LONDON (dpa-AFX) - AstraZeneca (AZN.L) announced the US FDA has approved a blood-based companion diagnostic for TAGRISSO. The companion diagnostic, cobas EGFR Mutation Test v2, was developed by Roche Molecular Systems. The company said 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.
The test is initially available through Baystate Health, Carolinas HealthCare System, LabCorp, and PhenoPath.
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