The Food and Drug Administration has approved the Cobas KRAS Mutation Test for diagnostic use to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer to help clinicians determine the best therapy. The test is a TaqMelt assay, which is a polymerase chain reaction (PCR)-based diagnostic test intended for the detection of mutations in codons 12 and 13 of the KRAS gene.
The test can be performed in less than eight hours; and it is intended to be used as an aid in the identification of patients with metastatic colorectal cancer for whom treatment with cetuximab or panitumumab may be effective if no KRAS mutation is present.
The test is performed using the Cobas 4800 System, which is also used for performing the Cobas BRAF V600 Mutation Test (approved in 2011, OT 9/10/11 issue) and the Cobas EGFR Mutation Test (approved in 2013, OT 6/10/13 issue). All three tests are marketed by Roche.