Roche Liquid Biopsy Test First to Garner FDA Approval | GenomeWeb

NEW YORK (GenomeWeb) – The US Food and Drug Administration today announced it has approved Roche's blood-based cobas EGFR Mutation Test v2 to detect EGFR mutations associated with non-small cell lung cancers.

This is the first blood-based genetic test for NSCLC-related mutations approved by the agency. It can now be used as a companion diagnostic for Genentech's cancer drug Tarceva (erlotinib). Specifically, the detection of exon 19 deletion or exon 21 (L858R) substitution mutations in blood samples aids in selecting patients who may benefit from treatment with the drug.

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