AstraZeneca announced that the  Food and Drug Administration (FDA) has approved cobas EGFR Mutation Test v2, a companion diagnostic for Tagrisso (osimertinib).

The companion diagnostic test uses either a blood or tissue 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 test provides a non-invasive alternative for patients who may not be suitable for biopsy procedures. A blood-based test for the presence of a T790M mutation is recommended only when a tumor biopsy cannot be obtained. 

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Blood-based testing for T790M has been conducted in multiple studies, including the Phase I/II AURA trials, a cross-platform comparison of technologies that supported the development of Tagrisso. “Blood-based testing has the potential to rapidly identify patients eligible for targeted therapy, who may not be eligible for biopsy,” said Balazs Halmos, MD, Albert Einstein College of Medicine.

Most cases of progression with first-generation EGFR TKIs are related to an acquired EGFR T790M mutation. Tagrisso is the only FDA-approved targeted medicine for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after an EGFR TKI medicine.

The diagnostic cobas EGFR Mutation Test v2 was developed by Roche Molecular Systems. It is initially available through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America Holdings (LabCorp), and PhenoPath.

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