Roche Seeks to Link Mutation Test With AZ Cancer Treatment

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