Roche gets thumbs-up for KRAS test
June 2015
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PLEASANTON, Calif.—Roche has received U.S. Food and Drug Administration (FDA) approval for its PCR-based cobas KRAS Mutation Test for diagnostic use. The test identifies KRAS mutations in tumor samples from patients with metastatic colorectal cancer (mCRC) to help guide therapeutic decisions; more specifically, it is also meant as an aid in identifying mCRC patients who might benefit from Erbitux or Vectibix treatment if no KRAS mutation is detected.
“The cobas KRAS Mutation Test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient. With this approval, Roche now offers the most comprehensive companion diagnostic FDA approved portfolio for oncology in the U.S., including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations,” said Paul Brown, head of Roche Molecular Diagnostics.

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