TEST:

CRCdx® RAS Mutation Detection Kit

CRCdx® RAS Mutation Detection Kit is a qualitative real-time PCR in vitro diagnostic test intended for the detection of 35 variants of KRAS and NRAS exon 2, 3, 4 somatic mutations in genomic DNA extracted from formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples. The test is intended as a companion diagnostic (CDx) to aid in the identification of colorectal cancer (mCRC) patients who may benefit from treatment with Vectibix (panitumumab) based on a no mutation detected test result in accordance with the approved therapeutic product labeling.