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Roche Liquid Biopsy Test First to Garner FDA Approval

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.

The test was originally approved in 2013 for use on DNA derived from formalin-fixed, paraffin-embedded tumor tissue from NSCLC patients, and was the first companion diagnostic gauging EGFR mutations to receive a nod from the FDA.

Liquid biopsies "have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a statement.

Following a negative result, the agency advises doctors perform a tumor biopsy. But a positive liquid biopsy test could be beneficial to a patient who may be too ill or otherwise unable to provide a tumor specimen.