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RAS Launch Notification

KRAS cobas® IVD   - & -   Extended RAS Panel

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 (see reference below).  These consensus testing recommendations state that 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’s updated RAS testing menu includes the FDA-approved cobas® KRAS Mutation Test, which detects KRAS codon 12 and 13 mutations, and our extended RAS assay which utilizes a pyrosequencing based method to detect mutations in the remaining KRAS and NRAS codons listed above.  The FDA-approved Roche cobas® KRAS assay replaces PhenoPath’s prior KRAS codon 12/13 testing with the Qiagen therascreen® KRAS RGQ assay and similarly detects the seven most common KRAS exon 2 mutations.

PhenoPath recommends ordering RAS mutation testing in a reflexive manner, starting with the 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. 

Please contact Sheri Storey by email (sheri@phenopath.com) or cell (206-694-3418), call PhenoPath’s Client Services department (206-374-9000), or visit www.phenopath.com, for more information.

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):187-225.

 

Related articles:

KRAS cobas® IVD

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):187-225.

CPT Code(s): 81275; 88381 may apply (reference only; CPTs may vary)

Turnaround Time: Within 3-6 business days of receipt

Schedule: Monday & Thursday

Specimen Requirements: 
Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)

 

Extended RAS Panel

Methodology:  Pyrosequencing/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. 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.  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.

CPT Code(s): 81276, 81311; 88381 may apply (reference only; CPTs may vary)

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)

PhenoPath, PLLC

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