Roche Seeks to Link Mutation Test With AZ Cancer Treatment

July 31, 2015

Roche is seeking premarket approval from the FDA for its cobas EGFR Mutation Test v2 to be used a companion diagnostic test with AstraZeneca’s investigational therapy for non-small cell lung cancer patients with an acquired resistance mutation.

Roche says its test can aid clinicians appropriately select cancer patients who have acquired a certain mutation who are most likely to benefit from AZ’s therapy.

Roche’s new test is built upon an existing FDA-approved test developed by the company and is intended to identify a broad spectrum of mutations in lung cancer patients including the mutation targeted in the AZ treatment.

Headquartered in Basel, Switzerland, Roche employs about 88,500 people worldwide. — John Bechtel