Switzerland-based biotech company Roche has received a US Food and Drug Administration (FDA) approval for the use of its cobas KRAS Mutation Test for diagnosis.
The cobas test is a TaqMelt assay, a polymerase chain reaction (PCR) based diagnostic test used to detect mutations in codons 12 and 13 of the KRAS gene.
The test can help physicians make speedy treatment decisions as it can be performed in less than eight hours.
Performed on the cobas 4800 System, the test offers high-performance amplification and detection along with software that can provide automated results interpretation and reporting.
The real-time PCR test can help identify KRAS mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and help clinicians to decide on a therapeutic solution for them.
The cobas KRAS Mutation Test will be used for the identification of mCRC patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) might be useful in case no KRAS mutation is present.
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."
Colorectal cancer is said to be the second leading cause of cancer-related deaths in the US and the third most common cancer in men and women, according to the Centers for Disease Control and Prevention.