570203: KRAS Gene Extended Mutation Analysis

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. 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. 20921465

Karachaliou N, Mayo C, Costa C, et al. KRAS mutations in lung cancer. Clin Lung Cancer. 2013 May;14(3):205-214. 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.

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