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FDA approves cobas KRAS Mutation Test for metastatic colorectal cancer
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Roche today announced that it was granted FDA approval for the cobas KRAS Mutation Test, a diagnostic test used to help determine appropriate therapy options for patients with metastatic colorectal cancer, according to a press release.
The cobas KRAS Mutation Test (Roche) is a real-time polymerase chain reaction test designed to detect mutations in codons 12 and 13 of the KRAS gene in tumor samples from patients with metastatic colorectal cancer. The test is intended to help identify patients with wild-type KRAS for whom cetuximab (Erbitux, ImClone) or panitumumab (Vectibix, Amgen) may be effective.
The test can be performed in less than 8 hours, allowing clinicians to make informed treatment decisions quickly, according to the press release.
"As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes critical," Paul Brown, Head of Roche Molecular Diagnostics, said in a press release. "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 (metastatic colorectal cancer) mutations."