KRAS Gene Extended Mutation Analysis

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

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

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

FFPE tissue blocks or slides

Maintain blocks and slides at room temperature.

Tumor block containing no tumor tissue; broken or stained slides

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.

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.

SNaPshot Multiplex PCR (primer extension-based method)