The US Food and Drug Administration (FDA) has approved Roche's cobas KRAS mutation test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumour samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.
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 US, including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations. The cobas KRAS mutation test is intended to be used as an aid in the identification of mCRC patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective if no KRAS mutation is present.
The test is performed on the cobas 4800 System, which provide high-performance amplification and detection coupled with software that automates results interpretation and reporting. The cobas 4800 System menu for oncology in the U.S. includes the cobas KRAS mutation test, the cobas BRAF V600 mutation test and the cobas EGFR mutation test. The cobas KRAS Mutation Test is a TaqMelt assay; a polymerase chain reaction (PCR)-based diagnostic test intended for the detection of mutations in codons 12 and 13 of the KRAS gene. The test can be performed in less than eight hours, so physicians can make treatment decisions quickly and confidently.
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