Biocartis Idylla KRAS Mutation Test

The Idylla™ KRAS Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of mutations in codons 12, 13, 59, 61, 117 or 146 of the KRAS oncogene. The Idylla™ KRAS Mutation Test, from sample to result, starts with formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer (CRC) tissue to liberate DNA for subsequent real-time PCR amplification and detection. The Idylla™ KRAS Mutation Test is intended to determine the tumor KRAS mutation status of patients with metastatic colorectal cancer at diagnosis and to facilitate treatment decisions within a multidisciplinary team. The Idylla™ KRAS Mutation Test is not intended to diagnose colorectal cancer.