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First Blood-Based Lung Cancer EGFR Test Gets Green Light

FDA has approved the first liquid biopsy test to detect genetic mutations linked to drug response in patients with non-small cell lung cancer. Roche's cobas EGFR Mutation Test v2 could be a game-changer in helping to diagnose certain NSCLC patients without requiring a tumor biopsy, the agency suggests.

FDA has approved Roche Diagnostics Corp.'s cobas EGFR Mutation Test v2 as a companion diagnostic to Tarceva (erlotinib), a Roche/Astellas Pharma Inc. drug to treat non-small cell lung cancer (NSCLC). The test is the first blood-based genetic test approved by FDA to detect epidermal growth factor receptors genetic mutations that are associated with treatment response to Tarceva.

Roche first gained approval for a companion diagnostic to Tarceva in 2013, but that was for evaluating tumor biopsy rather than blood samples. (See Also see "New Products In...

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