Cobas KRAS Mutation Test Receives FDA Approval

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Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid clinicians in determining a therapeutic path for them.

The new assay is intended to be used as an aid in the identification of patients with metastatic colorectal cancer for whom treatment with cetuximab (Erbitux) or panitumumab (Vectibix) may be effective if no KRAS mutation is present.

The cobas KRAS Mutation Test is a TaqMelt assay, a PCR-based diagnostic test intended for the detection of mutations in codons 12 and 13 of the KRAS gene. The test, which is performed on the cobas 4800 System, can be conducted in less than 8 hours. ■





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