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News & Info

PhenoPath launches first-ever NGS assay

Company News

Please read the attached letter for additional information.

PhenoPath conference March 7th

Company News

Please read the attached letter regarding the PhenoPath conference scheduled for March 7th, 2019

PhenoPath acquired by Quest Diagnostics

Newsletters

Please read the attached letter for an important announcement regarding PhenoPath

Phenomena v21.1

Newsletters

New FDA Approvals for PD-L1/PD-1 Targeted Therapies & Introducing the Combined Positive Score (CPS); New Assays MUC4 IHC and TFE3 (Xp11) FISH; Amyloid Analysis; etc.

Phenomena v20.2 (Fall 2017)

Newsletters

PhenoPath newsletter featuring the latest on RAS gene testing, "double-hit" B cell lymphomas, and a new marker for small cell carcinoma of the ovary.

RAS Launch Notification

Company News

PhenoPath is pleased to announce the launch of extended RAS gene testing. Beginning June 5, 2017, PhenoPath will offer in-house KRAS and NRAS testing that complies with the joint guidelines recently issued by ASCP, CAP, AMP and ASCO

Roche cobas® EGFR Plasma Mutation Test

Company News

PhenoPath now offers EGFR mutation testing using cell-free DNA isolated from plasma.

Roche cobas® EGFR Mutation Test

Company News

PhenoPath is pleased to offer the Roche cobas® EGFR Mutation Test (v2), the only FDA-approved IVD assay for the detection of T790M, Exon 19 deletion, and L858R EGFR mutations in DNA isolated from formalin fixed paraffin embedded tumor tissue (FFPE) or in cell-free/circulating tumor DNA from plasma.

Phenomena v20.1 (Winter 2017)

Newsletters

PD-L1 Testing Update, Plasma Based “Liquid Biopsy” Testing for EGFR Mutations, HER2 Clone 4B5, H3K27me3, PhenoPath at USCAP and NCCN, and more!

PD-L1 IHC 28-8 pharmDx

Company News

PhenoPath is pleased to announce the availability of the PD-L1 IHC 28-8 pharmDx, the only FDA-approved test for PD-L1 expression associated with enhanced survival with OPDIVO® (nivolumab) for non-squamous NSCLC.

PD-L1 IHC 22C3 pharmDx

Company News

PhenoPath is proud to announce the release of FDA-approved PD-L1 IHC 22C3 pharmDx, for the semi-quantitative assessment of PD-L1 expression in non-small cell lung carcinomas (NSCLC).

Phenomena v19.2 (Summer 2016)

Newsletters

PD-L1 Update, Flow Cytometry, Kappa / Lambda ISH, Molecular Testing in Colorectal Carcinoma, Webinar, and more!

Phenomena v19.1 (Spring 2016)

Newsletters

PhenoPath at USCAP, Open House Event, PD-L1 (22C3 and 28-8) and EGFR T790M testing at PhenoPath, BAP1 and P16 FISH in malignant mesothelioma, and more!

ICD-10 Go-Live

Company News

Read more about the ICD-9 to ICD-10 conversion.

Lung Fluid Versus Tissue Biopsy for Mesothelioma Diagnosis

Company News

The pathologists from PhenoPath and the University of British Columbia found that certain genetic alterations were seen just as often in the fluid samples of mesothelioma patients as they were in tissue samples.

PhenoPath Offering PD-L1

Company News

Evaluation of Human Epidermal Growth Factor Receptor 2 (HER2) Gene Status in Human Breast Cancer

Publications

Evaluation of Human Epidermal Growth Factor Receptor 2 (HER2) Gene Status in Human Breast Cancer Formalin-Fixed Paraffin-Embedded (FFPE) Tissue Specimens by Fluorescence In Situ Hybridization (FISH)

Utility of BAP1 Immunohistochemistry and p16 (CDKN2A) FISH

Publications

Utility of BAP1 Immunohistochemistry and p16 (CDKN2A) FISH in the Diagnosis of Malignant Mesothelioma in Effusion Cytology Specimens

Markers of metastatic carcinoma of breast origin

Publications

This review summarizes the three major breast-associated markers that can be of assistance in evaluating metastatic carcinomas for which a breast primary diagnosis is entertained.

Vascular mesangial channels in human nodular diabetic glomerulopathy

Publications

The presence of vascular mesangial channels has been reported in idiopathic nodular glomerulosclerosis and diabetic glomerulopathy. However, only limited information on the morphology and immunohistochemical phenotype of these channels is available.

Practical Applications in Immunohistochemistry: Carcinomas of Unknown Primary Site

Publications

Context .- Identification of the site of origin of carcinoma of unknown primary using immunohistochemistry is a frequent requirement of anatomic pathologists. Diagnostic accuracy is crucial, particularly in the current era of targeted therapies and smaller sample sizes.

Comparative Sensitivities and Specificities of Antibodies to Breast Markers GCDFP-15, Mammaglobin A

Publications

Comparative Sensitivities and Specificities of Antibodies to Breast Markers GCDFP-15, Mammaglobin A, and Different Clones of Antibodies to GATA-3: A Study of 338 Tumors Using Whole Sections

Personalized oncogenomics: clinical experience with malignant peritoneal mesothelioma

Publications

Personalized oncogenomics: clinical experience with malignant peritoneal mesothelioma using whole genome sequencing

BAP1 immunohistochemistry and p16 FISH to separate benign from malignant mesothelial proliferations

Publications

A variety of immunohistochemical (IHC) stains have been proposed to mark either benign or malignant mesothelial proliferations. Loss of the p16 tumor suppressor (CDKN2A), through homozygous deletions of 9p21, is a good marker of mesotheliomas but lacks sensitivity.

Phenomena v18.2 (Fall 2015)

Newsletters

PhenoPath Cytogenetics / New IHC Markers in Hematologic Diseases and Solid Tumors / Recent Publications

The lung-restricted marker napsin A is highly expressed in clear cell carcinomas of the ovary

Publications

OBJECTIVES: We recently observed expression of the "lung" marker napsin A in ovarian clear cell carcinomas and therefore sought to determine the extent of napsin A expression in a subset of ovarian neoplasms.

GATA-3 expression in trophoblastic tissues

Publications

GATA-3 expression in trophoblastic tissues: an immunohistochemical study of 445 cases, including diagnostic utility.

Phenomena v18.1 (Winter 2015)

Newsletters

Technical FISH Services Available / New Publications / New IHC Antibodies / Etc.

PhenoUpdate (September 2014)

Newsletters

New Tests / Tests Under Development / Important Test Utilization and Reporting News / Etc.

Phenomena Volume 17 No. 3 (Summer 2014)

Newsletters

Lynch Syndrome Algorithm / 1q21+1p21 in Multiple Myeloma / PhenoPath Introduces Multiplex Assays / AJSP publication / Etc.

PhenoUpdate (July 2014)

Newsletters

New Tests / Tests Under Development / Important Test Utilization and Reporting News / Etc.

PhenoUpdate (May 2014)

Newsletters

New Tests and Panels / Tests Under Development / Specimen Requirement Changes

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Phenomena Volume 17, No. 2 (Spring 2014)

Newsletters

PhenoPath Supports African Burkitt Lymphoma Projects / MSI Testing by PCR / FUS (16p11) translocations / Lung and Breast Flier Release / New Heme Antibodies

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PhenoPath Adopts 2013 Updated ASCO-CAP HER2 Testing Guidelines in Breast Cancer

Company News

PhenoPath is one of the first labs in the US to adopt all the complex changes of the 2013 American Society of Clinical Oncology and College of American Pathologists (ASCO-CAP) HER2 Testing Guideline updates in breast cancer.

PhenoUpdate (Spring 2014)

Newsletters

New Tests and Panels / Tests Under Development / Specimen Requirement Changes

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Phenomena Volume 17, No. 1 (Winter 2014)

Newsletters

2013 Updated ASCO-CAP HER2 Testing Guidelines in Breast Cancer/PhenoPath at the USCAP/Three Robust Antibodies in Classification of Low-Grade B Cell Lymphomas

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PhenoPath is pleased to announce MSI by PCR

Company News

Hereditary non-polyposis colorectal carcinoma (HNPCC), also known as Lynch Syndrome, is an autosomal dominant hereditary cancer syndrome associated with germline mutations in one of the mismatch repair (MMR) genes (MLH1, MSH2, MSH6, and PMS2).

Phenomena Volume 16, No. 3 (Autumn 2013)

Newsletters

Regan Fulton, MD, PhD, Joins PhenoPath / ROS1 FISH / GATA-3: a novel marker of breast and urothelial carcinomas / PhenoCases

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Phenomena Volume 16, No. 2 (Summer 2013)

Newsletters

Harvey Greisman, MD, PhD, Joins PhenoPath / AML FISH Panel / New Crop of IHC Markers Now Available / 10-Color Flow Cytometers

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Phenomena Volume 16, No. 1 (Spring 2013)

Newsletters

PhenoPath at USCAP / New Test KRAS Therascreen IVD / MDS Panel

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FDA-approved Therascreen® KRAS mutation in vitro diagnostic (IVD) test for colorectal adenocarcinoma

Company News

PhenoPath Laboratories is pleased to announce that we are offering the FDA-approved Therascreen® KRAS mutation in vitro diagnostic (IVD) test for colorectal adenocarcinoma.

PhenoPath Laboratories Releases the 7th Edition of Its “Pathology Reference Guide”

Company News

PhenoPath Laboratories has released the much-awaited 7th Edition of its Pathology Reference Guide, a comprehensive overview of all the immunohistochemistry, flow cytometry, and molecular (PCR based and FISH based) testing offered by PhenoPath Laboratories.

IMP3 and GLUT-1 Immunohistochemistry for Distinguishing Benign From Malignant Mesothelial Proliferations

Publications

Distinguishing malignant mesotheliomas from benign mesothelial proliferations on hematoxylin and eosin-stained sections can be extremely challenging. Various immunohistochemical stains have been suggested to help in making this distinction, but all are controversial.

Phenomena Volume 15, No. 3 (Winter 2012)

Newsletters

New Web Site / Pathology Reference Guide Released / New Tests Available (IDH1, PTEN, CD42b, CD61, CD71, cobas® 4800 BRAF V600E)

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Immunohistochemistry as an adjunct in the differential diagnosis of radiation-induced atypia versus urothelial carcinoma in situ of the bladder

Publications

Muscle invasive urothelial carcinoma has been treated with cystectomy ± adjuvant therapy. Recently, a bladder-sparing protocol has been offered to selected patients closely followed with surveillance biopsies. In this setting, radiation-induced changes (RAD-Ch) may be very difficult to distinguish from carcinoma in situ, and failing to recognize them may lead to overtreatment.

PhenoPath Launches New Website

Company News

PhenoPath Laboratories is pleased to announce the launch of their newly designed website: www.phenopath.com, which goes live on Monday, November 19, 2012. The new design advances our mission to provide “Diagnoses you can count on^®” by providing our customers access to extensive diagnostic pathology reference and referral resources.

PhenoPath Laboratories Publishes JCO Article on New Breast Cancer Testing Protocol

Company News

A new laboratory testing protocol can more accurately identify an important group of breast cancer patients who are most likely to benefit from a “targeted therapy” shown to dramatically improve survival.

Flow cytometric principles in hematopathology.

Publications

Dr. Kussick authored the chapter "Flow Cytometric Principles in Hematopathology" in Hematopathology, 2nd Edition, ed. by E. Hsi, series ed. J.R. Goldblum. Philadelphia, PA, Saunders, Elsevier, Chapter 23, 2012. This chapter is divided into five major sections.

Concordance between human epidermal growth factor receptor 2 testing by reverse transcriptase polymerase chain reaction and fluorescent in situ hybridization.

Publications

Dabbs et al1 reported a study of human epidermal growth factor receptor 2 (HER2) status in a series of patients with breast cancer, comparing results via fluorescent in situ hybridization (FISH) and reverse transcriptase polymerase chain reaction (RT-PCR), the latter employing the Oncotype DX assay (Genomic Health, Redwood City, CA).

Comparison of clot-based vs. chromogenic factor Xa procoagulant phospholipid activity assays.

Publications

We compared 2 commercial plasma procoagulant phospholipid activity (PPA) assays, chromogenic, using bound annexin V to capture phosphatidylserine-containing microparticles, and clot-based. In both, anionic phospholipids accelerated activation of prothrombin by factor Xa. PPA levels were lower in the chromogenic vs the clot-based assay, with poor correlation between methods:

Carcinoma of the collecting ducts of Bellini and renal medullary carcinoma: clinicopathologic analysis of 52 cases of rare aggressive subtypes of renal cell carcinoma with a focus on their interrelationship.

Publications

Carcinoma of the collecting ducts of Bellini and renal medullary carcinoma are rare aggressive neoplasms of putative distal nephron origin. First described in 1949, case reports and review articles constitute a major source of information on collecting duct carcinoma, whereas Davis and colleagues and the pediatric tumor registry have contributed the seminal works on renal medullary carcinoma. Here we present a detailed study of collecting duct carcinoma (n=39) and renal medullary carcinoma (n=13), characterizing these rare neoplasms and analyzing their interrelationship.

Guidelines for Pathologic Diagnosis of Malignant Mesothelioma: 2012 Update of the Consensus Statement from the International Mesothelioma Interest Group

Publications

Context.-Malignant mesothelioma (MM) is an uncommon tumor that can be difficult to diagnose. Objective.-To provide updated practical guidelines for the pathologic diagnosis of MM. Data Sources.-Pathologists involved in the International Mesothelioma Interest Group and others with an interest in the field contributed to this update. Reference material includes peer-reviewed publications and textbooks.

Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen.

Publications

Neoadjuvant IRX-2 immunotherapy regimen may restore immune responsiveness presumably by mobilizing tumor infiltrating effector lymphocytes and macrophages into the tumor.

Pulmonary hyalinizing granuloma with associated elevation in serum and tissue IgG4 occurring in a patient with a history of sarcoidosis.

Publications

This case provides the first definitive evidence that PHG is part of the spectrum of IgG4-related sclerosing disease.

PhenoPath Retests Nearly 3,000 Breast Cancer Specimens

Company News

Seattle-based PhenoPath Laboratories served as the reference laboratory for a highly anticipated retesting of nearly 3,000 breast cancer specimens from the Province of Quebec, results of which were announced by Quebec Health Minister Yves Bolduc this week.

Phenomena Volume 15, No. 2 (Spring 2012)

Newsletters

Major & Minor BCR-ABL1 RNA and JAK2 V617F Testing by PCR / Other New Test Offerings
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Routine pathologic parameters can predict Oncotype DX recurrence scores in subsets of ER positive patients: who does not always need testing?

Publications

When cost and time are a consideration and the added value of Oncotype DX^® testing is in question, it may be reasonable to assume the results of this test in two specific subsets of breast cancers: (1) grade 1, high PR, low Ki67 cancers (low RS), and (2) grade 3, low PR, high Ki67 cancers (high RS).

Phenomena Volume 15, No. 1 (Winter 2012)

Newsletters

HER2 Testing Protocol / FDA-Approved ALK FISH / Other New Test Offerings
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Determining true HER2 gene status in breast cancers with polysomy by using alternative chromosome 17 reference genes: implications for anti-HER2 targeted therapy.

Publications

Additional FISH studies that use probes to the SMS, RARA and TP53 genes are an effective way to determine the true HER2 amplification status in patients with polysomy 17, and they have important potential implications for guiding HER2-targeted therapy in breast cancer.

The knowns and the unknowns in HER2 testing in breast cancer

Publications

The 2007 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for HER2 immunohistochemical and fluorescence in situ hybridization (FISH) testing in breast cancer address the potential impact of several “knowns” (eg, effect of fixative composition and fixation time).1,2 However, data continue to be generated that shed further light on the impact of “unknowns,” ie, selected preanalytic, analytic, and postanalytic (ie, interpretive) factors, on HER2 immunohistochemical testing.

Immunophenotyping of thyroid tumors identifies molecular markers altered during transformation of differentiated into anaplastic carcinoma.

Publications

The markers observed to change during thyroid cancer progression validate prior observations and represent promising molecular diagnostic or prognostic tools and identify targets for therapy of ATC.

Best practices in diagnostic immunohistochemistry: myoepithelial markers in breast pathology.

Publications

To demonstrate the presence or absence of myoepithelial cells, a panel-based approach of 2 or more markers is recommended.

Phenomena Volume 14, No. 2 (Spring 2011)

Newsletters

Myeloma FISH Panel / HER2 Assessment in Breast Cancer via FISH and RT-PCR / Subclassifying Lung Carcinoma / TTF-1 Expression in Breast Cancer
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Effect of Xpcl1 activation and p27 (Kip1) loss on gene expression in murine lymphoma PLoS One 11: 6(3): e14758

Publications

Mice lacking the p27(Kip1) Cdk inhibitor (Cdkn1b) exhibit increased susceptibility to lymphomas from the Maloney murine leukemia virus (M-MuLV), and exhibit a high frequency of viral integrations at Xpcl1 (Kis2), a locus on the X-chromosome. Xpcl1 encodes miR-106a~363, a cluster of microRNAs that are expressed in response to adjacent retroviral integrations.

Pure epithelioid PEComas (so-called epithelioid angiomyolipoma) of the kidney: A clinicopathologic study of 41 cases: detailed assessment of morphology and risk stratification.

Publications

Our data of a large series with uniform definitional criteria confirm the malignant potential for pure epithelioid PEComas and provide adverse prognostic parameters for risk stratification in these patients.

Phenomena Volume 14, No. 1 (Winter 2011)

Newsletters

Kappa Light Chain PCR / Brachyury IHC / Other New Test Offerings
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Thyroid transcription factor-1 expression in breast carcinomas.

Publications

We conclude that a small proportion of breast carcinomas show TTF-1 expression. Therefore, the presence of TTF-1 immunoreactivity in a carcinoma cannot by itself be used to exclude the possibility of a breast origin.

Optimal immunohistochemical markers for distinguishing lung adenocarcinomas from squamous cell carcinomas in small tumor samples.

Publications

We present an algorithm for the stepwise application of p63, TTF1, CK5/6, CK7, Napsin A, and mucicarmine in situations in which separation of ADC from SCC in small specimens cannot be accomplished by morphology alone.

Phenomena Volume 13, No. 3 (Fall 2010)

Validation of ER/PR IHC per ASCO-CAP Guidelines / KRAS Mutation Analysis by PCR / Other New Test Offerings
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Human epidermal growth factor receptor 2 assessment in a case-control study: comparison of fluorescence in situ hybridization and quantitative reverse transcription polymerase chain reaction performed by central laboratories.

Publications

There is a high degree of concordance between central FISH and quantitative RT-PCR using Oncotype DX for HER2 status, and the assay warrants additional study in a trastuzumab-treated population.

Phenomena Volume 13, No. 3 (Fall 2010)

Newsletters

Validation of ER/PR IHC per ASCO-CAP Guidelines / KRAS Mutation Analysis by PCR / Other New Test Offerings
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Positive response to neoadjuvant cyclophosphamide and doxorubicin in topoisomerase II nonamplified/HER2/neu negative/polysomy 17 absent breast cancer patients.

Publications

We observed substantial treatment response in patients lacking three postulated predictors that would be difficult to attribute to cyclophosphamide alone. Patients who are HER2 negative and lack TOP2A amplification and PS17 should not be excluded from receiving DOX-containing regimens.

Phenomena Volume 13, No. 2 (June 2010)

Newsletters

Announcing 10-Color Flow Cytometry / New ASCO-CAP Guidelines for ER/PR / CLL/SLL FISH
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Diagnostic utility of galectin-3 in thyroid cancer.

Publications

The development of Gal-3 as a diagnostic marker for thyroid cancer represents a promising avenue for future study, and its clinical application could significantly reduce the number of diagnostic thyroid operations performed for cases of indeterminant fine needle aspiration biopsy cytology, and thus positively impact the current management of thyroid nodular disease.

Fibrillins in human adult ovary and polycystic ovary syndrome: is fibrillin-3 affected in PCOS?

Publications

Polycystic ovary syndrome (PCOS) is a common endocrinopathy in women of reproductive age.

Phenomena Volume 13, No. 1 (February 2010)

Newsletters

Subclassification of DLBCL by IHC / Anti-bcl-2 Clone C2 / 3,000 Breast Cancers Retested by PhenoPath
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Phenomena Volume 12, No. 4 (November 2009)

Newsletters

EGFR Mutation Analysis by PCR / Diagnosing Mesothelioma / Other New Test Offerings
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Phenomena Volume 12, No. 3 (Winter 2009)

Newsletters

Test Validation / SMS/RARA FISH / DOG1 IHC / Recent Publications
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Phenomena Volume 12, No. 2 (May 2009)

Newsletters

New Tests Available at PhenoPath (PAX8 and MDM2 by IHC; BRAF by PCR)
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Phenomena Volume 12, No. 1 (January 2009)

Newsletters

KRAS Testing for Colorectal Tumors / Landmark HER2 Testing Concordance Study Published
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Phenomena Volume 11, No. 3 (October 2008)

Newsletters

Carcinomas of Unknown Primary Markers / New Test Offerings / Optimal Specimen Handling for Myeloid Stem Cell Neoplasms
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Phenomena Volume 11, No. 2 (June 2008)

Newsletters

Carcinomas of Unknown Primary Panel Selection / Other New Test Offerings / Optimal Specimen Handling for Lymphoma and/or Plasma Cell Dyscrasia
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Phenomena Volume 11, No. 1 (February 2008)

Newsletters

PhenoPath at the USCAP Meeting / Best Practices Guides to Diagnostic Immunohistochemistry
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Phenomena Volume 10, No. 4 (November 2007)

Newsletters

t(9;22) BCR/ABL & RARA Breakapart FISH / PhenoPath's HER2 QA Program / Recent Publications
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Phenomena Volume 10, No. 3 (July 2007)

Newsletters

HER2 Testing Validation / Molar Pregnancies / Recent Publications
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Phenomena Volume 10, No. 2 (April 2007)

Newsletters

Introducing PhenoNet (PhenoPath's web-based reporting tool) / Making Urgent Diagnoses in Hematopathology / HER2 Validation Studies / New Test Offerings
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Phenomena Volume 10, No. 1 (February 2007)

Newsletters

ASCO-CAP HER2 Testing Guidelines / Landmark Study on Estrogen Receptor IHC Testing / HER2 Reflex Testing and Concordance Studies / CLL/SLL FISH
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Phenomena Volume 9, No. 4 (Fall 2006)

Newsletters

Intracystic Papillary Carcinomas / TOP2A FISH Studies / Tissue Fixation / B and T Cell by PCR
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Phenomena Volume 9, No. 3 (Summer 2006)

Newsletters

Direct and Indirect Clonality Testing at PhenoPath (by IHC, FISH, Flow and PCR)
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Phenomena Volume 9, No. 2 (Spring 2006)

Newsletters

Mesothelioma Study Published / Specialized Dermatopathology Services
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Phenomena Volume 9, No. 1 (Winter 2006)

Newsletters

PhenoPath at USCAP / FISH Studies for Oligodendrogliomas / Launch of Flow Cytometry Service / New Test Offerings
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