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KRAS Gene Extended Mutation Analysis

CPT To be determined. Updates will be made when available.

Test Details

Turnaround Time

5 - 7 days

View Requisition Forms

Use

KRAS is a guanosine triphosphate (GTP) binding protein involved in downstream receptor signaling, which is critical for cell proliferation, survival and differentiation. Mutations in the KRAS oncogene are frequently found in human cancers. They are common in pancreatic, colorectal, lung, gallbladder, bile duct and thyroid cancer. This assay will detect KRAS mutations in exons 2, 3 and 4, allowing the determination of drug response.

Special Instructions

Provide a copy of the pathology report; the KRAS test will be delayed if the pathology report is not received. Direct any questions regarding this test to customer service at 800-345-4363.

Limitations

This assay is able to detect 5% mutation in a background of wild-type DNA.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Methodology

SNaPshot Multiplex PCR (primer extension-based method)

References

Bokemeyer C, Van Cutsem E, Rougier P, et al. Addition of cetuximab to chemotherapy as first-line treatment for KRAS wild-type metastatic colorectal cancer: Pooled analysis of the CRYSTAL and OPUS randomised clinical trials. Eur J Cancer. 2012 Jul;48(10):1466-1475. PubMed 22446022
Douillard JY, Siena A, Cassidy J, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: The PRIME study. J Clin Oncol. 2010 Nov 1;28(31):4697-4705. PubMed 20921465
Karachaliou N, Mayo C, Costa C, et al. KRAS mutations in lung cancer. Clin Lung Cancer. 2013 May;14(3):205-214. PubMed 23122493
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer v2.2015. Fort Washington, Pa: NCCN; 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer v3.2015. Fort Washington, Pa: NCCN; 2015.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer v2.2015. Fort Washington, Pa: NCCN; 2015.

Specimen Requirements

Information on collection, storage, and volume

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides

Volume

Formalin-fixed, paraffin-embedded tissue block or four unstained slides and one matching H&E-stained slide at 5 µM

Minimum Volume

Two unstained slides and one matching H&E-stained slide at 5 μM (samples with >4 mm² and ≥50% tumor content are preferred)

Container

FFPE tissue blocks or slides

Storage Instructions

Maintain blocks and slides at room temperature.

Causes for Rejection

Tumor block containing no tumor tissue; broken or stained slides

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