and immature T cells, but not in NK cells. CD5 is aberrantly decreased in a subset of T cell neoplasms. CD5 shows characteristic aberrant expression by two B cell neoplasms, chronic lymphocytic leukemia/small lymphocytic lymphoma and mantle cell lymphoma, although a small number of other B cell neoplasms can show low-level coexpression of CD5. Subcellular Localization: Membranous
Organ:
Disease State: Angioimmunoblastic T Cell Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube assesses CD52 and CD22 on CD5+ B cell neoplasms (i.e., CLL/SLL and MCL). In addition to these two antibodies, this tube includes antibodies to CD45, CD19, CD5, CD49d, and CD79b; the latter two antibodies can aid in the distinction of CLL/SLL from MCL.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x7. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies neural cell adhesion molecule (NCAM), a cell surface-associated protein expressed by NK cells and a subset of activated T cells, in addition to a variety of neuroectodermally-derived structures. CD56 is expressed on the majority of NK cell neoplasms, and on a subset of T cell neoplasms. CD56 is aberrantly expressed by myeloid blasts, granulocytes, and/or monocytes in a subset of acute myeloid leukemias and myelodysplastic/myeloproliferative syndromes, and by the neoplastic plasma cells in a large subset of multiple myelomas. Finally, CD56 is strongly expressed by small blue round cell tumors of neuroectodermal origin, and by neuroendocrine carcinomas. Subcellular Localization: Membranous
Organ: Brain/CNS
Disease State: Small, Blue, Round Cell Tumors, NK/T Cell Lymphoma, Nasal Type, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD57 is a cell surface-associated protein expressed on a subset of activated T cells, including so-called large granular lymphocytes, and neoplasms derived from these cells. CD57 is also expressed on a variety of neural structures. Identification of CD57-positive cells is of value in positively identifying lymphocyte-predominant Hodgkin lymphoma. Subcellular Localization: Membranous
Organ:
Disease State: Spindle Cell Tumors / Sarcoma Subtyping, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies the ITGB3 gene product, also known as integrin beta chain beta 3. It is employed as a marker of megakaryocytes and platelets. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a cytoplasmic/lysozomal-associated protein expressed by normal and neoplastic monocytes/histiocytes, including Langerhans cells. Neoplasms of lymphoid origin are usually negative, although some B cell neoplasms, most frequently small lymphocytic lymphoma and hairy cell leukemia, show weak staining of the cytoplasm, usually in the form of a few scattered granules. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Langerhans Cell Histiocytosis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD7 is a cell surface-associated protein expressed in both mature and immature T cells, as well as NK cells. CD7 is aberrantly decreased in a subset of T cell and natural killer cell neoplasms. In addition, a significant subset of myeloid stem cell neoplasms, including acute myeloid leukemia and myelodysplastic or myeloproliferative syndromes, demonstrates aberrant coexpression of CD7 on the myeloid blasts. Subcellular Localization: Membranous
Organ:
Disease State: Angioimmunoblastic T Cell Lymphoma, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies transferrin receptor (CD71), required for delivery of iron from transferrin to cells. In clinical practice, CD71 displays specificity for erythrocyte precursors in normal and abnormal bone marrow sections. Subcellular Localization: Strong membranous staining with weak cytoplasmic staining in some cases
Organ: Blood/Bone Marrow
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD79a is a cytoplasmic antigen expressed at all stages of B cell maturation, from lymphoblasts through plasma cells. CD79a expression is decreased in most cases of classical Hodgkin lymphoma, and in a subset of non-Hodgkin B cell lymphomas. Subcellular Localization: Membranous
Organ:
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Classical Hodgkin Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies cell surface-associated protein expressed at relatively high levels by cytotoxic/suppressor T cells (which express the alpha-beta heterodimer of CD8), and at lower levels by gamma-delta T cells and natural killer cells (both of which express the alpha-alpha homodimer of CD8). CD8 is aberrantly decreased in a subset of T cell and NK cell neoplasms. Subcellular Localization: Membranous
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CD99 has historically been used as a marker of PNET/Ewing sarcoma, as well as a subset of spindle cell tumors, including synovial sarcoma and solitary fibrous tumor, although there are other more specific markers now available for these latter tumors. Use of CD99 is not recommended; please contact one of our pathologists for alternative markers. Subcellular Localization: Membranous
Organ:
Disease State: Small, Blue, Round Cell Tumors, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Cadherin 17 is a component of the gastrointestinal tract and pancreatic ducts, acting as an intestinal proton-dependent peptide transporter in the first step in oral absorption. Cadherin 17 is expressed in the epithelial cells of embryonic and adult small intestine, colon, and pancreatic ducts. It has also been reported to be frequently expressed in adenocarcinomas arising in the gastrointestinal tract and pancreas. Owing to its restricted expression in these groups of tumors, cadherin 17 can be a useful immunohistochemical marker for assisting in distinguishing these neoplasms from other malignancies. The performance characteristics of this antibody have been established within the context of carcinomas arising at different primary sites. This anti-cadherin 17 antibody displays a sensitivity of 95% and a specificity of 95% for colorectal adenocarcinoma. Subcellular Localization: predominantly membranous with a smaller cytoplasmic component
Organ: Colon & Other GI
Disease State: Carcinomas of Unknown Primary, Adenocarcinoma, Metastatic Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CDX2 is an intestinal-specific transcription factor, highly expressed in colorectal adenocarcinomas, with a sensitivity > 95%, and also expressed, at lower levels, and with a lower sensitivty, in the vast majority of non-colorectal GI carcinomas, i.e., those primary to the pancreatobiliary tract and stomach. CDX2 is also expressed in neuroendocrine carcinomas of the GI tract. Subcellular Localization: Nuclear
Organ: Liver, Colon & Other GI, Pancreas
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies "true" CEA, also known as CD66e, expressed by a subset of epithelial cells and carcinomas. Subcellular Localization: Cytoplasmic
Organ: Liver
Disease State: Hepatocellular Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: FISH
Clinical Significance: A recurrent problem in surgical pathology specimens is specimen mix-up and contamination of a patient's specimen by "floaters." While many of these cases can be resolved histologically or immunophenotypically using blood group antigen immunohistochemistry, a significant number of cases may not be resolved by these modalities and can have serious clinical and medicolegal implications. Use of fluorescence in situ hybridization (FISH) to perform sex genotyping on tissue specimens with potential tissue contaminants is an effective and reliable means of potentially resolving problems of floater contamination. Minute tissue samples provide sufficient target DNA and nuclei for FISH studies. This assay confirms the presence of these sex chromosomes within the cells of interest. Presence of two green X chromosome signals is indicative of an XX female genotype, whereas the presence of a single green X chromosome and single orange Y chromosome signal are indicative of an XY male genotype. Probe type: Dual color enumeration
Organ:
Disease State: Identification of Floaters
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88366. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88367 or 88373. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Partial hydatidiform moles have defined histologic abnormalities including dual discrete populations of villi, circumferential mild trophoblastic hyperplasia, trophoblastic inclusions, scalloping of villi, and cistern formation. Nonetheless, morphologic features alone may not be sufficient to confirm the diagnosis of partial hydatidiform mole in some cases, particularly those in the early first trimester. Furthermore, there is significant inter- and intra-observer variability in the diagnosis of hydatidiform mole, with significant problems in differentiating partial hydatidiform moles from hydropic spontaneous abortions. In this assay, the CEP17 probe is used for analysis and interpretation of ploidy status. Identification of triploidy by CEP17 FISH helps to confirm the diagnosis of partial hydatidiform mole and can be used to separate partial hydatidiform moles from complete hydatidiform moles and hydropic products of conception. Probe type: Enumeration (single-color)
Organ: OB/GYN
Disease State: Molar Pregnancy
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested plus 2 unstained slides cut at 6µm
CPT Code(s): 88367 or 88373. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH test detects Trisomy 8, which is a chromosomal abnormality seen in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This FISH test is frequently utilized in the workup of MDS, which is a heterogeneous group of clonal myeloid stem cell disorders. Trisomy 8 as a sole abnormality is associated with an intermediate prognosis. Probe type: Single color enumeration
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88367 or 88373. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: In combination with CD5+ B cell therapy tube, this tube helps distinguish CLL/SLL from mantle cell lymphoma. This tube includes antibodies to CD45, FMC7, CD19, CD22, CD5, CD23, CD200, and CD43.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x10. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) has several recurrent and prognostic genetic alterations that have been characterized and are useful in the management of patients. Loss of 13q14.3 is the most common molecular alteration in CLL/SLL (~36% of all CLL/SLL cases) and as a sole abnormality often portends a favorable clinical course. Loss of 17p13.1(P53) or 11q22.3(ATM) are less common and are adverse prognostic markers in CLL/SLL. Trisomy 12, as detected by CEP12 FISH is a marker of intermediate prognosis. This panel includes IGH and t(11;14) FISH probes to aid in the differentiation of CLL/SLL cases from mantle cell lymphoma.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374x5, 88367. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: The hallmark of chronic myelogenous leukemia (CML) is the presence of the BCR-ABL fusion gene associated with the Philadelphia chromosome (Ph). All cases of CML have a t(9;22) or variant and detection of this genetic abnormality is important in the diagnosis of CML. The BCR/ABL fusion gene resulting from the t(9;22) is the target for the tyrosine kinase inhibitor drug imatinib.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: CXCL13 is a chemokine that is a relatively specific marker of follicular helper T cells (TFH cells), the presumed cell of origin in angioimmunblastic T cell lymphoma and, to a lesser extent, other peripheral T cell lymphomas.  Importantly, CXCL13 is a less sensitive but more specific marker of TFH cells than CD10, bcl-6, or PD-1.    By immunohistochemistry, CXCL13 shows granular cytoplasmic reactivity in well-fixed FFPE, but may yield false negative results in suboptimally fixed FFPE. Subcellular Localization: Cytoplasmic (typically granular)
Organ: Blood/Bone Marrow, Lymph Node / Spleen, Soft Tissue
Disease State: Angioimmunoblastic T Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies C cells of the thyroid and medullary thyroid carcinomas. Subcellular Localization: Cytoplasmic
Organ: Thyroid
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Smooth muscle marker that is useful in the identification of leiomyosarcoma. Generally negative in endometrial stromal tumors. Subcellular Localization: Cytoplasmic
Organ: OB/GYN
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Calponin is a smooth muscle specific cytoskeletal protein useful in the identification of smooth muscle tumors and myoepithelium. Calponin is useful as a tool to demonstrate the presence of myoepithelium around suspicious cell nests and, as part of a panel, is helpful in distinguishing in situ vs. invasive lesions. Subcellular Localization: Cytoplasmic
Organ: Breast
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: Length-affecting mutations (insertions or deletions) within exon 9 of the Calreticulin (CALR) gene have been described in approximately 70% of essential thrombocythemia (ET) and approximately 60-80% of primary myelofibrosis (PMF) patients without JAK2 or MPL mutations. CALR exon 9 insertion/deletion mutations have not been identified in polycythemia vera (PV) patients.
Organ: Blood/Bone Marrow
Disease State: Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML)
Turnaround Time: Within 4-8 business days of receipt
Schedule: Friday
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block, 10 FFPE tissue slides, or peripheral blood or bone marrow in EDTA or heparin.
CPT Code(s): 81219. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Antibodies to calretinin have been demonstrated to be a sensitive and relatively specific marker of mesothelial cells and mesothelioma, helping to distinguish the latter from adenocarcinoma. Also identifies ovarian stromal tumors. Subcellular Localization: Nuclear and cytoplasmic
Organ: Lung, OB/GYN, Ovary
Disease State: Mesothelioma vs. Adenocarcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies renal cell carcinoma, as well as other clear cell carcinomas, e.g., from urothelium and adrenal cortex. May also provide prognostic information in CRCC, with low CA-IX expression correlating with poor survival. Subcellular Localization: Cytoplasmic and membranous
Organ: Genitourinary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Cathepsin K is a protease that is involved in bone resorption, and is highly expressed in osteoclast. Its expression has also been demonstrated in normal skin and lung fibroblasts. In neoplastic tissue, Cathepsin K has been reported to be expressed in most mesenchymal tumors, but only rarely in carcinomas. Cathepsin K is positive in the majority of translocation renal cell carcinomas (seven of the Alpha-TFEB gene fusion translocation), and in all 5 of the most common TFE3-positive renal cell carcinomas bearing the t(X;1)(p11.2;q21) translocation. This assay is intended for the identification of these renal cell carcinomas. Published data suggest that TFE3 expression leads to cathepsin K expression. While less sensitive than TFE3, cathepsin K has also been demonstrated in a subset of renal cell carcinomas showing a different translocation, t(6;11). While these latter translocations cannot be identified with antibodies to TFE3, they may account for the apparent reduced specificity of cathepsin K in our study, as the TFE3-negative, Cathepsin K-positive renal cell carcinomas may well correspond to these t(6;11) translocation renal cell carcinomas. Final determination of translocation status in renal cell carcinomas may require FISH or PCR studies. Subcellular Localization: Cytoplasmic
Organ: Genitourinary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a protein unique to the dense core granules of neuroendocrine cells and tumors. It is an excellent marker for carcinoid tumors, pheochromocytomas, paragangliomas, but not as good a marker of high-grade neurendocrine carcinomas as synaptophysin. Subcellular Localization: Cytoplasmic, often with a granular pattern
Organ: Colon & Other GI, Pancreas
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Cytogenetics
Clinical Significance: Chromosomal analysis studies are available on the following specimen types: Bone marrow, peripheral blood, lymph node or other neoplastic tissues with suspect hematologic abnormalities.
Organ:
Disease State:
Turnaround Time: Blood, bone marrow aspirates and lymph nodes: 5-7 business days; Solid Tumor: 10-14 business days
Schedule: Monday-Saturday
Specimen Requirements: • Bone Marrow Aspirate: In sodium heparin (Green Top vacutainer), 1-2 ml - OR - • Peripheral Blood: In sodium heparin (Green top vacutainer), 5 ml; patient should have WBC of 15,000 or higher, with 10% circulating immature myeloid or lymphoid blast cells - OR - • Solid Tumor Tissue/ Lymph Node: In sterile RPMI or tissue culture media • STORAGE TEMP: Room temperature • NOTE: EDTA is NOT acceptable for cytogenetics studies
CPT Code(s): 88237, 88264, 88280, 88291 (may include 88285 or additional units of 88280; 88239 used in lieu of 88237 for solid tumor). The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a heterodimeric protein associated with clearance of cell debris and apoptosis. It is expressed in diffuse large B-cell lymphomas (DLBCL), T-cell rich large B-cell lymphoma, Hodgkin lymphoma, as well as various carcinomas. Clusterin has proven to be an effective tool in the differentiation of anaplastic large cell lymphoma (ALCL) from peripheral T cell lymphoma (PTCL), NOS. Subcellular Localization: Cytoplasmic, in a granular diffuse and/or a Golgi pattern
Organ:
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Diffuse Large B Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Immunofluorescence
Clinical Significance: Identifies: C3 localization by direct immunofluorescence is useful in the subclassification of bullous and other skin disorders, particularly when employed as part of a panel of FITC-conjugated antibodies, including those to IgG, IgM and IgA. Subcellular Localization: Extracellular
Organ: Skin & Mucosa
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: Skin biopsy in Michel's (aka Zeuss) fixative, with or without patient serum
CPT Code(s): 88346 or 88350. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State: Amyloid Type Analysis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide cut at 8µm plus 2 unstained slide cut at 8-10µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Plasma cell myeloma (or multiple myeloma) is a malignant disorder in which clonal plasma cells accumulate in the bone marrow. This incurable disease is heterogeneous, with survival range varied from a few weeks of diagnosis to more than ten years. Other groups have published numerous studies demonstrating the presence of hyperdiploidy is associated with a favorable prognosis as these patients showed less aggressive clinical features, prolonged remission and higher survival. Hyperdiploidy is characterized by trisomy or tetrasomy of chromosomes 3, 5, 7, 9, 11, 15, 19, and/or 21. Probe type: Enumeration
Organ: Blood/Bone Marrow, Body Fluids
Disease State: Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88367 or 88373. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies cyclin D1, one of the more frequently altered cell cycle regulators in cancers. Uniform overexpression of Cyclin D1, can be helpful in the identification of mantle cell lymphomas. Subcellular Localization: Nuclear
Organ:
Disease State: Hairy Cell Leukemia, Mantle Cell Lymphoma, Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Please see Keratin 17
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratin 19
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratin 20
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratin 5
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratin 7
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratins (AE1/AE3)
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratins (OSCAR)
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: Please see Keratins, high molecular weight (34βE12)
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: IHC
Clinical Significance: This clone identifies CMV infected cells in tissue sections. No cross-reactivity with other herpes viruses or adenoviruses. Subcellular Localization: Nuclear and cytoplasmic
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This two-tube assay is designed to confirm blast lineage in the setting of acute leukemia. These tubes include surface antibodies to CD45, CD34, CD117, CD19, and CD38; one tube contains antibodies to cytoplasmic myeloperoxidase, cytoplasmic CD79a, and cytoplasmic CD3, while the other tube contains isotype controls for the cytoplasmic antibodies.
Organ: Brain/CNS, Blood/Bone Marrow, Lymph Node / Spleen, Thymus (Mediastinal Mass)
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL), Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x8. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies DOG1, a novel marker of gastrointestinal stromal tumors (GISTs), and complements other markers such as c-kit (CD117). DOG1 is expressed in a significant subset of c-kit-negative GISTs. Subcellular Localization: Cytoplasmic and membranous
Organ: Colon & Other GI
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Desmin is an intermediate filament protein, expression of which is largely restricted to skeletal, smooth and cardiac muscle cells and tumors (e.g., leiomyosarcoma, rhabdomyosarcoma). Also expressed in reactive mesothelium and angiomatoid fibrous histiocytoma. Subcellular Localization: Cytoplasmic
Organ: Skin & Mucosa
Disease State: Small, Blue, Round Cell Tumors, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies E-cadherin, a transmembrane protein the function of which is cell-cell adhesion. Lobular carcinomas of the breast can be distinguished from ductal carcinomas by the presence in the former of genetic or epigenetic changes affecting the E-cadherin gene resulting in loss, or profound reduction, of expression of E-cadherin protein. Subcellular Localization: Membranous
Organ: Breast
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: CISH
Clinical Significance: Identifies: EBER-1, one of the Epstein-Barr virus (EBV)-encoded small non-polyadenylated RNAs (EBERs) that represent the most abundant viral transcripts in latently EBV-infected cells. Subcellular Localization: Nuclear
Organ:
Disease State: Identification of Organisms, Angioimmunoblastic T Cell Lymphoma, Burkitt's Lymphoma, Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, HIV-Associated Lymphoma, Post-Transplant Lymphoproliferative Disorders
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 3 unstained slides for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88365. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies EBV LMP-1 (latent membrane protein-1). EBV-LMP is a cell surface-associated protein encoded by the EBV genome and expressed by a subset of EBV-infected B cells, more commonly in tonsils than in lymph nodes of EBV-infected individuals. LMP-1 is a much less sensitive marker of EBV infection than EBER1 mRNA; the latter is detected by in situ hybridization. Subcellular Localization: Membranous
Organ:
Disease State: Identification of Organisms, Post-Transplant Lymphoproliferative Disorders
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies epidermal growth factor receptor (EGFR), a transmembrane protein expressed by a subset of carcinomas and other tumors. EGFR is the target of small molecules such as gefitinib and erolitinib, as well as humanized monoclonal antibodies such as cetuximab. Alterations in copy numbers of EGFR can be detected by FISH and mutations of EGFR gene can be detected by PCR. Subcellular Localization: Membranous
Organ: Lung, Colon & Other GI
Disease State: Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: EGFR gene amplification has been reported in a subset of colorectal adenocarcinomas, lung non-small cell carcinomas, and glioblastoma multiforme. Amplification the EGFR gene can often result in overexpression of epidermal growth factor and may contribute to tumorigenesis. With the availability of anti-EGFR monoclonal antibody therapy and small molecular EGFR inhibitors, assessment of EGFR gene amplification may be warranted in some tumors to predict those that may respond to anti-EGFR therapy. This FISH assay uses the established method described by Capuzzo et al., to evaluate tumors for EGFR high polysomy and amplification. Probe type: Dual color enumeration
Organ: Lung
Disease State: Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The Roche cobas® EGFR Mutation Test v2 is an FDA-approved companion diagnostic for both first and second line therapy decisions for patients with non-small cell lung carcinoma (NSCLC). This assay is FDA approved for identifying NSCLC patients with EGFR exon 19 deletions and exon 21 (L858R) substitution mutations for whom treatment with Tarceva® (erlotinib) may be effective as a first line therapy; and for identifying NSCLC patients who harbor a T790M mutation, indicating eligibility for treatment with Tagrisso® (osimertinib) as second line therapy. Per the FDA news release of November 13, 2015, Tagrisso® (AZD9291) is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR tyrosine kinase inhibitor therapy. Effective Tuesday, November 17, 2015, the Roche cobas® EGFR Mutation Test v2 replaced PhenoPath’s prior EGFR mutation assay. The Roche cobas® assay similarly uses qualitative real-time PCR to detect clinically relevant mutations in exons 18, 19, 20, and 21 of the EGFR gene and provides improved sensitivity as only 5% mutant allele is needed for reliable mutation detection in a background of wild-type DNA. In addition, the cobas® EGFR assay covers a greater number of mutations, identifying 42 mutations in exons 18-21, as compared to the 21 mutations covered by PhenoPath’s prior assay.
Organ: Lung
Disease State: Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 3-5 business days of receipt
Schedule: Tu, W, F
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): 81235; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The Roche cobas® EGFR Mutation Test v2 is an FDA-approved assay for identifying EGFR T790M, exon 19 deletions, and exon 21 L858R substitution mutations in circulating tumor DNA obtained from patients with non-small cell lung carcinoma. The identification of other clinically relevant EGFR mutations has been validated by PhenoPath Laboratories. Circulating tumor / “cell-free” DNA is isolated from plasma using the cobas® cfDNA Sample Preparation Kit; followed by amplification and detection of target DNA sequences using the cobas® z 480 analyzer. Please note that tumor samples (such as cytology preparations, biopsies and resection specimens) are the most robust method for determining EGFR mutation status. EGFR mutation testing of circulating tumor DNA in plasma is inherently more likely to produce a false negative result. When detected, EGFR mutations identified in circulating tumor DNA are associated with EGFR mutation-positive tumors; however, testing of tumor samples is recommended whenever possible.
Organ: Lung
Disease State: Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 3-5 business days of receipt
Schedule: Once per week
Specimen Requirements: --Minimum of 2 mL of plasma (following collection instructions below) --Recommend 4-6 mL of plasma for testing . Collection Instructions: --Venipuncture into K2-EDTA/plasma separator tube (ideally collect two to three 5 mL tubes; minimum of one 5 mL tube needed) --Within 4 hours of collection; separate plasma by centrifugation --Transfer plasma into transport tube --Immediately ship to PhenoPath frozen on dry ice
CPT Code(s): 81235. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH probe set detects deletion 5q31 and monosomy 5, which are chromosomal abnormalities seen in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This FISH test is frequently utilized in the workup of MDS, which is a heterogeneous group of clonal myeloid stem cell disorders. Deletion of 5q31 is associated with a favorable prognosis while monosomy 5 is associated with a poor prognosis. Patients with deletion 5q31 are eligible for Revlimid® (lenalidomide) therapy. Probe type: Dual color enumeration
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Epithelial membrane protein (EMA), a transmembrane glycoprotein encoded by the MUC1 gene. Expression of EMA can assist in the identification of metastatic v. primary cancers in the liver, nerve sheath tumors, meningioma, anaplastic large cell lymphoma, and other tumors. Subcellular Localization: Membranous
Organ:
Disease State: Large Cell Undifferentiated Malignant Neoplams, Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: ERG is a member of the ETS transcription factor gene family, whose members also include FLI1 and ETS1. It is strongly  expressed in endothelial cells and is a highly sensitive and specific marker of vascular neoplasms. Amongst carcinomas, expression of ERG is highly restricted to a subset (40-50%) of prostatic adenocarcinomas. (Miettinen M et al., Am J Surg Pathol. 35:432-41, 2011; Yaskiv O et al., Am J Clin Pathol 138:803-10, 2012). Subcellular Localization: Nuclear
Organ: Prostate, Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay detects most rearrangements involving the EWSR1 gene irrespective of translocation partner. Genetic approaches to identify rearrangements of the EWSR gene on chromosome 22q12, characteristic of over 90% of PNET/Ewing sarcomas, have become the method of choice for confirming this diagnosis. EWSR1 gene translocation can be identified in a number of different tumors including: 1) primitive neuroectodermal tumor (PNET/Ewing sarcoma) with t(11;22)(q24;q12) involving the EWSR1/Fli-1 as well as other EWSR1 variant translocations, 2) desmoplastic small round cell tumors (DSRCT) with t(11;22)(p13;q12) involving EWSR1/WT-1, 3) clear cell sarcoma (CCS), detecting t(12;22)(q13;q12) involving EWSR1/ATF1, and 4) extraskeletal myxoid chondrosarcomas (EMCs with t(9;22)(q22;q11-12) involving EWSR1/CHN. This assay is therefore of use when these tumors are being considered in a tumor differential. Probe type: Dual color breakapart
Organ: Soft Tissue
Disease State: Small, Blue, Round Cell Tumors, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Idiopathic hypereosinophilic syndrome (HES), or primary eosinophilia, is a chronic and typically slowly progressive disease that eventually results in organ damage. Several molecular mechanisms have been identified, including FIP1L1-PDGFRα and rearrangements of PDGFRβ and FGFR1. The presence of any of these abnormalities is associated with positive response to imatinib mesylate (Gleevec) therapy. While molecularly defined eosinophilias are relatively rare, up to one-quarter of HES patients have been shown to harbor one of these mutations. In these patients, imatinib therapy improves 5-year survival rates to from ~75% to 90-95% and reduces rates of progression from 50% down to less than 1%.
Organ: Blood/Bone Marrow
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374 x3. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Estrogen receptor alpha, a prognostic and predictive marker in breast cancer. Antibodies to ER can also be employed as part of a panel of antibodies in the identification of the primary site of carcinomas presenting as metastases. Subcellular Localization: Nuclear
Organ: Breast, OB/GYN, Pituitary, Hormones
Disease State: Carcinomas of Unknown Primary, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360 or 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: This assay uses pyrosequencing technology to detect clinically relevant mutations in KRAS codons 59, 61, 117 and 146; and in NRAS codons 12, 13, 59, 61, 117, and 146. See KRAS cobas® IVD (the Roche cobas® KRAS Mutation Test) for testing to detect the most common missense point mutations in codon 12 and 13 of KRAS exon 2. RAS proteins are involved in the EGFR signal transduction pathway. Mutated RAS protein is constitutively activated and tumors carrying these activating mutations have been shown to be resistant to anti-EGFR directed therapy. According to joint guidelines recently issued by ASCP, CAP, AMP and ASCO (see reference below), all patients with colorectal carcinoma being considered for anti-EGFR therapy must undergo RAS mutation testing to determine eligibility. RAS mutation analysis should include KRAS codons 12 and 13 (evaluated by the FDA-approved cobas assay; see KRAS cobas IVD) as well as “extended” RAS testing targeting KRAS codons 59, 61, 117, and 146; and NRAS codons 12, 13, 59, 61, 117, and 146. For colorectal carcinoma patients, PhenoPath recommends ordering RAS mutation testing in a reflexive manner, starting with this FDA-approved cobas® KRAS Mutation Test to test for KRAS exon 2 mutations, followed by extended RAS mutation testing if a KRAS exon 2 mutation is not detected (see Extended RAS Panel). REFERENCE: Sepulveda AR, et al. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology. J Mol Diagn 2017 19(2):187225.
Organ: Colon & Other GI
Disease State:
Turnaround Time: Within 5-8 business days of receipt
Schedule: Thursday
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): 81275, 81276; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Translocations that disrupt the fibroblast growth factor receptor-1 (FGFR1) gene are associated with a disease known as 8p11 myeloproliferative syndrome (EMS)/stem cell leukemia-lymphoma syndrome. This syndrome is characterized by myeloid hyperplasia that rapidly transforms to acute myelogenous leukemia and/or lymphoma within a year of the original diagnosis. In the “stem cell” myeloproliferative disorders, a mutation in the pluripotent hematopoietic progenitor results in a spectrum of diseases including T- or B-cell lymphoblastic lymphoma, bone marrow myeloid hyperplasia, and eosinophilia. These poor prognostic disorders are related to recurrent breakpoints on chromosome 8p11 that involve translocation of the FGFR1 gene. Tyrosine kinase fusions involving FGFR1 exhibit an aggressive and more variable sensitivity to current tyrosine kinase inhibitors, like imatinib, so in most cases long-term disease-free survival may only be obtainable with allogeneic hematopoietic stem cell transplantation.
Organ: Blood/Bone Marrow
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: A non-lineage-specific nuclear transcription factor expressed in normal mature B cells at several stages of development, and in a variety of non-Hodgkin lymphomas, but not in Hodgkin lymphomas.  FOXP1 is used as part of a panel of markers in immunohistochemical distinction of germinal center-derived diffuse large B cell lymphoma (DLBCL) from non-germinal center-derived DLBCL. Subcellular Localization: Nuclear
Organ: Genitourinary, Testis, Ovary
Disease State: Diffuse Large B Cell Lymphoma, Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The main clinical indication for FOXP3 IHC is expected to be immunophenotyping of tumor infiltrating lymphocytes (TILs) in human tumors. However, unforeseen clinical indications cannot be excluded. FOXP3 is a relatively specific marker of regulatory T cells (Tregs) which normally function to limit T cell-driven immune responses. Tregs are also involved in the immune evasion mechanisms promoted by cancer. Studies on several types of cancer suggested that high levels of Treg infiltration of the tumor bed are associated with poor clinical outcome (Martin F et al. 2010. Oncogene). In addition to FOXP3 expression in the tissues noted below, FOXP3 may be seen in the tumor infiltrating T cells in any type of human tomor. Subcellular Localization: Nuclear
Organ: Blood/Bone Marrow, Lymph Node / Spleen, Thymus (Mediastinal Mass)
Disease State: T Cell Non-Hodgkin Lymphoma (not otherwise classified)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Low-grade fibromyxoid sarcoma (LGFMS) is an indolent, late-metastasizing malignant soft-tissue tumor that is often mistaken for either benign or more malignant tumor types. Rearrangement of the FUS gene has been seen in these tumors, and can be used to aid in diagnosis. The FUS (fused in sarcoma) Breakapart probe is designed to detect rearrangement of the FUS gene on the short arm of chromosome 16 (16p11). The FUS gene encodes a multi-functional protein involved in, among other things, transcriptional activation and RNA binding. It is a member of the TET family of proteins that also includes EWS.
Organ: Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Fascin, a 55 kD actin-bundling protein. Fascin expression can be employed in the distinction of anaplastic large cell lymphoma (fascin-negative) from Hodgkin lymphoma (fascin-positive). Subcellular Localization: Cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This assay includes one tube with a cytoplasmic bcl-2 antibody and a second with an isotype control, and is added on to the workup virtually all CD10+ mature B cell lymphomas. Assessment of cytoplasmic bcl-2 allows distinction of BL (bcl-2 negative, and usually strongly CD38+) from other follicle center-derived B cell lymphomas usually bcl-2-positive, with highly variable CD38). Since CD11c is almost never expressed in FL or BL, if one detects a CD10+/CD11c+ B cell neoplasm, one should strongly consider CD10+ hairy cell leukemia, which is reported to represent ~15% of classic hairy cell leukemia. This tube includes antibodies to CD45, bcl-2, CD10, CD19, CD5, CD20, CD11c, and CD38.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Burkitt's Lymphoma, Follicular Lymphoma, Follicular Dendritic Cell Sarcoma
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x8. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This four-tube assay is designed to detect virtually any hematolymphoid neoplasm in the blood or bone marrow and includes all 24 of the consensus antigens recommended for this purpose at the 2006 Bethesda Consensus Meeting on Clinical Flow Cytometry (Cytometry B Clin Cytom 72B: S14-S22, 2007). This panel includes the previously mentioned mature B cell and mature T cell tubes, and also includes two tubes targeted at myeloid blasts and maturing granulocytes and monocytes. In addition to the 15 antigens present in the B and T cell tubes, the two myeloid tubes enable evaluation of 12 additional antigens: CD11b, CD15, CD33, CD117, HLA-DR, CD71, CD36, CD64, CD13, CD14, CD123, and CD16. Potential add-on tubes include: • Myeloid 4 add-on tube • Myeloid 5 add-on tube • Cytoplasmic lineage add-on tubes • Paroxysmal nocturnal hemoglobinuria (PNH) tubes • Rule out mastocytosis tubes • B-ALL add-on tube • T-ALL add-on tube
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL), Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML), Paroxysmal Nocturnal Hemoglobinuria (PNH), Blastic Plasmacytoid Dendritic Cell Neoplasm, Langerhans Cell Histiocytosis, Mastocytosis, Myelodysplastic Syndromes
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88184 x 1, 88185 x 26, 88189 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: GATA-3 is a zinc finger nuclear transcription factor that is a highly sensitive marker of carcinomas primary to the bladder and breast. GATA-3 is also expressed in a subset of squamous cell carcinomas, skin adnexal tumors, mesotheliomas, and salivary gland tumors, among others (Miettinen M et al. AJSP 38:13-22, 2014).
Organ: Breast, Genitourinary
Disease State: Carcinomas of Unknown Primary, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Breast carcinoma, sweat gland carcinoma, and a subset of salivary gland carcinoma. Can also be present in 10% of primary lung adenocarcinoma. Subcellular Localization: Cytoplasmic, granular
Organ: Breast
Disease State: Carcinomas of Unknown Primary, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: GCET1, a cytoplasmic protein that is relatively specific for normal germinal center B cells and germinal center-derived B cell neoplasms, including follicular lymphoma, Burkitt lymphoma, a subset of diffuse large B cell lymphoma (DLBCL), and nodular lymphocyte predominant Hodgkin lymphoma. GCET is also used as part of a panel of markers in immunohistochemical distinction of germinal center-derived DLBCL from non-germinal center-derived DLBCL. Subcellular Localization: Cytoplasmic (secretory), granular, with frequent Golgi staining
Organ: Genitourinary, Testis, Ovary
Disease State: Diffuse Large B Cell Lymphoma, Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Glial fibrillary acidic protein (GFAP), an intermediate filament protein expressed almost exclusively in glial cells and tumors of the central nervous system. GFAP is also expressed, however, in a restricted subset of epithelial tumors, including salivary gland pleomorphic adenomas. Subcellular Localization: Cytoplasmic
Organ: Brain/CNS
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Galectin-3, a member of the lectin family, is upregulated in thyroid carcinoma, and can be employed as part of a panel of markers to assist in the distinction of thyroid carcinomas from adenomas. In the latter setting, galectin-3 has been demonstrated to be strongly and diffusely positive in papillary thyroid carcinomas, but weakly and focally positive in adenomas. Subcellular Localization: Nuclear and cytoplasmic
Organ: Thyroid
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Gastrin is a hormone expressed by G cells of the stomach antrum, but also expressed in a subset of pancreatic islet cell tumors (gastrinomas). Subcellular Localization: Cytoplasmic
Organ: Pancreas, Hormones
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Glucagon, a hormone expressed in the alpha cells of the pancreatic islet, as well a subset of pancreatic islet cell tumors (glucagonomas). Subcellular Localization: Cytoplasmic
Organ: Pancreas, Hormones
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Glycophorin A, a marker of erythrocytes and erythroid differentiation in myeloid processes. Subcellular Localization: Membranous
Organ:
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Glypican-3, a heparan sulfate proteoglycan that is a reliable marker for hepatocellular carcinoma, with a sensitivity and specificity exceeding both alpha-fetoprotein and HepPar1. Glypican-3 is also a marker of yolk sac tumors in the context of other germ cell neoplasms. Subcellular Localization: Cytoplasmic, granular
Organ: OB/GYN, Genitourinary, Liver, Testis, Ovary
Disease State: Germ Cell Tumors, Hepatocellular Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Granzyme B is a useful biomarker for cytotoxic T-lymphocytes and natural killer cells, and may aid in differentiating between tumors arising from these cell types and tumors arising from other hematolymphoid cell types. Granzyme B is a serine protease that is the main component in granule-mediated targeted cell lysis. Cytotoxic T-lymphocytes (CTL) and Natural-Killer (NK) cells store granzyme B-containing granules in their cytoplasm and release them during CTL-mediated targeted cell lysis (the ‘cell-mediated’ component of the immune response). After release from the CTL, granzyme B binds its receptor on the target cell, is endocytosed, and remains in the endocytic vesicle until released by perforin. Once released into the target cell cytoplasm, granzyme B can affect cell death via two pathways: 1) initiating a caspase cascade that leads to rapid DNA fragmentation of the target cell (apoptosis) or 2) mediating the release of cytochrome c from the mitochondria, which leads to cell death via necrosis.
Organ: Skin & Mucosa, Blood/Bone Marrow, Lymph Node / Spleen, Soft Tissue
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), NK/T Cell Lymphoma, Nasal Type, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88312. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: This antibody is used for the identification of malignant peripheral nerve sheet tumors (MPNST), approximately 50% of which show complete loss of expression of this nuclear protein. This loss of expression is highly specific to MPNST, and can help distinguish it from other sarcomas and spindle cell melanomas. Subcellular Localization: Nuclear (Loss of expression)
Organ: Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule:
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A protein originally described as a positive marker of mesotheliomas, but other markers are currently employed for that purpose (e.g., calretinin, WT-1, podoplanin, cytokeratin 5, etc.) HMBE-1, however, has been found to be useful as part of a panel of markers in the distinction of thyroid carcinomas from adenomas. Subcellular Localization: Membranous
Organ: Thyroid
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The hormone produced by trophoblasts. It is useful for the identification of cells manifesting trophoblastic differentiation, e.g., in germ cell tumors. Subcellular Localization: Cytoplasmic
Organ: OB/GYN, Genitourinary, Hormones, Testis, Ovary
Disease State: Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The HER2 gene product, which is overexpressed, almost always as a consequence of HER2 gene amplification, in a subset of breast cancers, gastric adenocarcinomas, and other tumors. It is a prognostic and predictive marker, and the target of trastuzumab and other HER2 targeted therapies. Subcellular Localization: Membranous
Organ: Breast, Colon & Other GI
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: The Abbott Molecular PathVysion HER2 (ERBB2) DNA Probe Kit is an FDA-approved kit used for evaluation of HER2 (ERBB2) gene amplification in breast cancer. The HER2 (ERBB2) oncogene is a member of the epidermal growth factor receptor family and has been found to be altered in approximately 20% of breast cancers. The PathVysion HER2 (ERBB2) DNA Probe Kit is a dual color probe kit that contains one probe (SpectrumOrange) specific for the HER2 (ERBB2) gene, and a second probe (SpectrumGreen) specific for chromosome 17. The underlying alteration is an amplification of the gene, resulting in more than the usual 2 copies of HER2 (ERBB2) (one on each copy of chromosome 17) typically present in normal breast epithelium and the majority of breast cancers without HER2 (ERBB2) alterations. Gene amplification is defined as a ratio of HER2 (ERBB2) to chromosome 17 signals of >2.2. Amplification of the HER2 (ERBB2) gene is almost always associated with overexpression of the HER2 (ERBB2) protein, as assessed by immunohistochemistry (IHC). PhenoPath Laboratories has accumulated HER2 (ERBB2) protein IHC and FISH data in over 4,000 breast cancer patients over the past several years. These studies demonstrate the positive predictive value of a 3+ IHC study for HER2 (ERBB2) amplification by FISH is 94%, and the negative predictive value for a negative IHC study (i.e., a score of 0 or 1+) for non-amplification by FISH is 96%. A disproportionate fraction of the cases with discordant IHC and FISH results are cases of aneuploid tumors showing excess copies of chromosome 17, which may lead to overexpression of the protein, but without concomitant gene amplification (as the number of copies of the HER2 (ERBB2) gene might not be more than two-fold that of chromosome 17). We recommend the use of IHC as an initial screen for HER2 (ERBB2) status, with FISH studies performed on cases that show 2+ levels of immunostaining: i.e., cases indicated as showing an "indeterminate" HER2 (ERBB2) status by IHC. HER2 (ERBB2) overexpression/gene amplification is an independent prognostic marker of adverse clinical outcome in breast cancer, and can predict response to doxorubicin (Adriamycin)-based adjuvant chemotherapy, as well as resistance to tamoxifen, even in the setting of ER/PR expression. Furthermore, HER2 (ERBB2) status also predicts response to immunotherapy with a "humanized" monoclonal antibody, trastuzumab (Herceptin) directed at the HER2 (ERBB2) protein. Probe type: Dual color enumeration
Organ: Lung, Breast, Liver, Colon & Other GI, Lymph Node / Spleen
Disease State: Adenocarcinoma, Breast Cancer, Metastatic Carcinoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested AND HER2 IHC slide (if no HER2 IHC slide is available, PhenoPath will perform and bill for the IHC, as needed, to interpret the HER2 FISH)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: HGAL - also known as GCET2, GCAT2, and GCSAM – is a cytoplasmic protein expressed by benign and neoplastic follicle center (germinal center)-derived B cells. As part of a panel of IHC antibodies, the HGAL antibody is useful to distinguish follicle center-derived B cell non-Hodgkin lymphoma (B-NHL) from other B cell proliferations. Subcellular Localization: Cytoplasmic
Organ: Lymph Node / Spleen
Disease State: Burkitt's Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: HHV8 latent nuclear antigen, or LANA, a nuclear protein expressed by cells infected with HHV8. It is expressed in both Kaposi's sarcoma as well as HHV8-associated lymphoproliferative disorders, including primary effusion lymphomas and multicentric Castleman's disease. Subcellular Localization: Nuclear positivity with speckled staining pattern
Organ:
Disease State: Identification of Organisms, HIV-Associated Lymphoma, Post-Transplant Lymphoproliferative Disorders
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: HLA-DR (class II histocompatibility antigen). Expressed in lymphomas and leukemias, both myeloid and lymphoid. Examples include acute myeloid leukemias (AML), and chronic myelomonocytic leukemias (CMML). Expression varies in each neoplasm, depending on various factors, including cell maturity and differentiation. HLA-DR has been shown to be consistently expressed in most AMLs of non-M3 (Acute promyelocytic or APL) type, and has been shown to be helpful in differentiating myeloblastic from promyelocytic variants. Subcellular Localization: Membranous
Organ:
Disease State: Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The gp100 protein, found in premelanosomes.  As such, HMB-45 is a highly sensitive and specific marker of melanoma, particularly in the metastatic setting.  The epitope targeted by HMB-45 behaves as an ‘oncofetal’ antigen that is not expressed in normal, resting melanocytes but is present in reactive and neoplastic melanocytic processes. Furthermore, as a marker of a premelanosomal protein, it is also an excellent marker of clear cell sarcoma as well as PEComas. Subcellular Localization: Cytoplasmic, granular
Organ: Skin & Mucosa
Disease State: Large Cell Undifferentiated Malignant Neoplams, Spindle Cell Tumors / Sarcoma Subtyping, Melanoma, Clear Cell Sarcoma, PEComas
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies Herpes simplex viruses I and II-infected cells. Subcellular Localization: Nuclear and cytoplasmic
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: An uncharacterized antigen present in >97% of cases of hairy cell leukemia. Other tumors positive include a high fraction of cases of splenic lymphomas with villous lymphocytes, and a smaller fraction of high grade B cell lymphomas (e.g., immunoblastic). The antibody shows strong positive staining of about 35% of cases of high-grade B cell lymphomas, e.g. centroblastic and immunoblastic types. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Hairy Cell Leukemia
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube is particularly useful to look for hairy cell leukemia, and to distinguish this entity from marginal zone lymphoma and other lymphomas that can have some overlapping immunophenotypes. The tube contains antibodies to CD45, CD103, CD22, CD25, CD5, CD11c, CD19, and CD38.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: B Cell NHL with Plasmacytoid Differentiation, Hairy Cell Leukemia, Marginal Zone/MALT Lymphoma, Lymphoplasmacytic Lymphoma
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x8. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Helicobacter pylori organisms in gastric mucosa. Subcellular Localization: N/A
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Hemoglobin A, a protein expressed in progressively greater amounts in erythroid cells after the basophilic erythroblast stage, reaching a maximum level in mature erythrocytes. Subcellular Localization: Membranous
Organ:
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Carbamoyl phosphate synthetase 1, a mitochondrial protein present in hepatocytes and hepatocellular carcinoma. When used as part of a panel of other markers, HepPar1 is useful in distinguishing hepatocellular carcinoma from cholangiocarcinoma and metastatic carcinomas to the liver. However, carbamoyl phosphate synthetase 1 is also expressed in a subset of gastric carcinomas as well as ‘hepatoid’ carcinomas of various organs. Subcellular Localization: Cytoplasmic, granular
Organ: Liver
Disease State: Carcinomas of Unknown Primary, Hepatocellular Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Hepatitis B infected cells in the liver and other sites. Subcellular Localization: Nuclear
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Hepatitis B infected cells in the liver and other sites. Subcellular Localization: Cytoplasm
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: p57kip2 is a paternally imprinted, maternally expressed gene that is not expressed in the cytotrophoblasts of complete moles (which are of paternal origin only). It is positive in both partial moles and normal hydropic villi. In addition, complete moles are characterized by high Ki-67-defined proliferative index in the cytotrophoblasts.  Further distinction of partial moles from hydropic normal villi can be made by identifying the triploid nature of incomplete moles. This can be accomplished by fluorescence in situ hybridization studies using a chromosome 17 probe to ascertain ploidy. It should be noted that these mole ploidy studies are best interpreted in conjunction with morphology for the evaluation of both complete and partial moles.
Organ: OB/GYN
Disease State: Molar Pregnancy
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested plus 2 unstained slides cut at 6µm
CPT Code(s): 88342; 88360; 88367; 88323. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88367; 88373/88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: Isocitrate dehydrogenase 1, an enzyme that participates in the citric acid cycle, and is mutated in a high fraction of gliomas and oligodendrogliomas, particularly in grade II and grade III neoplasms. In these tumors, the overwhelming majority show a point mutation on codon 132 (R132H). The availability of a monoclonal antibody specific for the mutated IDH1, which does not cross react with the native protein, has provided an immunohistochemical tool that can be used to positively identify these tumors. Furthermore, because IDH mutations do not occur in reactive gliosis, the latter can often be separated from diffuse gliomas, which are usually positive for the mutation (and hence positive by IHC). Subcellular Localization: Nuclear and cytoplasmic
Organ: Brain/CNS
Disease State: Oligodendroglioma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This sensitive breakapart FISH assay detects any translocation involving the IGH gene, although it does not identify the gene with which it is partnered. Many different translocation partners for the IGH gene have been identified in human B cell lymphoma including BCL2 in follicular lymphomas resulting in the t(14;18), CCND1 in mantle cell lymphoma resulting in the t(11;14), MYC in Burkitt's lymphoma resulting in the t(8;14), MALT1 in malt lymphoma resulting in the t(14;18), and CMAF and FGFR3 in myeloma reulting in the t(14;16) and t(4;14), respectively. IGH translocations are also frequently seen in diffuse large B cell lymphoma (DLBCL). Probe type: Dual color breakapart
Organ: Skin & Mucosa, Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone/MALT Lymphoma, Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: This is an oncofetal RNA binding protein normally expressed in embryonal tissues and re-expressed in a significant fraction of neoplastic cells, but generally not expressed in normal adult tissues. IMP3 may be helpful in the identification of malignant tumors. Subcellular localization: Cytoplasmic
Organ: Lung, OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State: Melanoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The gene product of the INI-1 gene, also referred to as BAF47. This is a tumor suppressor gene, inactivation through mutation or other mechanism characterizes a unique subset of tumors that includes renal and extrarenal rhabdoid tumors, atypical teratoid/rhabdoid tumors of the central nervous system, distal and proximal variants of epithelioid sarcoma, as well as a subset of mesenchymal chondrosarcomas, epithelioid malignant peripheral nerve sheath tumors, and soft tissue myoepitheliomas. Loss of immunostaining is the characteristic feature of these tumors. Subcellular Localization: Nuclear
Organ: Brain/CNS
Disease State: Small, Blue, Round Cell Tumors, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: INPP4B encodes the inositol polyphosphate 4-phosatase type II, one of the enzymes involved in phosphatidylinositol signaling pathways. This antibody is useful as a diagnostic aid for basal like breast carcinomas, as the absence of expression of INPP4B, has been shown in our hands to have a 90% sensitivity and 80% specificity for basal-like breast carcinomas, which closely reflects the reported literature. INPP4B will be run in a panel with other antibodies used in the diagnosis of basal-like breast carcinomas, such as, Nestin, Keratin 5, and c-kit. Subcellular Localization: membranous and cytoplasmic
Organ: Breast
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The Kappa Clonality Assay is a multiplex fluorescent PCR assay based on the pan-European collaborative study (BIOMED-2). It is particularly useful when IgH clonality testing fails to identify a clonal rearrangement which can occur due to somatic hypermutation. Importantly, this test should be interpreted in the context of clinical, histologic, and immunophenotypic information and should not be used in isolation in the evaluation of possible B cell lymphoproliferative disorders. Clinical indications for the test include: • Any suspect B cell proliferation when morphology and immunophenotyping are not conclusive • Lymphoproliferations in immunodeficient patients • Evaluation of the clonal relationship between two B lymphoid malignancies in one patient or discrimination between a relapse and a second malignancy • Occasionally, staging of B cell lymphomas • Aid in minimum residual disease detection Type: PCR/Capillary Electrophoresis, Qualitative
Organ: Skin & Mucosa, Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified)
Turnaround Time: Within 3-5 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 81264; 88381 may apply; G0452 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Immunofluorescence
Clinical Significance: Identifies: IgA localization by direct immunofluorescence is useful in the subclassification of bullous and other skin disorders, particularly when employed as part of a panel of FITC-conjugated antibodies, including those to IgG, IgM and C3. IgA deposits in the skin are particularly important in the identification of dermatitis herpetiformis and Henoch Schoenlein purpura. Subcellular Localization: Extracellular
Organ: Skin & Mucosa
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: Skin biopsy in Michel's (aka Zeuss) fixative, with or without patient serum
CPT Code(s): 88346 or 88350. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: IgA-positive plasma cells and plasma cell neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: IgD, or immunoglobulin D heavy chain, a cytoplasmic protein strongly expressed by naive/mantle zone B cells and a small subset of plasma cells, and weakly expressed by germinal center B cells. A subset of B cell non-Hodgkin lymphomas, generally of germinal center or pre-germinal center origin, express IgD. Subcellular Localization: Membranous
Organ:
Disease State: Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: IgG positive plasma cells and plasma cell neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Immunofluorescence
Clinical Significance: Identifies: IgG localization by direct immunofluorescence is useful in the subclassification of bullous and other skin disorders, particularly when employed as part of a panel of FITC-conjugated antibodies, including those to C3, IgM and IgA. IgG deposits in the skin, with unique distributions, characterize a number of dermatologic disorders, including bullous pemphigoid, pemphigus, lupus, etc. Subcellular Localization: Extracellular
Organ: Skin & Mucosa
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: Skin biopsy in Michel's (aka Zeuss) fixative, with or without patient serum
CPT Code(s): 88346 or 88350. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: This clone identifies IgG4 positive plasma cells, which are increased in IgG4-related sclerosing disease. The immunohistochemical evaluation for IgG4-related disease (IRD) is commonly based on the percentage of IgG4-specific plasma cells among the total IgG-positive plasma cells (usually over 40%, or over 50 IgG4+ plasma cells per 400x field, in this disease, see reference). Therefore, PhenoPath's assay employs antibodies to both IgG4 and total IgG. In some cases, antibodies to CD38 or IgA may also be employed, particularly when total IgG+ plasma cells appear to represent a minority of the total plasma cells, as is common in the gastrointestinal tract. Our pathologists are happy to answer questions concerning interpretation of IgG4 or PhenoPath's testing policy. Ref: Mod Pathol 25:1181-92, 2012 Subcellular Localization: Cytoplasmic
Organ: Colon & Other GI, Thyroid, Soft Tissue, Salivary gland
Disease State: Benign/reactive sclerosing lesion
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • Minimum of 5 unstained slides cut at 4µm
CPT Code(s): 88360 and 88342 and/or 88341 x number of additional antibodies performed. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The IgH Clonality Assay is a multiplex fluorescent PCR assay based on the pan-European collaborative study (BIOMED-2). This assay uses the framework 1, 2, and 3 primer sets (FR1, FR2, and FR3) utilized by BIOMED-2 for the analysis of IgH gene rearrangements. Importantly, this test should be interpreted in the context of clinical, histologic, and immunophenotypic information and should not be used in isolation in the evaluation of possible B cell lymphoproliferative disorders. Clinical indications for the test include: • Any suspect B cell proliferation when morphology and immunophenotyping are not conclusive • Lymphoproliferations in immunodeficient patients • Evaluation of the clonal relationship between two B lymphoid malignancies in one patient or discrimination between a relapse and a second malignancy • Occasionally, staging of B cell lymphomas • Aid in minimum residual disease detection Type: PCR/Capillary Electrophoresis, Qualitative
Organ: Skin & Mucosa, Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), B Cell NHL with Plasmacytoid Differentiation, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone/MALT Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma, Post-Transplant Lymphoproliferative Disorders, Plasma Cell Myeloma/Neoplasm, Lymphoplasmacytic Lymphoma
Turnaround Time: Within 3-5 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 81261; 88381 may apply; G0452 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Immunofluorescence
Clinical Significance: Identifies: IgM localization by direct immunofluorescence is useful in the subclassification of bullous and other skin disorders, particularly when employed as part of a panel of FITC-conjugated antibodies, including those to C3, IgG and IgA. IgM deposits in the skin, with unique patterns, are characteristic of specific dermatologic disorders, including vasculitis, lupus, and others. Subcellular Localization: Extracellular
Organ: Skin & Mucosa
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: Skin biopsy in Michel's (aka Zeuss) fixative, with or without patient serum
CPT Code(s): 88346 or 88350 . The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: IgM positive plasma cells and plasma cell neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: Inhibin-alpha, a hormone component that joins either the beta A or beta B subunit to form a pituitary FSH secretion inhibitor. It is expressed by, and can be used as a marker of, granulosa cells and granulosa cell and other sex cord stromal tumors, as well as adrenal cortical cells and tumors. Subcellular Localization: Cytoplasmic
Organ: OB/GYN, Genitourinary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Specimen MUST be received within 48 hrs of collection • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: PCR
Clinical Significance: This real time PCR test detects the exon 14 JAK2 V617F mutation, which is identified in the great majority of polycythemia vera (PV) cases as well as in other non-CML myeoloproliferative disorders. The JAK2 V617F mutation causes a constitutive activation of the JAK2 tyrosine kinase, which is believed to confer erythropoietin hypersensitivity and erythropoietin-independent survival of the myeloid stem cell. Additionally, these diseases may also transform into acute myeloid leukemia. Thus, detection of the JAK2 (V617F) mutation provides important confirmation of non-CML MPD. Type: Real-Time PCR, Qualitative
Organ: Skin & Mucosa, Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML)
Turnaround Time: Within 4-8 business days of receipt
Schedule: Wednesday
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 81270; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood: 5 ml in EDTA (purple top) • Bone marrow aspirate: 2 ml in EDTA (purple top Specimen must arrive within 5 days of collection
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or H&E and 5 unstained slides cut at 5 micron
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: PCR
Clinical Significance: This PCR assay uses the FDA-approved, Roche cobas® KRAS Mutation Test kit to detect the most common missense point mutations in codons 12 and 13 of KRAS exon 2. KRAS is a G-protein that is a key component of the EGFR signal transduction pathway. Mutated KRAS protein is constitutively activated and tumors carrying these activating mutations have been shown to be resistant to anti-EGFR directed therapy. Please note that current guidelines for colorectal carcinoma molecular testing recommend that patients being considered for anti-EGFR therapy must undergo RAS mutation testing to determine eligibility. According to joint guidelines recently issued by ASCP, CAP, AMP and ASCO (see reference below), all patients with colorectal carcinoma being considered for anti-EGFR therapy must undergo “extended” RAS mutation testing that includes the following mutations: KRAS codons 12 and 13 (exon 2), KRAS codons 59 and 61 (exon 3), KRAS codons 117 and 146 (exon 4), NRAS codons 12 and 13 (exon 2) NRAS codons 59 and 61 (exon 3), and NRAS codons 117 and 146 (exon 4). PhenoPath recommends ordering RAS mutation testing in a reflexive manner, starting with this FDA-approved cobas® KRAS Mutation Test to test for KRAS exon 2 mutations, followed by extended RAS mutation testing if a KRAS exon 2 mutation is not detected (see Extended RAS Panel). REFERENCE: Sepulveda AR, et al. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology. J Mol Diagn 2017 19(2):187225.
Organ: Colon & Other GI
Disease State:
Turnaround Time: Within 3-6 business days of receipt
Schedule: Tuesday
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): 81275; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Kappa and lambda immunoglobulin light chains, expressed by plasma cells and plasmacytoid lymphocytes. Also expressed, but less reliably detected, on B cells with small amounts of cytoplasm. The ratio of kappa-positive to lambda-positive cells in normal/polyclonal B cell and plasma cell populations typically ranges from 1:1 to 2:1. Marked increases in this ratio suggest kappa light chain-restriction, while marked decreases in the ratio (significantly < 1) suggest lambda light chain-restriction. Light chain restriction is conventionally used as a surrogate for clonality among B cell neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Amyloid Type Analysis, B Cell NHL with Plasmacytoid Differentiation, HIV-Associated Lymphoma, Post-Transplant Lymphoproliferative Disorders
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: CISH
Clinical Significance: Kappa and lambda immunoglobulin light chains are expressed by plasma cells and plasmacytoid lymphocytes. They are also expressed, but less reliably detected, on B cells with weak cytoplasmic staining. However, immunoglobulin are also a major component of serum, leading to (in many tissue types) high background/non-specific staining which may obscure the detection/observation of light chain restriction among B lineage cells. This non-specific staining also impedes the assessment of light chain skewing in non-neoplastic populations. As all proteins are translated from mRNA, detection of mRNA transcripts can be a useful surrogate for protein expression and therefore in-situ hybridization for kappa and lambda mRNA transcripts can be used to determine the light chain restriction status for plasma cell and plasmacytoid B cell populations. Subcellular Localization: Cytoplasmic
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Amyloid Type Analysis, B Cell NHL with Plasmacytoid Differentiation, HIV-Associated Lymphoma, Post-Transplant Lymphoproliferative Disorders, Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88365 or 88364. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a subset of epithelia and carcinomas. CK17 expression can help identify primary carcinomas of the pancreatobiliary tract, distinguishing them from ovarian mucinous adenocarcinomas and carcinomas of the stomach, among others. Subcellular Localization: Cytoplasmic
Organ: Pancreas, Ovary
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a subset of epithelia and carcinomas. Published studies suggest that CK19 expression, along with expression of galectin-3 and HBME-1, is useful in differentiating papillary carcinomas of the thyroid from benign thyroid lesions. Subcellular Localization: Cytoplasmic
Organ: Thyroid
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a subset of carcinomas. Co-analysis of expression of cytokeratin 7 can be helpful in the identification of the primary site of carcinomas presenting at metastatic sites. CK20 is also a marker of Merkel cell tumors, usually displaying a dot-like perinuclear pattern of expression. Subcellular Localization: Cytoplasmic
Organ: Colon & Other GI
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies squamous and transitional cell epithelia, mesothelium, ductal epithelium and their corresponding carcinomas. In complex epithelia such as normal prostate glands, the basal cells in most cases express CK5. CK5 expression can also be seen in some nonsquamous carcinomas, e.g., pancreatic adenocarcinoma. Subcellular Localization: Cytoplasmic
Organ: Lung, Breast, Genitourinary, Prostate
Disease State: Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Spindle Cell Tumors / Sarcoma Subtyping, Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC), Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a subset of carcinomas. Co-analysis with expression of cytokeratin 20 can be helpful in the identification of the primary site of carcinomas presenting at metastatic sites. Subcellular Localization: Cytoplasmic
Organ: Lung, Genitourinary, Colon & Other GI
Disease State: Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies many members of the cytokeratin group of cytoskeletal proteins. AE1/AE3 is a cocktail of two monoclonal antibodies to non-overlapping groups of cytokeratins that are expressed in a wide range of epithelial tumors. Cytokeratin expression can identify carcinomas in the context of undifferentiated malignancies, although cytokeratins (generally at lower levels) can be expressed in a restricted subset of non-epithelial tumors (e.g., melanoma, smooth muscle tumors, etc.) Subcellular Localization: Cytoplasmic
Organ:
Disease State: Large Cell Undifferentiated Malignant Neoplams
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies many members of the cytokeratin group of cytoskeletal proteins. Very similar pattern of reactivity compared with the AE1/AE3 antibody cocktail. However, as a single monoclonal antibody, it has advantages over the AE1/AE3 antibody cocktail. It can thus be employed to identify carcinomas in the context of undifferentiated malignancies. Cytokeratin expression can identify carcinomas in the context of undifferentiated malignancies, although cytokeratins (generally at lower levels) can be expressed in a restricted subset of non-epithelial tumors (e.g., melanoma, smooth muscle tumors, etc.). Subcellular Localization: Cytoplasmic
Organ: Lung, Genitourinary, Testis, Ovary
Disease State: Small, Blue, Round Cell Tumors, Large Cell Undifferentiated Malignant Neoplams, Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Spindle Cell Tumors / Sarcoma Subtyping, Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies "high molecular weight" cytokeratins. It is an excellent marker of squamous differentiation, as well as a marker of the outer cell layer in prostatic glands, which is absent in carcinoma. Subcellular Localization: Cytoplasmic
Organ: Genitourinary, Prostate
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The Ki-67 defined antigen, a nuclear protein expressed in proliferating (i.e., non-G0) cells. Used as a quantitative marker of cell proliferation in tumors. The SP6 clone is more robust than MIB-1 and is generally employed in the context of decalcified bone marrow specimens. Subcellular Localization: Nuclear
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360 (reference. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The Ki-67 defined antigen, a nuclear protein expressed in proliferating (i.e., non-G0) cells. Used as a quantitative marker of cell proliferation in tumors. Subcellular Localization: Nuclear
Organ: Lung, Breast, OB/GYN
Disease State: Molar Pregnancy, Non Small Cell Lung Carcinoma (NSCLC), Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Lymphoid enhancer-binding factor 1, a nuclear transcription factor in the WNT/beta-catenin signaling pathway that is normally expressed in T cells and immature pro-B cells, but not in normal mature B cells.  LEF-1 is aberrantly expressed in virtually all cases of CLL/SLL, but is almost always negative in mantle cell lymphoma, marginal zone lymphoma, and low-grade follicular lymphoma, and therefore may be helpful in distinguishing CLL/SLL from mantle cell lymphoma. Subcellular Localization: Nuclear
Organ:
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A cysteine-rich protein that also plays a central and crucial role in hematopoietic development. In the setting of diffuse large B-cell lymphomas (DLBCLs), LMO2 has high sensitivity in differentiating between germinal center B-cell (GCB) DLBCLs and non-GCB DLBCLs. Based on the recently published Tally Method algorithm, LMO2 will be used in a panel, along with CD10, GCET1, MUM1, and FoxP1, to help distinguish between GCB versus non-GCB origin among DLBCLs. Subcellular Localization: Nuclear
Organ:
Disease State: Diffuse Large B Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Kappa and lambda immunoglobulin light chains, expressed by plasma cells and plasmacytoid lymphocytes. Also expressed, but less reliably detected, on B cells with small amounts of cytoplasm. The ratio of kappa-positive to lambda-positive cells in normal/polyclonal B cell and plasma cell populations typically ranges from 1:1 to 2:1. Marked increases in this ratio suggest kappa light chain-restriction, while marked decreases in the ratio (significantly < 1) suggest lambda light chain-restriction. Light chain restriction is conventionally used as a surrogate for clonality among B cell neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Amyloid Type Analysis, B Cell NHL with Plasmacytoid Differentiation, HIV-Associated Lymphoma, Post-Transplant Lymphoproliferative Disorders
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: CISH
Clinical Significance: Kappa and lambda immunoglobulin light chains are expressed by plasma cells and plasmacytoid lymphocytes. They are also expressed, but less reliably detected, on B cells with weak cytoplasmic staining. However, immunoglobulin are also a major component of serum, leading to (in many tissue types) high background/non-specific staining which may obscure the detection/observation of light chain restriction among B lineage cells. This non-specific staining also impedes the assessment of light chain skewing in non-neoplastic populations. As all proteins are translated from mRNA, detection of mRNA transcripts can be a useful surrogate for protein expression and therefore in-situ hybridization for kappa and lambda mRNA transcripts can be used to determine the light chain restriction status for plasma cell and plasmacytoid B cell populations. Subcellular Localization: Cytoplasmic
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Amyloid Type Analysis, B Cell NHL with Plasmacytoid Differentiation, HIV-Associated Lymphoma, Post-Transplant Lymphoproliferative Disorders, Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88365 or 88364. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Langerin, a protein encoded by the CD207 gene, which is a transmembrane cell surface receptor produced by Langerhans cells and Langerhans cell neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Langerhans Cell Histiocytosis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This two-tube add-on is used when the population of interest shows large cell size by morphology and/or forward light scatter, and when evaluation of CD30 and CD25 expression is of interest. The base antibodies for these add-on tubes include CD45, CD52, CD30, CD3, CD25, and HLA-DR; additional T cell-associated antigens, such as CD5, CD4, and CD8, may be evaluated in this tube to aid in identification of the abnormal population.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x6. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule: Tuesday and Thursday
Specimen Requirements: Preferred Specimen(s): 5mL whole blood or bone marrow collected in an EDTA (lavender-top) tube Minimum Volume: 2 mL Transport at room temperature Specimen Stability: Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Reject Criteria: Gross hemolysis, frozen, clotted
CPT Code(s): 36787 (reference only; CPTs may vary)

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule: Tuesday and Thursday
Specimen Requirements: Preferred Specimen(s): 5mL whole blood or bone marrow collected in an EDTA (lavender-top) tube Minimum Volume: 2 mL Transport at room temperature Specimen Stability: Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Reject Criteria: Gross hemolysis, frozen, clotted
CPT Code(s): 36789 (reference only; CPTs may vary)

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule: Tuesday and Thursday
Specimen Requirements: Preferred Specimen(s): 5mL whole blood or bone marrow collected in an EDTA (lavender-top) tube Minimum Volume: 2 mL Transport at room temperature Specimen Stability: Room temperature: 14 days Refrigerated: 14 days Frozen: Unacceptable Reject Criteria: Gross hemolysis, frozen, clotted
CPT Code(s): 36788 (reference only; CPTs may vary)

Methodology: IHC
Clinical Significance: Identifies: A glycoside hydrolase also known as muraminidase that is a marker of granulocytes and granulocytic neoplasms. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This sensitive breakapart FISH assay detects any MALT gene rearrangement including the t(11;18) and the t(14;18). MALT1 gene rearrangements occur in a subset of extra-nodal marginal zone B cell lymphomas (MZBCL) and can aid in this diagnosis.
Organ: Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Marginal Zone/MALT Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: The MALT1 beakapart FISH assay is a sensitive test that detects gene rearrangements involving the MALT1 gene but does distinguish between the different MALT1 translocation partners that have been described. The main MALT1 translocations that occur in human MALT lymphomas include the t(11;18)(q21;q21)/API-2-MALT and t(14;18)(q32;q21)/IgH-MALT. Identification of a MALT1 rearrangement is of diagnostic use in atypical B cell proliferations when the diagnosis of MALT lymphoma is being considered. Probe type: Dual color breakapart
Organ: Skin & Mucosa, Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell NHL with Plasmacytoid Differentiation, Marginal Zone/MALT Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: In this reflexive panel a MALT1 breakapart FISH assay is performed. If negative, no more testing is performed. If positive, one additional FISH assay is performed to positively identify and confirm the presence of t(11;18), which is the most common MALT1 gene translocation that occurs in MZBCL.
Organ: Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Marginal Zone/MALT Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374x2. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: MART1 (Melan A), a sensitive and specific marker of melanoma. While its sensitivity is comparable to that of HMB45, MART1, in contrast, is also a marker of sex cord-stromal and adrenal cortical tumors. Subcellular Localization: Cytoplasmic
Organ: OB/GYN, Skin & Mucosa
Disease State: Melanoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: FISH evaluation for MDM2 amplification has been shown to be a useful tool in the diagnosis of lipomatous neoplasms; specifically, well-differentiated liposarcomas, atypical lipomatous tumors, and dedifferentiated liposarcomas containing cytogenetic alterations of the 12q13-15 region. MDM2 is a gene in this genomic region that is frequently amplified in these tumor types. In contrast, benign lipomas and lipocytic tumors as well as most other non-lipomatous sarcomas and mesenchymal neoplasms have been shown to be negative for MDM2 amplification. Testing for MDM2 amplification by FISH therefore aids in the pathologic differential diagnosis of lipomatous/dedifferentiated liposarcomas versus nonlipocytic sarcomas and mesenchymal neoplasms; specifically, when the histologic differential diagnosis is lipoma versus well-differentiated liposarcoma, the presence of MDM2 amplification would be in keeping with liposarcoma. Additionally, when the differential includes dedifferentiated liposarcoma versus sarcoma, NOS, as well as other sarcoma types, the presence of MDM2 amplification also suggests a lipocytic origin. Finally, non-amplified, but polysomic MDM2 and SE12 can be seen in cases of pleomorphic lipoma. Probe type: Dual color enumeration
Organ: Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: MDS represents a heterogeneous group of clonal myeloid stem cell disorders which are characterized not only by specific histologic changes typically seen in the bone marrow and peripheral blood, but also by specific chromosome abnormalities. The MDS FISH Panel offered at PhenoPath covers the most common MDS-associated chromosomal abnormalities and specifically detects the following: EGR1/5q31 deletion (5q-), monosomy 5, deletion 7q31, monosomy 7, deletion 20q12, and trisomy 8. The different chromosomal abnormalities have prognostic significance and generally can be divided into three prognostic groups: favorable, intermediate, and poor. Tumors manifesting deletion of 5q31, 20q12, and lacking any other genetic abnormalities constitute the favorable group; furthermore, patients with tumors manifesting 5q loss are eligible for Revlimid® (lenalidomide) therapy. Tumors with trisomy 8 and deletion 7q31 constitute the intermediate prognosis group and those with monosomy 5 or 7 represent the poor prognostic group.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML), Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374x2, 88367; 88373. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: MET is a 125k bp proto-oncogene receptor tyrosine kinase, known also as c-MET or hepatocyte growth factor receptor (HGFR). It has embryonic activity in epithelial cells, playing a role in the development of a variety of tissues and organs. In adults, MET expression is seen only in stem and progenitor cells. Mutation of MET is associated with a poor prognosis as it can trigger tumor growth, angiogenesis and metastasis. MET amplification has been observed in both non-small cell lung carcinomas (NSCLCs) and esophageal adenocarcinomas. The presence of MET amplification is associated with acquired resistance to certain tyrosine kinase inhibitors (TKIs) such as gefitinib or erlotinib and sensitivity to other TKIs such as crizotinib. This FISH assay has been validated in both specimen types for detection of MET amplification.
Organ: Lung, Colon & Other GI
Disease State: Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: One of the mismatch repair gene products. Loss of expression can help define 'MSI' type colonic and other carcinomas. In general, loss of MLH1 is accompanied by simultaneous loss of PMS2. Subcellular Localization: Nuclear
Organ: OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State: Mismatch Repair Genes - Correlates with MSI, Hereditary Non-Polyposis Colorectal Carcinoma (HNPCC) / Lynch Syndrome, Microsatellite Instability (MSI), Lynch Syndrome / HNPCC
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: Panel of the mismatch repair (MMR) gene products. Loss of expression can help define 'MSI' type colonic and other carcinomas, i.e., tumors deficient in expression of one or more of the MMR gene products.
Organ: OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342; 88341x3. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Although the expression of MNDA was initially thought to be restricted to the myelomonocytic lineage, several studies have shown the expression of this protein by normal and neoplastic B lymphocytes. MNDA has been shown to be expressed in splenic marginal zone lymphomas, mantle cell lymphomas, nodal marginal zone lymphomas and hairy cell leukemia. MNDA (clone 253A) will be used as part of a larger IHC panel to help distinguish marginal zone B cell lymphoma (MZL) from follicle center-derived B cell lymphoma, particularly CD10-negative FL. Subcellular Localization: Almost entirely Nuclear
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Hairy Cell Leukemia, Mantle Cell Lymphoma, Marginal Zone/MALT Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Epithelial glycoprotein 2, a cell surface protein, expression of which has been demonstrated to help in the distinction of adenocarcinoma (positive) from mesothelioma (negative). As mesotheliomas can express low levels of this protein, this marker is best employed as part of a panel of markers. Subcellular Localization: Membranous
Organ: Lung, Genitourinary, Liver
Disease State: Mesothelioma vs. Adenocarcinoma, Hepatocellular Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: This real time PCR assay detects somatic mutations in codon 515 of the “myeloproliferative leukemia virus oncogene” (“MPL”). These mutations occur in chronic myeloproliferative neoplasms, including primary myelofibrosis (PMF) and essential thrombocythemia (ET). MPL codon 515 (W515) mutations are found in ~3-4% of patients with ET and ~7-8% of patients with PMF; the identification of an MPL mutation fulfills one of the WHO major diagnostic criteria for these diseases. MPL mutations are usually found in chronic myeloproliferative neoplasm cases that are negative for the JAK2 V617F mutation and Calreticulin exon 9 mutations.
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Myeloproliferative Neoplasms (non-CML)
Turnaround Time: Within 5-8 business days of receipt
Schedule: Monday (run and analyzed same day)
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE) block or 10 unstained FFPE slides.
CPT Code(s): 81338; 88381 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: One of the mismatch repair gene products. Loss of expression can help identify tumors in Lynch Syndrome patients, as well as identify 'MSI' type sporadic colonic and other carcinomas. In general, loss of MSH2 is accompanied by simultaneous loss of MSH6. Subcellular Localization: Nuclear
Organ: OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State: Mismatch Repair Genes - Correlates with MSI, Hereditary Non-Polyposis Colorectal Carcinoma (HNPCC) / Lynch Syndrome, Microsatellite Instability (MSI), Lynch Syndrome / HNPCC
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: One of the mismatch repair gene products. Loss of expression can help identify tumors in Lynch Syndrome patients, as well as identify 'MSI' type sporadic colonic and other carcinomas. In general, loss of MSH6 is accompanied by simultaneous loss of MSH2, although selective loss of MSH6 alone can also be seen. Subcellular Localization: Nuclear
Organ: OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State: Mismatch Repair Genes - Correlates with MSI, Hereditary Non-Polyposis Colorectal Carcinoma (HNPCC) / Lynch Syndrome, Microsatellite Instability (MSI), Lynch Syndrome / HNPCC
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: Microsatellite instability (MSI) is the end result of a defective mismatch repair (MMR) system and generally occurs as a result of a germline mutation in one of the MMR genes (hereditary) or as a result of methylation of the MLH1 promoter (sporadic). Microsatellites are repetitive sequences distributed throughout the genome that consist of nucleotide repeats (mono-, di- or higher order nucleotide repeats) that are often copied incorrectly by DNA polymerase. In tumors with mismatch repair defects, these expansions or contractions of the number of nucleotide repeats are not repaired, leading to the phenomenon of MSI. PCR is used to amplify specific microsatellite repeats within the genome and MSI is detected by comparing the length of nucleotide repeats in tumor cells versus normal cells. If the length of the repeat sequences from tumor versus normal differs in 2 or more of the 5 regions tested, microsatellite instability is present, and the specimen is characterized as MSI-high (MSI-H). Specimens showing differing lengths in 1 of the regions tested is characterized as MSI-low (MSI-L). If no differences are seen between the normal and tumor, the sample is considered microsatellite stable (MSS). Cases of hereditary non-polyposis colorectal carcinoma (HNPCC) or Lynch Syndrome and approximately 15% of sporadic colorectal carcinomas (CRC) exhibit defective MMR. In sporadic CRC, MSI is the result of acquired hypermethylation silencing of MLH1. In individuals/families in which HNPCC/Lynch syndrome is suspected, the presence of MSI in a tumor suggests a germline mutation in one of the MMR genes and further mutational testing should be considered. Colorectal carcinomas with defective DNA mismatch repair (MSI-high), have a better prognosis compared to those with intact mismatch repair (microsatellite stable or MSI-low).
Organ: OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State: Mismatch Repair Genes - Correlates with MSI, Hereditary Non-Polyposis Colorectal Carcinoma (HNPCC) / Lynch Syndrome, Microsatellite Instability (MSI), Lynch Syndrome / HNPCC
Turnaround Time: Within 5-8 business days of receipt
Schedule: Wednesday
Specimen Requirements: Both Tumor and Normal Required. 1) Formalin-fixed, paraffin-embedded (FFPE) tissue containing greater than 10% tumor - AND - 2) Formalin-fixed, paraffin-embedded (FFPE) tissue containing normal tissue OR normal peripheral blood (Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top); transport with frozen ice pack)
CPT Code(s): 81301; 88381 may apply; G0452 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: MUM1 gene product, also known as interferon regulatory factor 4. In hematolymphoid neoplasms, MUM1 is positive in multiple myelomas, lymphoplasmacytic lymphomas, Reed-Sternberg cells of Hodgkin lymphoma and in approximately 50% (up to 75% in some studies) of diffuse large B-cell lymphomas (DLBCL). It is expressed at low levels (i.e., in less than 30% of the cells) in marginal zone lymphomas, follicular lymphomas, and B cell CLL/SLL. It is negative on Burkitt’s lymphoma. Subcellular Localization: Nuclear and cytoplasmic
Organ:
Disease State: Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This sensitive breakapart FISH assay detects any rearrangement involving the MYC gene. Translocations involving the MYC gene on chromosome 8 are characteristic chromosomal aberrations of Burkitt's-type lymphomas/leukemias (BLs). On the molecular level, the MYC gene on 8q24 is juxtaposed to the heavy chain locus on 14q32 in most cases or less commonly to light chain loci on 2q11 and 22q11, resulting in constitutive overexpression of the transcription factor, MYC. The detection of translocations involving MYC is a major aim in the diagnosis of patients with high-grade B cell lymphomas because treatment strategies differ between BL and other high-grade B cell neoplasms. Probe type: Dual color breakapart
Organ: Brain/CNS, Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Burkitt's Lymphoma, Diffuse Large B Cell Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The MYD88 L265P mutation is detected in ~90% of lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM) cases, ~30% of activated/non-germinal center type diffuse large B cell lymphomas, ~40% of central nervous system lymphomas, and ~50% of IgM monoclonal gammopathies of undetermined significance (IgM-MGUS). Of note, the presence of an MYD88 L265P mutation has been associated with a higher risk progression in patients with IgM-MGUS. However, the MYD88 L265P mutation is not exclusively identified in these neoplasms and has been reported in other diagnostic entitites.
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Diffuse Large B Cell Lymphoma, Lymphoplasmacytic Lymphoma
Turnaround Time: Within 4-8 business days of receipt
Schedule: Thursday
Specimen Requirements: Formalin-fixed, paraffin-embedded (FFPE) tissue block, 10 FFPE tissue slides, or peripheral blood or bone marrow in EDTA or heparin.
CPT Code(s): 81305. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A protein that is a sensitive and specific marker of carcinomas primary to the breast. Can also be expressed in a subset of salivary gland tumors as well as ovarian carcinomas. Subcellular Localization: Cytoplasmic
Organ: Breast
Disease State: Carcinomas of Unknown Primary, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: MCPV is suspected to be an etiological agent in the majority of cases of Merkel cell carcinoma, and has been reported to be identified by immunohistochemistry in up to 80% of these tumors. MCPV is not detected in non-Merkel cell neuroendocrine tumors.
Organ: Skin & Mucosa
Disease State: Carcinomas of Unknown Primary, Metastatic Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Mesothelin, a cell surface protein expressed by mesothelial cells and mesothelioma, but also by ovarian carcinoma and pancreatic adenocarcinoma. Displays significantly less specificity for mesotheliomas than other markers such as WT-1, calretinin, and podoplanin. Subcellular Localization: Membranous
Organ: Lung, Pancreas
Disease State: Mesothelioma vs. Adenocarcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A mitochondrial antigen. The presence of increased numbers of mitochondria, and hence fine granular positivity with this antibody, can assist in the analysis of eosinophilic tumors (e.g., oncocytomas) of the kidney. Subcellular Localization: Cytoplasmic (granular)
Organ: Genitourinary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies smooth, skeletal, and cardiac isoforms of actin. HHF35 can be employed as a marker of leiomyosarcomas, rhabdomyosarcomas, and tumors showing myoepithelial differentiation. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube is added whenever >20% myeloid blasts are identified by flow cytometry (often when >10% blasts are identified), in order to provide additional characterization of the blasts. This tube can also be helpful in distinguishing benign regenerating myeloid blasts from leukemic myeloid blasts in the setting of post therapy bone marrows. This tube includes antibodies to CD45, CD9, CD133, CD34, CD90, HLA-DR, CD117, CD19, and CD38. Because of recent reports suggesting the prognostic significance of CD25 in AML, we are considering swapping the CD25 for the CD90.
Organ: Blood/Bone Marrow
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x9. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube is designed to help identify erythroid and megakaryocytic differentiation in the setting of AML, and also to help distinguish AML from blastic plasmacytoid dendritic cell neoplasms. The tube includes antibodies to CD45, CD235a (glycophorin A), CD41, CD34, CD117, CD61, and CD11c.
Organ: Blood/Bone Marrow
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x7. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Several recurrent and prognostic chromosome alterations have been identified in myeloma and their identification is useful in the management of these patients. These include translocations involving the FGFR3, MAF, MAFB and CCND1 genes with the IGH gene, loss of 17p13.1(P53), loss of 13q14.3, rearrangement of MYC, and hyperdiploidy. The t(14;16), t(4;14), and t(14;20) translocations involving the MAF, FGFR3, and MAFB genes, respectively, each independently identify poor prognostic groups. Deletion of 13q14.3, rearrangement of MYC, or 17p13.1(P53) are two additional poor prognostic indicators in myeloma. Hyperdiploidy is associated with a favorable prognosis and the t(11;14) portends an intermediate prognosis.
Organ: Blood/Bone Marrow, Body Fluids
Disease State: Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374x6, 88367; 88373x5. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A peroxidase enzyme expressed at high levels in cells showing granulocytic differentiation. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Cytocentrifuge preparations of cell suspensions
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A nuclear transcription factor that plays a key role in the regulation of skeletal muscle differentiation, and can be employed as a highly sensitive and specific marker of rhabdomyosarcoma. Subcellular Localization: Nuclear
Organ:
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A nuclear transcription factor that plays a key role in the regulation of skeletal muscle differentiation, and can be employed as a highly sensitive and specific marker of rhabdomyosarcoma. Subcellular Localization: Nuclear
Organ:
Disease State: Small, Blue, Round Cell Tumors, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Antibodies to myoglobin can be employed to identify myoglobin-containing casts within renal tubules, which can be seen following rhabdomyolysis and in cases of myoglobin cast nephropathy. Myoglobin is NOT recommended as a marker of rhabdomyosarcoma, as much more sensitive markers such as myogenin, myoD1, and desmin are best employed in this setting. Clinical Indication(s): This anti-myoglobin antibody will be used to identify the presence of myoglobin-containing tubular casts in the lumina of renal tubules. Subcellular Localization: Cytoplasmic
Organ: Kidney
Disease State: Renal disease
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: NKX2.2 is a nuclear transcription factor to the NK2 homeobox 2 gene. This transcription factor is involved in neural morphogenesis as well as the development of neuroendocrine cells, such as those of pancreatic islet cells. The expression of NKX2.2 by IHC is a useful biomarker for distinguishing primitive neuroectodermal tumor/ Ewing sarcoma (PNET/ES) from other small blue round cell tumors, when used as a component of a panel of other tests. Subcellular localization: Nuclear
Organ: Soft Tissue
Disease State: Small, Blue, Round Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: A putative tumor suppressor protein that is expressed almost exclusively in the prostate and prostatic adenocarcinoma. It can supplement other markers such as PSA. Subcellular Localization: Nuclear
Organ: Prostate
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: A nuclear protein (NUT) expressed normally in germ cells of the testis and ovary. NUT midline carcinoma (NMC) is defined by the presence of chromosomal rearrangement involving the NUT gene on chromosome 15q14 and immunohistochemically detectable expression of the NUT protein. Subcellular Localization: Nuclear (speckled)
Organ:
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: An aspartic protease expressed at high levels by type II pneumocytes of the lung. NapsinA is a highly sensitive and specific marker of pulmonary adenocarcinoma, although it can also be expressed in a subset of renal cell carcinomas and ovarian carcinomas (i.e., clear cell carcinomas). Subcellular Localization: Granular cytoplasmic
Organ: Lung, OB/GYN
Disease State: Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Expression of Nestin, a common marker of neural progenitor cells, is associated with the triple-negative/basal-like phenotype and poor prognosis. Nestin, in a survey of 46 biomarkers, ranked second highest, as well as having 54% sensitivity and 96% specificity for basal-like breast carcinomas (Won, et al, Modern Pathology 2013;26:1438-1450). A 2-marker panel for identification of basal-like breast carcinomas comprised of INPP4B negativity and/or Nestin positivity was observed to have 83% sensitivity and 96% specificity according to published literature (Parry, et al J Clin Pathol 2008;61:1045-1050). Basal-like and/or triple negative breast cancers account for approximately 15% of all breast carcinomas. They are predominately high grade and are associated with early onset, as well as a poor prognosis. The triple negative immunophenotype is known to be an imperfect correlate of the basal-like genotype as determined by molecular studies. Studies have suggested that Nestin might serve as a useful marker of basal-like breast cancers. Using the 10c2 mouse monoclonal antibody to Nestin, we demonstrated 70% sensitivity and 100% specificity, which is higher than the reported literature. Nestin will be run in a panel with other antibodies, including INPP4B, to identify basal-like breast cancers. Subcellular Localization: cytoplasmic
Organ: Breast
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A neuronal nuclear antigen defined by monoclonal antibody A60. The antigen is expressed by most neuronal cell types throughout the nervous system, including cerebellum, cerebral cortex, hippocampus, thalamus, spinal cord and neurons in the peripheral nervous system, including dorsal root ganglia, sympathetic chain ganglia and enteric ganglia. Subcellular Localization: Nuclear
Organ: Brain/CNS
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The intermediate filament protein comprising neurofilaments, which are expressed exclusively within neurons and tumors showing neuronal differentiation. Subcellular Localization: Cytoplasmic
Organ: Brain/CNS
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Proper WHO classification of aggressive B cell lymphomas is greatly aided by the identification of specific chromosomal alterations involving the MYC, BCL2, BCL6 and IGH genes. The main differential for this class of tumors typically includes Burkitt’s lymphoma, DLBCL, and tumors with morphologic and genetic features intermediate between these two entities. Identification of a “double-hit” (i.e. a MYC rearrangement with either a BCL6 or BCL2 rearrangement) argues against the diagnosis of Burkitt’s and can provide support for the intermediate category, although such double hits can also occur in DLBCL. The findings of this panel of FISH studies should be correlated with the clinical features and the histologic and immunophenotypic findings.
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Burkitt's Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374x4. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Octamer transcription factor 2. Oct-2 and Bob-1 are transcription factors expressed by all normal B cells throughout maturation (from immature forms to plasma cells). These factors are co-expressed in almost all non-Hodgkin lymphomas, plasma cell neoplasms, and nodular lymphocyte predominance lymphomas, but one or both is aberrantly lost in nearly all cases of classical Hodgkin lymphoma. Subcellular Localization: Nuclear
Organ:
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Classical Hodgkin Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Nuclear transcription factor expressed at high levels in embryonal carcinoma and seminoma, and used as part of a panel in the subclassification of germ cell tumors. Subcellular Localization: Nuclear
Organ: OB/GYN, Genitourinary, Testis, Ovary
Disease State: Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Deletion involving the cyclin-dependent kinase inhibitor 2A/p16 gene at the 9p21 locus on chromosome 9 is frequently observed in mesothelioma. Homozygous deletion of this gene has been reported in 22-74% of mesotheliomas. This characteristic of mesotheliomas can be employed in the often-difficult differential diagnoses of spindle cell mesothelial proliferations where immunohistochemical markers cannot distinguish between benign and malignant mesothelial proliferations. While a negative result for homozygous p16 deletion cannot rule out the possibility of a mesothelioma, a positive result is highly specific for mesothelioma in the appropriate clinical setting.
Organ: Lung
Disease State: Mesothelioma vs. Adenocarcinoma, Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A nuclear protein expressed throughout B cell maturation prior to the plasma cell stage, at which point it is no longer expressed. PAX-5 is strongly expressed in the great majority of mature and immature B cell neoplasms, and in nodular lymphocyte predominance Hodgkin lymphoma. PAX-5 is expressed at decreased intensity in classical Hodgkin's lymphoma, and is not expressed in the great majority of plasma cell neoplasms. Subcellular Localization: Nuclear
Organ:
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Classical Hodgkin Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma, Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: PAX-6 is a member of the paired box protein family, and is a sensitive marker of pancreatic endocrine neoplasms. However, there is a lack of specificity as PAX-6 is also expressed by other neuroendocrine neoplasms and even some non-neuroendocrine tumors (e.g., endometrial and ovarian carcinomas). Subcellular Localization: Nuclear
Organ: Pancreas, Ovary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A nuclear transcription factor that is a marker of renal cell carcinoma as well as carcinomas of the GYN tract (ovary, endometrium). Also expressed in thyroid carcinomas. Subcellular Localization: Nuclear
Organ: OB/GYN, Genitourinary, Thyroid
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Programmed cell death protein 1 (PD-1; CD279), a cell surface protein in the immunoglobulin superfamily that is a marker of follicular helper T (TFH) cells, and can be expressed by other subsets of T cells.  TFH cells are normally found in the germinal centers of benign lymphoid tissues, and are the putative cell of origin for some T cell non-Hodgkin lymphomas, including angioimmunoblastic T cell lymphomas.  The interaction of PD-1 with either of its two ligands - PD-L1 and PD-L2 - typically diminishes T cell immune responses by stimulating their programmed cell death, such that PD-L1 and PD-L2 expression by tumor cells is thought to be a major mechanism by which cancer evades the immune system.  Accordingly, anti-PD-1 therapy represents a promising new therapy designed to enhance ability of the immune system to target and kill cancer cells. Subcellular Localization: Membranous or cytoplasmic
Organ:
Disease State: Angioimmunoblastic T Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: PD-L1 IHC 22C3 pharmDx is intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissues to identify patients for eligibility for treatment with KEYTRUDA® (pembrolizumab). Tumor Indications include: non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (HNSCC). PD-L1 protein expression in NSCLC is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. A positive score is TPS ≥ 1%. PD-L1 protein expression in gastric or GEJ adenocarcinoma, ESCC, cervical cancer, urothelial carcinoma and HNSCC is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. Postivie scores are CPS≥1 for GEJ, cervical cancer, and HNSCC, and CPS≥10 for ESCC and urothelial carcinoma.
Organ: Lung, Genitourinary, Colon & Other GI
Disease State: Non Small Cell Lung Carcinoma (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, Esophageal Squamous Cell Carcinoma (ESCC), Cervical Cancer, Urothelial Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 2 unstained slides for each test requested plus 3-4 additional unstained slides cut at 4µm** **After sectioning, tissues should be mounted on Dako FLEX IHC microscope slides (Code K8020) or Superfrost Plus slides and then placed in a 58 ± 2 °C oven for 1 hour. To preserve antigenicity, tissue sections, once mounted on slides, should be held in the dark at 2-8 °C (preferred), or at room temperature up to 25 °C. Slide storage and handling conditions should not exceed 25 °C at any point post-mounting to ensure tissue integrity and antigenicity. Cut Section Storage Recommendations NSCLC: sections must be stained within 6 months when stored at 2-8 ºC (preferred), or at 25 ºC. Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma: sections must be stained within 5 months when stored at 2-8 ºC (preferred), or at 25 ºC. ESCC: sections must be stained within 4.5 months when stored at 2-8 °C (preferred), or within 1 month when stored at 25 °C. Cervical Cancer: sections must be stained within 5 months when stored at 2-8 ºC (preferred), or within 1 month when stored at 25 ºC. Urothelial Carcinoma: sections must be stained within 1 month when stored at 2-8 °C (preferred), or at 25 °C. HNSCC: sections must be stained within 6 months when stored at 2-8 °C (preferred), or within 4 months when stored at 25 °C.
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. NSCLC: PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). As a Companion Diagnostic for ≥ 1% tumor cell expression. Non-squamous NSCLC: PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). SCCHN: PD-L1 expression (≥ 1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab). UC: PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO® (nivolumab).
Organ: Lung
Disease State: Non Small Cell Lung Carcinoma (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Urothelial Carcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 2 unstained slides for each test requested plus 3-4 additional unstained slides cut at 4µm** **After sectioning, tissues should be mounted on Dako FLEX IHC microscope slides (Code K8020) or Superfrost Plus slides and then placed in a 58 ± 2 °C oven for 1 hour. Recommended handling and processing conditions are: <30 minutes ischemia time prior to immersion in fixative, and 24- 48 hours fixation time in neutral buffered formalin. Alternative fixatives have not been validated and may give erroneous results. To preserve antigenicity, tissue sections, once mounted on slides, should be stored in the dark at 2-8 °C and stained within 4 months of sectioning. The use of PD-L1 IHC 28-8 pharmDx on decalcified tissues has not been validated and is not recommended.
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: PD-L1 (Programmed Death-Ligand 1), also known as CD274, is a 40 kDa type 1 transmembrane protein that has been speculated to play a major role in suppressing the immune system. Binding of PD-L1 to its ligand PD-1, which is expressed by various immune cell types including T cells, transmits an inhibitory signal that attenuates T cell function, expansion, and survival. Many tumors types can express PD-L1, including breast, ovarian, gastric, pancreatic, lung and renal cell carcinomas, and classical Hodgkin lymphoma. PD-L1 expression by tumor cells is thought to inhibit the local immune response to the tumor, at least in part by binding to T cell PD-1 and protecting the tumor from T-cell mediated immunity. Blockade of the PD-1/PD-L1 axis by humanized monoclonal antibodies against PD-1 and PD-L1 has emerged as a promising new cancer therapy. The anti-PD-1 antibodies nivolumab and pembrolizumab have received FDA approval for treating metastatic squamous NSCLC and metastatic melanoma, respectively. Expression of PD-L1 by tumors may predict response to these drugs. The main clinical indication for PD-L1 IHC is expected to be assessment of PD-L1 expression on tumor cells prior to the initiation of therapy targeting the PD-1 / PD-L1 axis. However, unforeseen clinical indications cannot be excluded. Subcellular Localization: membranous and cytoplasmic
Organ: Lung, Skin & Mucosa
Disease State: Melanoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: VENTANA PD-L1 (SP142) assay is an FDA approved IVD assay using rabbit monoclonal anti-PD-L1 clone SP142 intended for assessment of the PD-L1 protein in urothelial carcinoma tissue. PD-L1 status is determined by the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (%IC) of any intensity. PD-L1 expression in ≥ 5% IC determined by VENTANA PD-L1 (SP142) assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of Atezolizumab. Subcellular Localization: Membranous (on immune cells)
Organ: Genitourinary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block - OR - • 2 unstained slides for each test requested plus 3-4 additional unstained slides cut at 4µm Decalcified specimens are unacceptable Slides should be stained promptly, as antigenicity of cut tissue sections may diminish over time and may be compromised 3 months after cutting from the paraffin block for urothelial carcinoma specimens, 2 months for NSCLC, TNBC, and tonsil specimens.
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: The FIP1L1-PDRGFRα fusion is a genetic abnormality found in idiopathic hypereosinophilic syndrome (HES), or primary eosinophilia. HES is a chronic and typically slowly progressive disease that eventually results in organ damage. Several molecular mechanisms have been identified, including FIP1L1-PDGFRα and rearrangements of PDGFRβ and FGFR1. Presence of the FIP1L1-PDGFRα fusion is associated with positive response to imatinib mesylate (Gleevec) therapy. While molecularly defined eosinophilias are relatively rare, approximately one-quarter of HES patients have been shown to harbor this mutation. In these patients, imatinib therapy improves 5-year survival rates to from ~75% to 90-95% and reduces rates of progression from 50% down to less than 1%.
Organ: Blood/Bone Marrow
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Rearrangement of PDGFRB is one of several molecularly defined mechanisms identified in eosinophilia-associated myeloid and lymphoid neoplasms. These neoplasms often present with features similar to chronic myelomonocytic leukemia (CMML), including leukocytosis with anemia and thrombocytopenia, and hypercellular bone marrow with increased reticulin fibrosis. The most common translocation partner is ETV6 [t(5;12)(q33;p13), although more than 20 others have been described. The translocation encodes a constitutively activated tyrosine kinase that responds to imatinib therapy.
Organ: Blood/Bone Marrow
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: An enzyme highly expressed in seminoma. Traditionally employed as a marker of seminoma, there are now more sensitive and specific markers (e.g., Oct-3/4 and SALL4) that can be employed in the identification and subclassification of germ cell tumors. Subcellular Localization: Cytoplasmic
Organ: Genitourinary, Testis, Ovary
Disease State: Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: One of the mismatch repair gene products. Loss of expression can help identify tumors in Lynch Syndrome patients, as well as identify 'MSI' type sporadic colonic and other carcinomas. In general, loss of PMS2 is accompanied by simultaneous loss of MLH1. Cellular Localization: Nuclear
Organ: OB/GYN, Skin & Mucosa, Colon & Other GI
Disease State: Mismatch Repair Genes - Correlates with MSI, Hereditary Non-Polyposis Colorectal Carcinoma (HNPCC) / Lynch Syndrome, Microsatellite Instability (MSI), Lynch Syndrome / HNPCC
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: PNL2 is a marker of melanocytes and melanocytic tumors. Identification of PNL2 expression by IHC is useful for the identification of melanomas (both primary and metastatic) and to distinguish them from other tumor types. Subcellular localization: Cytoplasmic
Organ: Skin & Mucosa, Lymph Node / Spleen
Disease State: Large Cell Undifferentiated Malignant Neoplams, Melanoma, Clear Cell Sarcoma, PEComas
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A highly sensitive and specific marker of metastatic prostatic adenocarcinoma. Recent studies suggest that a novel prostatic marker, NKX3.1, may be even more sensitive and specific. Subcellular Localization: Cytoplasmic
Organ: Genitourinary, Prostate
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Phosphatase and tensin homolog, a tumor suppressor that is mutated, and expression of which is lost, in a number of human tumors. Loss of expression of PTEN may be a prognostic and predictive biomarker in some of these tumors. Subcellular Localization: Cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The hormone produced by parathyroid glands and parathyroid adenoma/carcinoma. Subcellular Localization: Cytoplasmic
Organ: Hormones
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The Pan-TRK immunohistochemical assay detects expression of tropomyosin receptor kinase A, B, and C proteins arising from the NTRK 1, 2, and 3 genes, respectively. NTRK gene rearrangements occur in many different tumor types, often at low frequency, including lung non-small cell carcinomas (~1%), colorectal and other gastrointestinal related adenocarcinomas, breast carcinomas, melanoma, renal cell carcinomas, and adult brain tumors. Molecular testing (i.e, NGS or FISH) for an NTRK gene fusion is recommended for any equivocal result by this assay to confirm the presence of an NTRK gene fusion. Patients having a tumor harboring an NTRK gene fusion may be responsive to NTRK inhibitor therapy (Ref: Cocco E, et al. Nat Rev Clin Oncol. 2018 December ; 15(12): 731–747; Amatu A, et al. ESMO Open 2016;1:e000023. doi:10.1136/esmoopen-2015-000023; Vaishnavi A, Le AT, Doebele RC. Cancer Discov. 2015;5(1):25-34).
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A subset of islet cell tumors of the pancreas (PPomas). Subcellular Localization: Cytoplasmic
Organ: Pancreas, Hormones
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341/antibody. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: Red blood cells are evaluated for deficiency of Gpi8 linkages using antibodies to CD235a/glycophorin A and CD59. The leukocytes are evaluated for loss of Gpi8 linkages using antibodies to CD45, CD33, HLA-DR (the latter two to help separate monocytes from granulocytes in gating), FLAER, CD24, CD14, and CD16. An antibody to CD10 is also present, to aid in the identification of mature neutrophils among the myeloid cells.
Organ: Blood/Bone Marrow
Disease State: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: Ideally performed on peripheral blood; can be performed on bone marrow aspirate (less desirable than blood): • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top)
CPT Code(s): 88184 x 1, 88185 x 9, 88188 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Identification of parvovirus in human tissues. Subcellular Localization: Nuclear
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Podoplanin, a marker of lymphatic endothelium, as well as neoplasms such as Kaposi’s sarcoma. In the context of epithelial tumors, podoplanin has also been demonstrated to be a highly sensitive marker of mesothelium and mesothelioma, complementing other markers such as calretinin and the Wilms tumor gene product. Subcellular Localization: Membranous and cytoplasmic
Organ: Lung
Disease State: Mesothelioma vs. Adenocarcinoma, Follicular Dendritic Cell Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies cells harboring JC/polyoma/SV-40/BK virus. Subcellular Localization: Nuclear
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A prognostic and predictive marker of breast and other cancers. Subcellular Localization: Nuclear
Organ: Breast, Pancreas, Hormones
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360 or 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: The IHC Prostate Multiplex assay is intended for the qualitative identification of Keratin 5/14, p63 protein and P504S by two-color immunohistochemistry (IHC). Keratin 5 and Keratin 14 are expressed in the basal cells of normal prostate glands and prostatic intraepithelial neoplasia (PIN), a precursor lesion to prostatic adenocarcinoma; however, expression of Keratin 5 or Keratin 14 is not seen in invasive prostatic adenocarcinoma. p63 is detected in nuclei of the basal epithelium in normal prostate glands and prostatic intraepithelial neoplasia (PIN), and is not seen in the vast majority of adenocarcinomas of the prostate. Alpha-Methyl Acyl-CoA-Racemase (AMACR or Racemase) is the gene product of P504S, a peroxisomal and mitochondrial enzyme that plays a role in bile acid synthesis and oxidation of branched chain fatty acids. By immunohistochemistry, AMACR/P504S is very frequently expressed in prostatic adenocarcinoma. Prostate glands involved in prostatic intraepithelial neoplasia (PIN) have also been found to express AMACR/P504S, whereas in most cases, AMACR/P504S is negative in benign glands. Together, the presence of Racemase expression in atypical glands, and the absence of basal cells (negative staining for p63, Keratins 5 and 14) can aid in the diagnosis of prostatic adenocarcinoma.
Organ: Genitourinary, Prostate
Disease State: Adenocarcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88344. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This breakapart FISH assay detects rearrangements involving the RARA gene. Translocations involving the RARA gene are present in acute promyelocytic leukemia (APL), which is a distinct form of acute leukemia (AML-M3) that accounts for 10% of cases and is characterized by promyelocytes, thrombocytopenia, disseminated intravascular coagulation (DIC), and sensitivity to all-trans-retinoic acid (ATRA). The most common translocation partner for RARA in APL is the PML gene resulting in the t(15;17)(q22;q12). The RARA breakapart FISH probe also detects the three variant translocations involving the RARA gene in APL which include: 1) t(11;17)(q23;q21) involving the promyelocytic leukemia zinc finger gene (PLZF) on 11q23, 2) t(5;17)(q23;q21) involving the nucleophosmin (NPM) on 5q23, and 3) t(11;17)(q23;q21) involving the nuclear matrix associated gene (NUMA) on 11q13. Acute promyelocytic leukemias involving the variant t(11;17)(q23;q21) have been reported to be resistant to ATRA whereas those with variant t(5;17)(q23;q21) appear to respond to ATRA. Probe type: Dual color breakapart
Organ: Blood/Bone Marrow, Body Fluids
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: Please refer to "Extended RAS"
Organ:
Disease State:
Turnaround Time:
Schedule:
Specimen Requirements:
CPT Code(s):

Methodology: FISH
Clinical Significance: The purpose and clinical utility of this FISH assay is to evaluate a patient tumor sample for the presence of a RET gene rearrangement. Tumors that contain a RET gene rearrangement may be responsive to treatment with tyrosine kinase inhibitor drug therapy such as vandetanib or cabozantenib. Therefore, patients that are positive for the rearrangement may benefit from this treatment. Tumor types that contain RET gene translocations that have been described include those resulting from non-small cell lung cancer as well as thyroid cancer.
Organ: Lung
Disease State: Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: ROS-1 is a an orphan receptor tyrosine kinase that is phylogenetically related to the ALK tyrosine kinase gene. ROS-1 rearrangements have been found to occur in approximately 2% of lung adenocarcinomas and several gene fusion partners have been identified including CD74, LRIG3, SDC4, TPM3, and FIG. Tumors that harbor a ROS-1 gene rearrangement have been found to be responsive to treatment with the ALK inhibitor drug crizotinib (Xalkori). Recent studies have demonstrated that FISH can be used to identify ROS-1 rearrangements in lung adenocarcinoma. A positive result with this test would therefore indicate that the patient may respond to treatment with crizotinib*. *NOTE: Determining insurance eligibility is the responsibility of the patient and their physician.
Organ: Lung
Disease State: Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: ROS1 (also know as ROS, MCF3 and c-ros-1) is a proto-oncogene highly expressed in a variety of tumor cells.  Immunohistocheminal localization of ROS1 can be used to distinguish cancers containing the ROS1 translocation and may serve as a possible surrogate for ROS1 FISH using a breakapart probe. The c-ROS oncogene 1 receptor tyrosine kinase (ROS1) gene is located on human chromosome 6. Rearrangement of ROS1 results in the production of constitutively active fusion proteins that have been reported in non-small cell lung cancers (NSCLC).  ROS1 fusion protein plays a central role in cancer growth and development by increasing the translation of genes associated with cell proliferation, migration and metastasis. Published data suggest that ROS1-rearranged cancers respond to ALK inhibitors.  The performance characteristics of this antibody, as established by PhenoPath, justify its use as an alternative to, or in conjunction with, ROS1 FISH for the identification of lung adenocarcinomas harboring ROS1 gene translocations. Subcellular Localization: Cytoplasmic
Organ: Lung
Disease State: Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This two-tube assay includes one tube targeted primarily at mature B cells, and a second tube targeted primarily at mature T and NK cells. This panel is ideal for ruling out lymphoma in any type of fresh material. Both tubes contain nine antibodies (“9 colors”), with a tenth color allowing use of the DNA binding dye DAPI to facilitate exclusion of DAPI-positive dead and dying cells from the analysis. Antigens evaluated in the B cell tube include CD45, kappa, lambda, CD19, C5, CD20, CD10, CD56, and CD38. Antigens evaluated in the T cell tube include CD45, CD2, CD7, CD3, CD34, CD56, CD5, CD4, and CD8. Potential add-on tubes include: • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)/ mantle cell lymphoma (MCL) add-on tube • Follicular lymphoma (FL)/Burkitt lymphoma (BL) add-on tubes • Hairy cell leukemia/marginal zone lymphoma add-on tube • CD5-negative B cell therapy add-on tube • CD5-positive B cell therapy add-on tube • Rule out plasma cell dyscrasia tube • B cell versus plasma cell add-on tube • T cell receptor add-on tube • T cell therapy add-on tube • Large T cell therapy add-on tubes • B-ALL add-on tube • T-ALL add-on tube
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen, Thymus (Mediastinal Mass), Other tissue sites
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, B Cell Non-Hodgkin Lymphoma (not otherwise classified), B Cell NHL with Plasmacytoid Differentiation, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Hairy Cell Leukemia, HIV-Associated Lymphoma, Marginal Zone/MALT Lymphoma, NK/T Cell Lymphoma, Nasal Type, Post-Transplant Lymphoproliferative Disorders, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Plasma Cell Myeloma/Neoplasm, Lymphoplasmacytic Lymphoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88184 x 1, 88185 x 14, 88188 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This two-tube panel is designed to look for aberrant expression of CD25 and/or CD2 among the brightly CD117+ mast cells in the marrow. It is a two-tube panel because isotype controls are used for the CD2 and CD25 antibodies. The antibodies in these tubes include CD45, CD2, CD33, CD34, CD25, HLA-DR, CD117, CD4, and CD38.
Organ: Blood/Bone Marrow
Disease State: Mastocytosis
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88184 x 1, 88185 x 8, 88188 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This panel identifies neoplastic plasma cell populations on the basis of cytoplasmic light chain restriction, but can also be used to identify cytoplasmic light chain restriction in the setting of an abnormal B cell population with aberrant loss of surface light chains. This panel contains antibodies to CD45, CD19, CD56, CD20, CD5, and CD38 (the latter all added to surface antibodies; after permeabilization of the cells, antibodies to cytoplasmic kappa and lambda are added). Potential add-on tubes include: • B cell versus plasma cell add-on tube
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: B Cell NHL with Plasmacytoid Differentiation, Marginal Zone/MALT Lymphoma, Plasma Cell Myeloma/Neoplasm, Lymphoplasmacytic Lymphoma
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88184 x 1, 88185 x # of antibodies, 88188 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A nuclear and cytoplasmic marker of a wide subset of tumors, but traditionally employed as a sensitive marker of melanoma, glial and schwann cell tumors. Subcellular Localization: Cytoplasmic
Organ: Skin & Mucosa
Disease State: Large Cell Undifferentiated Malignant Neoplams, Spindle Cell Tumors / Sarcoma Subtyping, Langerhans Cell Histiocytosis, Melanoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: SALL4 is a very sensitive marker for germ cell tumors, including seminoma, embryonal carcinoma, yolk sac tumor, and choriocarcinoma. SALL4 aLso shows high specificity for germ cell tumors, although positive in a subset of gastric carcinomas. Subcellular Localization: Nuclear
Organ: OB/GYN, Genitourinary, Testis, Ovary
Disease State: Large Cell Undifferentiated Malignant Neoplams, Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Nuclear localization of SF-1 can be used to distinguish sex cord-stromal tumors (SCST) from non-sex cord-stromal tumors (e.g., borderline tumors, serous carcinomas, etc.) and is therefore useful in the differential diagnosis of these neoplasms. Antibodies to SF-1 should be run in a panel with other sex cord-stromal tumor markers, such as inhibin and calretinin. Subcellular localization: Nuclear
Organ: OB/GYN, Genitourinary, Pituitary, Testis, Ovary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: A component of smooth muscle myosin, a protein expressed in cells and tumors showing smooth muscle or myoepithelial differentiation. May also be expressed in myofibroblasts. Most commonly employed to distinguish invasive v. in situ breast carcinoma, usually in conjunction with at least one other myoepithelial marker, e.g., p63. Subcellular Localization: Cytoplasmic
Organ: Breast
Disease State: Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: SOX10 is a highly specific and sensitive nuclear transcription factor found in nerve sheath tumors (e.g., schwannomas) and melanomas. It is also expressed in the majority of desmoplastic and spindle cell melanomas. While S100 is also positive on these tumors, SOX10 is far more specific than S100. SOX10 has also been found to be expressed in salivary gland as well as soft tissue tumors showing myoepithelial differentiation. SOX 10 should be employed in the context of a panel of antibodies for the identification of melanoma and nerve sheath tumors. Subcellular Localization: Nuclear
Organ: Skin & Mucosa, Soft Tissue
Disease State: Melanoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: SOX11 is a transcription factor expressed in almost all cases of mantle cell lymphoma (MCL), including the rare entity cyclin D1-negative MCL. It is not expressed in potential MCL mimics such as atypical chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), follicular lymphoma, and marginal zone lymphoma (Soldini D, et al. Am J Surg Path 38:86-93, 2014). Subcellular Localization: Nuclear
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Mantle Cell Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This sensitive breakapart assay detects any translocation involving the SYT gene. The most common of these translocations is the t(X;18) that juxtaposes the SYT gene with the SS18 gene and is the hallmark translocation of synovial sarcoma. Rearrangement of the SYT gene in these tumors can be detected in over 90% of cases. Evaluation for an SYT rearrangement is thus a useful test when synovial sarcoma is a diagnostic consideration. Probe type: Dual color breakapart
Organ: Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: One of the members of the somatostatin receptor family of proteins, SSt2A is a marker of low grade neuroendocrine carcinomas (e.g. carcinoid), pheochromocytoma, and meningioma. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: STAT (Signal Transducer and Activator of Transcription) proteins are transcription factors that are normally located in the cytoplasm in latent form and migrate to the nucleus on cytokine exposure and subsequent phosphorylation. Studies have demonstrated the presence of recurrent fusions between NAB2 and STAT6 in chromosome 12q13 in the majority of solitary fibrous tumors/hemangiopericyomas. Nuclear STAT6 immunoreactivity has been reported as a surrogate marker for the NAB2-STAT6 gene fusion, which is the defining driver mutation of solitary fibrous tumor/hemangiopericytoma. Subcellular Localization: nuclear
Organ: Soft Tissue
Disease State: Spindle Cell Tumors / Sarcoma Subtyping, Solitary Fibrous Tumor, Hemangiopericytoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top)
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: A peptide marker of intestinal neuroendocrine cells and carcinoid tumors. Subcellular Localization: Cytoplasmic
Organ: Pancreas, Hormones
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Immunofluorescence
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: Patient serum, minimum volume of 3 mL of blood
CPT Code(s): 88346 or 88350. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Leiomyomas, leiomyosarcomas, and mesenchymal tumors manifesting myofibroblastic differentiation (where the antibody often displays a 'tram track' appearance). Subcellular Localization: Cytoplasmic (filamentous)
Organ:
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: A highly sensitive and specific marker of neural and neuroendocrine cells and tumors. Shows superior sensitivity to chromogranin A in the context of high grade neuroendocrine carcinomas. Also expressed in PNET/ES and other tumors showing neural differentiation.

Subcellular Localization: Cytoplasmic, finely granular
Organ: Lung, Colon & Other GI, Pancreas, Thyroid
Disease State: Small, Blue, Round Cell Tumors, Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube assesses TCR-alpha-beta and TCR-gamma-delta expression in the T cell population of interest, including looking for aberrant loss of TCR-alpha-beta in abnormal T cell populations. The baseline antibodies in this tube include CD45, TCR-gamma-delta, TCR-alpha-beta, CD3, CD56, CD4, CD5, and CD8.
Organ: Blood/Bone Marrow, Lymph Node / Spleen, Thymus (Mediastinal Mass)
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, NK/T Cell Lymphoma, Nasal Type, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL), Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x8. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube enables characterization of additional antigens, including the potential therapeutic targets CD52 and CD25, in T cell or NK cell populations of interest. The tube includes antibodies to CD45, CD279, CD52, CD3, CD25, CD4, CD5, CD16 and CD8; additional antibodies can be added as necessary to identify the abnormal T or NK cell population.
Organ: Blood/Bone Marrow, Lymph Node / Spleen
Disease State: Angioimmunoblastic T Cell Lymphoma, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x8. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This tube is designed to assess surface CD1a and nuclear TdT in the setting of expanded immature T cell populations, and includes the following antibodies: CD45, TdT, CD1a, CD3, CD34, CD33, CD99, and HLA-DR.
Organ: Blood/Bone Marrow, Lymph Node / Spleen, Thymus (Mediastinal Mass)
Disease State: Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88185x8. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FLOW
Clinical Significance: This panel is designed to detect residual T-ALL after therapy, and includes antibodies to CD45, CD2, CD1a, CD3, CD34, CD56, CD5, CD4, and CD8.
Organ: Blood/Bone Marrow, Lymph Node / Spleen, Thymus (Mediastinal Mass)
Disease State: Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL)
Turnaround Time: Physician will be contacted by 9:00 PM PST the day of receipt for acute/life threatening conditions; next business day for routine flow cases.
Schedule: Monday-Saturday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Tissue: Finely minced tissue in RPMI transport media - OR - • Body fluids: In RPMI transport media
CPT Code(s): 88184 x 1, 88185 x 8, 88188 x 1. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a protein present in both the cytoplasm and nucleus of the following:  immature normal T-cells; T-cell prolymphocytic leukemia (in which TCL-1 overexpression due to chromosomal translocation is the key pathogenetic event); a variety of B-cell lymphoproliferative disorders including CLL/SLL; and blastic plasmacytoid dendritic cell neoplasms.  TCL-1 protein function has been studied predominately in T-cells, in which it has been demonstrated to bind to the AKT protooncogene and to enhance both AKT enzymatic activity and translocation from cytoplasm to nucleus. Subcellular Localization: Nuclear, some cytoplasmic
Organ:
Disease State: Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: This PCR-based assay evaluates T cell clonality as part of the diagnostic work-up of specimens containing atypical T cell populations. It can be used in conjunction with TCR-gamma PCR studies in order to increase the likelihood of identifying such populations in reactive as well as neoplastic T cell proliferations. TCR-β clonal rearrangements can be identified in both mature and immature T cell lymphomas and leukemias and can aid in the diagnosis of such neoplasms in conjunction with other diagnostic modalities such as histology, immunohistochemistry and flow cytometry.
Organ: Skin & Mucosa, Blood/Bone Marrow, Lymph Node / Spleen, Thymus (Mediastinal Mass)
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, NK/T Cell Lymphoma, Nasal Type, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL)
Turnaround Time: Within 3-5 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 81340; 88381 may apply; G0452 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: PCR
Clinical Significance: The TCR-gamma Clonality Assay is a multiplex fluorescent PCR assay based on the pan-European collaborative study (BIOMED-2). This assay uses the Vgamma 1f/10 and Vgamma 9/11 primer sets utilized by BIOMED-2 for the analysis of TCR gamma gene rearrangements. Importantly, this test should be interpreted in the context of clinical, histologic, and immunophenotypic information and should not be used in isolation in the evaluation of possible T cell lymphoproliferative disorders. Clinical indications for the test include: • Any suspect T cell proliferation when morphology and immunophenotyping are not conclusive, particularly in atypical proliferations in the skin • Lymphoproliferations in immunodeficient patients • Evaluation of the clonal relationship between two T lymphoid malignancies in one patient or discrimination between a relapse and a second malignancy • Occasionally, staging of T cell lymphomas • Aid in minimum residual disease detection Type: PCR/Capillary Electrophoresis, Qualitative
Organ: Skin & Mucosa
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Angioimmunoblastic T Cell Lymphoma, NK/T Cell Lymphoma, Nasal Type, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Precursor T-Lymphoblastic Lymphoma/Leukemia (T-ALL)
Turnaround Time: Within 3-5 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 81342; 88381 may apply; G0452 may apply. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The alpha/beta chain of the T cell receptor, present on normal T lymphocytes and most T cell neoplasms, e.g., peripheral T cell lymphoma (PTCL), T-lymphoblastic lymphoma/leukemia, mycosis fungoides. Negative on normal B cells, B cell neoplasms, anaplastic large cell lymphoma (ALCL), and NK/T cell neoplasms. Subcellular Localization: Membranous
Organ:
Disease State: Angioimmunoblastic T Cell Lymphoma, Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Transcription factor E3, a member of the helix-loop-helix family of transcription factor. Overexpression of TFE3 results from the presence of a chromosomal translocation involving Xp11, present in alveolar soft part sarcoma and a subset of “translocation” renal cell carcinomas. Subcellular Localization: Nuclear
Organ: Genitourinary
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Translocations involving the TFE3 gene at Xp11.2 have been described in a subset of tumors including renal cell carcinomas as well as in alveolar soft part sarcoma (see reference 3). TFE3 FISH is therefore indicated where the presence of a TFE3 translocation is being considered during the pathologic evaluation of the tumor.
Organ: Kidney
Disease State: ,
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A cytoplasmic protein expressed in a coarse granular pattern in both cytotoxic T cells and NK cells, and on neoplasms arising from these cell types, including the majority of anaplastic large cell lymphomas. Subcellular Localization: Granular and cytoplasmic staining
Organ: Skin & Mucosa, Blood/Bone Marrow, Lymph Node / Spleen, Soft Tissue
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), NK/T Cell Lymphoma, Nasal Type, T Cell Non-Hodgkin Lymphoma (not otherwise classified), Peripheral T Cell Lymphoma, NOS (of Large Cell Type)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Topoisomerase II-α (TOP2A) fluorescence in situ hybridization (FISH) is used for evaluation of TOP2A gene amplification and/or deletion in some cancers. Topoisomerase II is located near the HER2 (ERBB2) gene on chromosome 17. A significant subset (~30-40%) of breast cancer patients who show HER2 gene overexpression by FISH show gene amplification and/or deletion of TOP2A. Since adriamycin-based therapies limit cell growth by targeting TOP2A, identifying patients showing TOP2A gene amplification may help to identify those patients who may benefit from adriamycin-based therapies. In addition, deletion of TOP2A has also been associated with response to adriamycin-based therapies. Chemotherapies incorporating anthracyclines (daunorubicin, doxorubicin, and epirubicin), which are thought to act through the enzyme TOP2A in cancer cells, are commonly employed in the treatment of breast cancer. Since benefit from anthracycline-based adjuvant chemotherapy may be restricted to a subgroup of patients, a method of identifying these patients has long been sought. In the past, HER2 gene amplification (by FISH) and protein overexpression (by IHC) have been associated with anthracycline sensitivity, and it has been hypothesized that in such patients the HER2 biomarker represents a surrogate marker for amplification of the TOP2A gene present in the same region of chromosome 17. Promising evidence and strong corroboration of this hypothesis has been presented recently. Investigators recently found that TOP2A was co-amplified in 37% of HER2-amplified breast cancers, and only those HER2 amplified patients with concomitant TOP2A gene amplification showed improved overall survival from individually tailored and dose-escalated, anthracycline-based adjuvant chemotherapy. In the former study, published by the Danish Breast Cancer Cooperative Group, investigators found that patients with TOP2A gene amplification had significantly increased recurrence-free and overall survival when treated with anthracycline-based chemotherapy; in this study, however, a nearly identical hazard ratio was found in patients with either TOP2A deletions or TOP2A gene amplification. Thus, TOP2A gene amplification and deletion may predict response to anthracycline-containing breast chemotherapy, suggesting that TOP2A FISH studies may play a promising role as a predictive marker of tumor sensitivity to these drugs. Probe type: Dual color enumeration
Organ: Breast
Disease State: Adenocarcinoma, Breast Cancer
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Send out test
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Variable, depending on where specimen is sent; contact Client Services for additional information
Schedule:
Specimen Requirements: • Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR - • FFPE solid tumor tissue, Preferred: Paraffin block / Acceptable: 1 H&E plus 5-10 unstained slides cut at 5 or more microns
CPT Code(s): Variable, depending on where specimen is sent; contact Client Services for additional information

Methodology: IHC
Clinical Significance: Identifies: A nuclear transcription factor that is expressed in a very high percentage of lung and thyroid carcinomas. In lung carcinomas, it is expressed in both non-neuroendocrine as well as endocrine neoplasms, but only rarely in lung squamous cell carcinomas. It is expressed in all variants of thyroid carcinoma with the exception of anaplastic carcinoma. TTF1 loses its organ specificity in the context of high grade neuroendocrine carcinomas. It can also more uncommonly be expressed in other carcinomas, including those primary to the colorectum and breast. Subcellular Localization: Nuclear
Organ: Lung, Thyroid
Disease State: Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Adenocarcinoma, Non Small Cell Lung Carcinoma (NSCLC)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Terminal deoxynucleotidyltransferase, a specialized DNA polymerase expressed in immature, pre-B, pre-T lymphoid cells, and also the majority of precursor B- and T-lymphoblastic leukemias/lymphomas. TdT is aberrantly expressed in a small subset of acute myeloid leukemias. Subcellular Localization: Nuclear
Organ:
Disease State: Small, Blue, Round Cell Tumors, Blastic Plasmacytoid Dendritic Cell Neoplasm
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Thrombomodulin (CD141), an integral membrane protein expressed on the surface of endothelial cells, and hence a marker of endothelial cells and vascular neoplasms. Thromobomodulin is also expressed on mesothelial cells, and may be used as part of a broader panel of antibodies in the distinction of mesothelioma from adenocarcinoma. Subcellular Localization: Membranous
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A dimeric protein produced by and used within the thyroid gland. While it is an excellent marker of metastatic thyroid carcinoma, technical issues with anti-thyroglobulin antibodies, often producing nonspecific signal, make the combination of TTF-1 and PAX-8 expression a better marker of these tumors. Subcellular Localization: Cytoplasmic
Organ: Thyroid
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Identification of toxoplasma organisms. Subcellular Localization: Organisms
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Transthyretin identifies a serum protein produced by the liver and choroid plexus. It forms the basis of one subtype of amyloid, identification of which, and distinction from immunoglobulin light chain derived amyloids, can be made by immunohistochemistry. Transthyretin can also serve as a marker of choroid plexus tumors. Subcellular Localization: Cytoplasmic and in extracellular spaces
Organ:
Disease State: Amyloid Type Analysis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The most abundant secretory granule derived serine proteinase used as a marker of masts cells. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State: Mastocytosis
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The rate limiting enzyme for controlling the production of melanin, and thus a marker of melanocytic cells and tumors. A less sensitive marker of melanoma than gp100 (identified by HMB-45) and MART-1. Subcellular Localization: Cytoplasmic
Organ: Skin & Mucosa
Disease State: Melanoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: Bladder cancer is the fourth most common cancer in the United States. Ninety percent of bladder cancers are classified as Transitional Cell Carcinoma (TCC), which are further categorized into 4 clinically relevant subgroups at pathologic staging. While clinical outcome differs for each subgroup, 3 of the 4 groups are “superficial” at presentation but have a high probability (50-80%) of recurrence, and may progress to invasive tumors. Patients with these superficial bladder cancers are regularly monitored for recurrence and progression, typically with cystoscopy and urine cytology. Both of these methods have shown low sensitivity for detecting bladder cancer; newer studies, however, have shown that FISH analysis for aneuploidy of specific chromosomes may be a useful adjunct in detecting bladder cancer
Organ:
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: 20 mL urine in 10 mL PhenoPath-provided Carbowax fixative (in 50 mL tube) OR at least 20 mL urine Ship immediately on ice. If shipment is delayed, store in refrigerator and ship within 24 hours
CPT Code(s): 88121. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A transmembrane protein that is a specific marker of transitional cell epithelium and tumors. While highly specific, uroplakin is a marker of low sensitivity for urothelial carcinomas. Subcellular Localization: Membranous
Organ: Genitourinary
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Cells infected with varicella zoster virus Subcellular Localization: Membranous, cytoplasmic aggregates
Organ:
Disease State: Identification of Organisms
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: An actin binding protein that is a marker of carcinomas of GI tract origin. Villin, along with CDX2, is a highly specific and fairly sensitive marker of colorectal as well as “noncolorectal GI tract” (e.g., pancreatobiliary tract) derived carcinomas. In the latter tumors, a brush border pattern is characteristic. A subset of lung adenocarcinomas are also villin positive. Subcellular Localization: Cytoplasmic, membranous, “brush border” pattern
Organ: Liver, Colon & Other GI, Pancreas
Disease State: Carcinomas of Unknown Primary
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The intermediate filament protein associated with cells manifesting mesenchymal differentiation; also co-expressed with cytokeratin in a subset of carcinomas. While a subset of carcinomas co-express vimentin along with cytokeratin, the use of organ restricted markers such as TTF-1, PAX-8, etc., is preferred to vimentin in this setting. There are very few remaining applications for use of this antibody in current diagnostic pathology. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Large Cell Undifferentiated Malignant Neoplams
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: Wilms tumor gene product, a marker of ovarian serous carcinoma and mesothelioma. Can be employed as part of a panel of markers in the distinction of mesothelioma from adenocarcinoma, as well as the subclassification of ovarian carcinomas. Subcellular Localization: Nuclear
Organ: Lung, OB/GYN
Disease State: Small, Blue, Round Cell Tumors, Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: Special Stains
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88313. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: ZAP-70, a cytoplasmic protein ubiquitously expressed in T cells and NK cells, and in neoplasms derived from these cells. Most normal B cells do not express ZAP-70, but it is expressed in a variety of B cell non-Hodgkin lymphomas. Importantly, expression of ZAP-70 in chronic lymphocytic leukemia/small lymphocytic lymphoma strongly correlates with a lack in immunoglobulin gene mutation, and has been associated with an adverse prognosis. Subcellular Localization: Cytoplasmic and nuclear
Organ:
Disease State: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: bcl-10 is a sensitive (albeit not highly specific) marker of MALT lymphoma, and may also represent a sensitive and specific marker of pancreatic acinar cell carcinoma. Subcellular Localization: Cytoplasmic
Organ: Pancreas
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies a cytoplasmic/mitochondrial protein that inhibits apoptosis. Bcl-2 is also overexpressed as a result of the t(14;18) in the majority of follicular lymphomas, and in a significant minority of diffuse large B cell lymphomas of germinal center phenotype. Bcl-2 expression in other B cell neoplasms is not associated with the t(14;18). Bcl-2 expression has been observed in the following lymphomas: DLBCL, FL, small lymphocytic (SLL), mantle cell (MCL), marginal zone (MZL), anaplastic large cell (ALCL) and T-cell (TCL). Synovial sarcomas and some muscle-derived tumors also have been shown to express Bcl-2. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Anaplastic Large Cell Lymphoma (Systemic or Cutaneous), Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, T Cell Non-Hodgkin Lymphoma (not otherwise classified)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: C-2 is more sensitive than clone 124 in identifying bcl-2 protein expression in t(14;18)-positive follicular lymphomas. This increased sensitivity is possibly due to C-2 having been raised against a much larger portion of the bcl-2 protein than clone 124. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Follicular Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: A nuclear protein expressed by normal germinal center B cells, by the large majority of follicular lymphomas, by a large subset of diffuse large B cell lymphomas, and by all Burkitt lymphomas. Bcl-6 is also expressed by the neoplastic “popcorn” or “L&H” cells of nodular lymphocyte predominant Hodgkin lymphoma. Subcellular Localization: Nuclear
Organ: Pancreas
Disease State: Angioimmunoblastic T Cell Lymphoma, Burkitt's Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies the protein product of the gene first discovered in Burkitt’s lymphoma, overexpressed as a consequence of chromosomal translocation involving chromosome 8. Used to screen diffuse large B cell lymphomas to identify those with high-level expression, corresponding to those tumors with a relatively high likelihood of harboring a c-MYC gene rearrangement by FISH. Subcellular Localization: Nuclear
Organ:
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88360. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: c-kit, also known as stem cell receptor, is a protein kinase transmembrane receptor that is a marker of gastrointestinal stromal tumors and a mutant form of which is a target of Imatinib therapy. Wild type c-kit expression is present in mast cells, melanocytes, germ cells, glandular epithelium of the breast and salivary gland, and normal interstitial cells of Cajal of the intestine. Subcellular Localization: Membranous
Organ: OB/GYN, Genitourinary, Colon & Other GI
Disease State: Spindle Cell Tumors / Sarcoma Subtyping, Mastocytosis, Germ Cell Tumors
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: p16-INK4A, a tumor suppressor gene that plays an important role in cell cycle regulation. High-risk types of human papillomavirus (HPV) have been associated with increased expression of viral oncogenes E6 and E7, both of which impact various cell cycle regulating proteins. The retinoblastoma gene product is inactivated by E7, resulting in unregulated transcription of p16. Overexpression of the p16 protein has been observed in CIN I, II & III, where it can serve as a surrogate for the presence of high risk HPV types. In the context of head and neck squamous cell carcinomas, p16 overexpression can serve as a prognostic marker. Subcellular Localization: Nuclear and cytoplasmic
Organ: OB/GYN
Disease State:
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: p63 consists of at least two isoforms, TAp63 and ΔNp63. The ΔNp63 isoform (p40) is predominant in basal and myoepithelial cells, as well as squamous cell carcinomas of lung and other sites. The 4A4 anti-p63 clone that has been in use for many years is actually a “pan-p63” antibody, identifying both the ΔNp63 and the TAp63 isoforms. As the TAp63 isoform has a much wider tissue distribution than p40, antibodies to p40 can serve as a more squamous-specific marker, e.g., in the context of lung carcinomas, than the 4A4 "pan p63" antibody. Subcellular Localization: Nuclear
Organ: Lung, Breast, Skin & Mucosa, Prostate
Disease State: Large Cell Undifferentiated Malignant Neoplams, Carcinomas of Unknown Primary, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The p53 gene product, a tumor suppressor gene product which has been referred to as the “guardian of the genome” owing to its role in preventing genome mutation. Overexpression of p53 correlates with the presence of p53 mutations and can serve as a marker of malignancy. Subcellular Localization: Nuclear
Organ: Breast, OB/GYN
Disease State: Diffuse Large B Cell Lymphoma, Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: A paternally imprinted protein, expression of which is lost in cytotrophoblasts of molar pregnancy, i.e., complete mole. The combination of analysis of p57 expression and ploidy (e.g., by FISH) can help define complete moles, incomplete moles, and hydropic normal villi. Subcellular Localization: Nuclear
Organ: OB/GYN
Disease State: Molar Pregnancy
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: p63, a gene in the p53 family, that is expressed in myoepithelial cells, squamous and transitional epithelial cells, and the basal layer of prostate and other epithelial tissues. Identification of p63, or its absence, can be useful in identifying the presence of invasive carcinoma in breast and prostate, as well as the identification of squamous and transitional cell carcinomas. Subcellular Localization: Nuclear
Organ: Lung, Breast, Genitourinary, Skin & Mucosa, Prostate
Disease State: Carcinomas of Unknown Primary, Mesothelioma vs. Adenocarcinoma, Spindle Cell Tumors / Sarcoma Subtyping, Non Small Cell Lung Carcinoma (NSCLC), Breast Cancer
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: The low affinity nerve growth factor receptor, p75-NTR. p75 NTR is a marker of peripheral nerve sheath tumors, and is also expressed in spindle cell melanomas. Subcellular Localization: Membranous and cytoplasmic
Organ:
Disease State: Spindle Cell Tumors / Sarcoma Subtyping
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay detects the chromosomal translocation t(11;14)(q13;q32), which is present in over 95% of mantle cell lymphomas (MCL) and is the most common translocation in multiple myeloma, occurring in 15-25% of cases. This translocation juxtaposes the CCND1 gene with the IGH gene resulting in constitutive overexpression of cyclin D1 protein which leads to deregulated cell cycle control and ultimately tumor cell proliferation. Because of the aggressive nature of mantle cell lymphomas, it is important to identify these lymphomas and differentiate them from other small B cell lymphomas that coexpress CD5 (particularly chronic lymphocytic leukemia/small lymphocytic lymphoma). In addition, patients with multiple myeloma that have a t(11;14)(q13;q32) have been reported to have a neutral to slightly improved clinical course. Probe type: Dual color, dual fusion translocation
Organ: Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma, Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: The t(11;18)(q21;q21), which juxtaposes the MALT1 gene located on chromosome 11q21 with the API2 (also known as BIRC3) gene on 18q21, is detected in approximately 10-20% of patients with extranodal low grade marginal zone B-cell lymphomas of MALT type (i.e., MALT lymphomas) and is particularly prevalent in those of gastric (20-30%) and lung (~50%) origin. It is of particular clinical import as patients with t(11;18)(q21;q21)-positive gastric MALT lymphomas do not respond to Helicobacter pylori eradication therapy, are associated with more advanced-stage disease, and usually do not show transformation to large cell lymphoma. Probe type: Dual color, dual fusion translocation
Organ: Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Marginal Zone/MALT Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay detects the t(14;16)(q32;q23) which juxtaposes the CMAF gene with the IGH gene. This translocation has been identified as a recurrent and prognostic translocation in plasma cell myeloma and has been associated with a poor prognosis with shorter overall survival. Plasma cell myeloma is a bone marrow-based plasma cell proliferation characterized by elevated circulating monoclonal paraprotein production and multifocal osteolytic bone lesions. Separation of plasma cell myeloma into different subgroups based upon recurrent chromosomal alterations may provide important prognostic information and may provide the basis for particular therapy for some plasma cell myeloma subgroups. Probe type: Dual color dual fusion translocation
Organ: Brain/CNS, Blood/Bone Marrow, Body Fluids
Disease State: Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay specifically detects the t(14;18)(q32;q21) involving the BCL2 and IGH chain genes. This translocation is present in over 90% of follicular lymphomas and in a significant minority (20-30%) of diffuse large B cell lymphomas. It is characterized by the aberrant juxtaposition of the BCL2 proto-oncogene on chromosome 18 with the immunoglobulin heavy chain gene on chromosome 14, resulting in constitutive overexpression of the BCL2 protein which ultimately leads to alterations in programmed cell death (i.e., apoptosis) and tumor cell proliferation. Evaluation for a t(14;18)(q32;q21) is of use in the diagnostic evaluation for follicular lymphoma as well as in the evaluation of aggressive B cell lymphomas where Burkitt's lymphoma (BL), diffuse large B cell lymphoma (DLBCL), and the intermediate category are diagnostic considerations. In aggressive B cell lymphoma, the presence of a t(14;18)(q32;q21) in addition to a MYC rearrangement argues against the diagnosis of BL. The presence of a t(14;18)(q32;q21) is seen more often in DLBCLs of germinal center cell type and has been reported to be a poor prognostic factor in some studies. Probe type: Dual color, dual fusion translocation
Organ: Skin & Mucosa, Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Burkitt's Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This dual color dual fusion FISH assay secifically detects the t(14;18)(q32;q21). This translocation, which juxtaposes the MALT1 gene on chromosome 18q21 with the IGH chain gene on 14q32, is detected in approximately 10% of patients with MALT lymphomas, namely in MALT lymphomas of the liver, skin, ocular adnexa, and salivary gland, but typically does not occur in MALT lymphomas of the stomach, intestine, lung, thyroid, or breast. Probe type: Dual color, dual fusion translocation
Organ: Blood/Bone Marrow, Colon & Other GI, Body Fluids, Lymph Node / Spleen
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified), Marginal Zone/MALT Lymphoma
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded tissue block or cell block - OR - • Minimum of 5 unstained slide cut at 4µm for each test requested
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay detects the t(15;17)(q22;q12) involving the PML and RARA genes. It is the most common translocation for acute promyelocytic leukemia (AML-M3) which is a distinct form of acute myeloid leukemia that accounts for approximately 10% of cases and is characterized by promyelocytes, thrombocytopenia, disseminated intravascular coagulation (DIC), and sensitivity to all-trans-retinoic acid (ATRA). Probe type: Dual color dual fusion translocation
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes, Acute Promyelocytic Leukemia
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay detects the t(4;14)(p16;q32) which juxtaposes the FGFR3 gene with the IGH gene. This translocation has been identified as a recurrent and prognostic translocation in plasma cell myeloma and has been associated with a poor prognosis with shorter overall survival. Plasma cell myeloma is a bone marrow-based plasma cell proliferation characterized by elevated circulating monoclonal paraprotein production and multifocal osteolytic bone lesions. Separation of plasma cell myeloma into different subgroups based upon recurrent chromosomal alterations may provide important prognostic information and may provide the basis for particular therapy for some plasma cell myeloma subgroups. Probe type: Dual color, dual fusion translocation
Organ: Brain/CNS, Blood/Bone Marrow, Body Fluids
Disease State: Plasma Cell Myeloma/Neoplasm
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance:
Organ:
Disease State:
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: FISH studies for t(8;21) are clinically indicated in new diagnoses of acute myeloid leukemia (AML) for proper diagnostic classification, as the t(8;21) is a recurrent chromosomal abnormality in AML. FISH testing for this abnormality may also be indicated for follow-up studies to monitor disease progression and response to therapy. t(8;21)(q22;q22) is the most frequently observed karyotypic abnormality associated with acute myeloid leukemia (AML), especially in FAB M2. Clinically, this type of AML is found in 5-12% of AML, often shows eosinophilia, and has a high complete remission rate with conventional chemotherapy. Probe type: Dual fusion, dual color
Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen
Disease State: Acute Myeloid Leukemia (AML) / Myeloid Sarcoma, Myelodysplastic Syndromes
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: FISH
Clinical Significance: This FISH assay detects the t(9;22), which results in the BCR-ABL fusion gene. The hallmark of chronic myelogenous leukemia (CML) is the presence of the BCR-ABL fusion gene associated with the Philadelphia chromosome (Ph). All cases of CML have a t(9;22) or variant and detection of this genetic abnormality is important in the diagnosis of CML. The BCR/ABL fusion gene resulting from the t(9;22) is the target for the tyrosine kinase inhibitor drug imatinib. Probe type: Dual color dual fusion translocation
Organ: Blood/Bone Marrow, Body Fluids
Disease State: Precursor B-Lymphoblastic Lymphoma/Leukemia (B-ALL), Myeloproliferative Neoplasms, Including Chronic Myelogenous Leukemia (CML)
Turnaround Time: Within 4-6 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Peripheral blood, Preferred: 3 ml in sodium heparin (green top) / Acceptable: 3 ml in EDTA (purple top) - OR - • Bone marrow aspirate, Preferred: 1-2 ml in sodium heparin (green top) / Acceptable: 1-2 ml in EDTA (purple top) - OR - • Fresh tissue in RPMI - OR - • Formalin-fixed, paraffin-embedded tissue (FFPE)
CPT Code(s): 88374. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Methodology: IHC
Clinical Significance: Identifies: von Willebrand factor (often erroneously referred to as "Factor VIII") is synthesized by endothelial cells and stored in the Weibel-Palade granules. von Willebrand factor can be employed as a marker of vascular neoplasms as well as a marker of megakaryocytic differentiation. Subcellular Localization: Cytoplasmic
Organ:
Disease State: Spindle Cell Tumors / Sarcoma Subtyping, Acute Myeloid Leukemia (AML) / Myeloid Sarcoma
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
Specimen Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm
CPT Code(s): 88342 or 88341. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.