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FDA Approves Roche Cobas EGFR Mutation Test as CDx for Iressa

NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has approved its Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZeneca's cancer drug Iressa (gefitinib) for first-line treatment of patients with non-small cell lung cancer.

The approval includes the use of either tumor tissue or plasma. It follows previous approvals of the test as a CDx with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).

The Cobas EGFR Mutation Test v2 is a real-time PCR test that detects 42 mutations in the EGFR gene in exons 18 to 21, including L858R, exon 19 deletions, and T790M mutations. It runs on Roche's Cobas 4800 system. Roche pointed out that the test is currently the only FDA-approved diagnostic for NSCLC that can use both tissue and liquid biopsy patient samples.