The FDA has approved Roche's cobas EGFR Mutation Test as a companion diagnostic for Tarceva, or erlotinib, a nonsmall-cell lung cancer drug developed by Roche's Genentech unit. The test, designed to determine which patients will benefit from Tarceva, is the first FDA-approved companion diagnostic that can detect epidermal growth factor receptor mutations found in around 10% of nonsmall-cell lung cancer.

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