Switzerland-based biotech company Roche has announced that it has received the U.S. Food and Drug Administration (FDA) approval for cobas KRAS Mutation Test. It is 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.
The test is performed on the cobas 4800 System, which offers 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.
Commenting on the approval Paul Brown, Head of Roche Molecular Diagnostics 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 US, including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations, he added.