Cobas EGFR Mutation Test v2 companion diagnostic for NSCLC filed with FDA- Roche

Roche has submitted the Cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the FDA, as a companion diagnostic test for AZD 9291, an Astra Zeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation.

Patients with non-small cell lung cancer who have adenocarcinoma containing an EGFR sensitizing mutation show significant benefit from currently available EGFR tissue kinase inhibitor therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired T790M mutation. The Cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.

This new version 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 non-small cell lung cancer, including the T790M acquired resistance mutation.