RAS/RAF Pathway Mutation Profile (KRAS and NRAS reflex to BRAF)

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

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

Four unstained slides at 5 μM and one matching H&E-stained slide

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

KRAS and NRAS are guanosine triphosphate (GTP)-binding proteins involved in downstream receptor signaling, which is critical for cell proliferation, survival and differentiation. Mutations in the KRAS and NRAS oncogene are frequently found in human cancers. They are common in pancreatic, colorectal, lung, bile duct, and thyroid cancer, as well as in melanomas. BRAF is an important member of the mitogen-activated protein kinase (MAPK) pathway that influences cell proliferation. Mutations in the BRAF oncogene are frequently found in human cancers, such as melanoma, colorectal cancer, lung cancer, ovarian cancer, thyroid cancer, and hairy cell leukemia. This assay detects KRAS and NRAS mutations in exons 2, 3, and 4, BRAF V600 mutations, allowing the determination of drug response.

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 US Food and Drug Administration (FDA).

SNaPshot Multiplex PCR (primer extension-based method)