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Roche EGFR Mutation Test Approved by FDA as Companion Diagnostic for NSCLC

NEW YORK – Roche announced Thursday its Cobas EGFR Mutation Test v2 received approval from the US Food and Drug Administration of expanded claims as a companion diagnostic for non-small cell lung cancer therapies.

The test can be used as a companion diagnostic for all five FDA-approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor therapies targeting EGFR mutations L858R and Exon 19 deletions, Roche said in a statement. The five therapies Roche's test can be used with are afatinib (Boehringer Ingelheim's Gilotrif), gefitinib (AstraZeneca's Iressa), dacomitinib (Pfizer's Vizimpro), erlotinib (Genentech's Tarceva), and osimertinib (AstraZeneca's Tagrisso).

The test can also be used as a companion diagnostic for any future approved EGFR TKI therapies targeting the same mutations without having to conduct individual clinical studies for each therapy.

Roche's real-time PCR test detects defined mutations of the EGFR gene in NSCLC patients from DNA isolated from formalin-fixed paraffin-embedded tumor tissue or circulating tumor DNA from plasma from whole blood. Results are available in less than eight hours, the company said. 

This approval is the first group companion diagnostic labeling under recent guidance from the FDA to help diagnostic companies determine if their tests could be used to support a broader label claim, like use with a specific group of oncology therapeutic products instead of just one therapeutic.