Companion Diagnostic for BRAF V600E Mutation

October 2011, Vol 2, No 6 - FDA Approvals, News & Updates

Along with vemurafenib the FDA concurrently approved the companion molecular diagnostic for this targeted therapy—the cobas 4800 BRAF V600 Mutation Test (Roche) for the diagnosis of BRAF V600E mutation in patients with melanoma. As a realtime polymerase chain-reaction test, it is 97.3% positive in detecting the mutation. (August 17, 2011)