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Roche seeks FDA approval for cobas EGFR Mutation Test v2

Roche is seeking approval from the US Food and Drug Administration (FDA) for its cobas EGFR Mutation Test v2.

The company has submitted premarket approval (PMA) to the FDA for the test to be recognized as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer (NSCLC) patients with an acquired resistant mutation.

The cobas EGFR Mutation Test v2 has been designed based on the existing FDA-approved cobas EGFR Mutation Test, which was developed by Roche.

It is developed to identify a wide range of EGFR mutations for patients with NSCLC, including the T790M acquired resistant mutation.

Roche Molecular Diagnostics (RMD) head Paul Brown said: "The collaboration with AstraZeneca to be the companion diagnostic for their third generation EGFR drug therapy is a testament to the innovation and quality of Roche oncology assays and demonstrates the value of molecular testing in patients.

"At Roche Molecular Diagnostics, we have one of the broadest portfolios of FDA-approved tests for oncology that enable clinicians to make informed treatment decisions for their patients."

AZD9291 is a once daily, selective and irreversible EGFR TKI, which was developed to target both activating sensitising mutation EGFRm and T790M. It received breakthrough therapy, orphan drug and fast track status by the FDA.