The US Food and Drug Administration has approved Roche’s diagnostic test for KRAS mutations to help physicians select the most effective treatment pathway for patients with advanced colorectal cancer.
The cobas KRAS Mutation Test is a polymerase chain reaction-based diagnostic test intended to detect mutations in codons 12 and 13 of the KRAS gene. The test can be performed in less than eight hours, enabling doctors to make treatment decisions quickly and confidently.
The purpose of the test is to identify those patients who do not carry KRAS mutations and therefore stand to benefit from treatment with Lilly’s Erbitux (cetuximab) or Amgen’s Vectibix (panitumumab).
“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 Swiss drug giant noted.