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ARTICLE | Clinical News

cobas KRAS Mutation Test regulatory update

October 7, 2013 7:00 AM UTC

The U.K.'s NICE issued draft guidance recommending 2 PCR-based tests to determine K-Ras (KRAS) mutation status in adults with metastatic colorectal cancer (mCRC). The committee backed use of therascreen KRAS RGQ PCR Kit from Qiagen and KRAS LightMix Kit from Tib Molbiol. Both tests have CE Mark approval.

The committee also recommended laboratory-developed tests (LDTs) using pyrosequencing of codons 12, 13 and 61 and matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometry of codons 12, 13 and 61. NICE said there was insufficient evidence to make recommendations and requested additional data for 5 other tests, including Qiagen's therascreen KRAS Pyro Kit, KRAS StripAssay from ViennaLab and cobas KRAS Mutation Test from Roche. The committee also said there was insufficient evidence for LDTs using high-resolution melt analysis of codons 12, 13 and 61 and next-generation sequencing of codons 12, 13 and 61. Comments on the draft guidance are due Oct. 24. ...