Roche has submitted the cobas EGFR Mutation Test v2 for premarket approval to the US Food and Drug Administration (FDA) as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients (NSCLC) with an acquired resistant mutation.

AZD9291 is a once daily, selective, irreversible EGFR TKI designed to target both the activating sensitizing mutation, EGFRm, and T790M, the genetic mutation responsible for EGFR TKI treatment resistance in up to approximately two-thirds of cases of EGFRm advanced NSCLC. AZD9291 has been granted breakthrough therapy designation, orphan drug and fast track status by the FDA. The cobas EGFR Mutation Test v2 is built upon the existing FDA-approved cobas EGFR Mutation Test, developed by Roche. It is intended to identify a broad spectrum of EGFR mutations for patients with NSCLC, including the T790M acquired resistant mutation.

Source: Roche