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First Blood-Based Lung Cancer EGFR Test Gets FDA Green Light

Roche's cobas EGFR Mutation Test v2 liquid biopsy test is approved to detect genetic mutations linked to drug response in patients with non-small cell lung cancer treated with Tarceva.

FDA has approved Roche Diagnostics Corp.'s cobas EGFR Mutation Test v2 as a companion diagnostic to Tarceva (erlotinib), the Roche/Astellas Pharma Inc. drug to treat non-small cell lung cancer. The test is the first blood-based genetic test approved by FDA to detect epidermal growth factor receptors genetic mutations, specifically those 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 Also see "New Products In Brief"...

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