The US Food and Drug Administration (FDA) has approved Roche's cobas KRAS Mutation Test for diagnostic application.
The cobas KRAS is a polymerase chain reaction (PCR) based diagnostic test designed to detect mutations in KRAS codons 12, 13 and 61 to identify colorectal cancer patients who are not likely to respond to anti-epidermal growth factor receptor monoclonal antibody therapies.
Performed in less than eight hours, the TaqMelt assay is planned to be used as an aid in the identification of metastatic colorectal cancer (mCRC) patients for whom treatment with Erbitux or Vectibix may be effective, in the absence of KRAS mutation.
Roche Molecular Diagnostics head Paul Brown said: "As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes critical.
"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 test is performed on the cobas 4800 System, which provides high-performance amplification and detection coupled with software that automates interpretation and reporting of results.
The cobas 4800 System menu for oncology in the US includes the cobas KRAS Mutation Test, the cobas BRAF V600 Mutation Test, as well as the cobas EGFR Mutation Test.
According to Centers for Disease Control and Prevention, colorectal cancer is the second leading cause of cancer-related deaths in the US, and the third most common cancer in both males and females.