Roche submits cobas EGFR v2 test PMA to FDA as companion diagnostic test for AZD9291

Roche today announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the U.S. Food and Drug Administration, as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.