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First Blood-Based Lung Cancer EGFR Test Gets Green Light

This article was originally published in Clinica

Executive Summary

FDA has approved Roche Diagnostic’s cobas EGFR Mutation Test v2 as a companion diagnostic to Tarceva (erlotinib), a Roche/Astellas Pharma 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.

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