Roche Wins FDA Approval for Colon Cancer Diagnostic

Roche’s cobas KRAS mutation test has won FDA approval, the Swiss-based devicemaker announced Monday. The diagnostic is intended for metastatic colorectal cancer patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective if no KRAS mutation is found.

The test uses a polymerase chain reaction-based, TaqMelt assay to detect mutations in KRAS gene codons 12 and 13, and is meant to be performed using the cobas 4800 system. The diagnostic takes less than eight hours, the company says.

Roche also offers FDA-approved tests for melanoma and lung cancer.

Colorectal cancer is the second-leading cause of U.S. cancer-related deaths, says the CDC. — Jason Scott