FDA approves cobas EGFR Mutation Test v2 companion diagnostic for Tagrisso (osimertinib) for T790M mutated metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer- AstraZeneca

AstraZeneca announced that the FDA has approved a blood-based companion diagnostic for Tagrisso (osimertinib). The cobas EGFR Mutation Test v2 companion diagnostic for Tagrisso is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after an EGFR tyrosine kinase inhibitor (TKI) medicine.

The approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive NSCLC, ensuring that those patients who may not be suitable for biopsy procedures have an opportunity to be tested. Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained. Patients who test negative for the T790M mutation with the blood-based test, and their physicians, should re-evaluate the feasibility of tissue-based testing to confirm the presence of the EGFR T790M mutation.

Comment: The companion diagnostic, cobas EGFR Mutation Test v2, was developed by Roche Molecular Systems. The test enables identification of patients who have the T790M mutation at disease progression, and is initially available through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America Holdings (LabCorp), and PhenoPath.