Skip to main content
Premium Trial:

Request an Annual Quote

FDA Approves Roche KRAS Mutation Test for Metastatic Colorectal Cancer Patients

NEW YORK (GenomeWeb) — The US Food and Drug Administration has approved Roche's real-time PCR cobas KRAS Mutation Test for diagnostic use, the company said today.

The test helps to identify metastatic colorectal cancer patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective because their tumors carry no KRAS mutations.

The cobas KRAS mutation test, which is a TaqMelt assay that runs on the cobas 4800 system, detects mutations in codons 12 and 13 of the KRAS gene and can be performed in less than eight hours.

It adds to two other oncology tests that Roche offers on the cobas 4800 in the US, the cobas BRAF V600 Mutation Test for melanoma and the cobas EGFR Mutation Test for lung cancer.