KRAS Mutation Test for Colorectal Cancer Diagnosis Approved

A real-time polymerase chain reaction test has been designed to identify the Kirsten rat sarcoma viral oncogene (KRAS) mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.

According to the US Centers for Disease Control and Prevention (Atlanta, GA, USA) colorectal cancer is the second leading cause of cancer-related deaths in the United States and the third most common cancer in men and women and several germline mutations are predictive of poor response to therapy.


The cobas KRAS Mutation Test (Roche, Basel Switzerland) is intended to be used as an aid in the identification of mCRC patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective if no KRAS mutation is present. The cobas KRAS Mutation Test is a TaqMelt assay; 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 US Food and Drug Administration (FDA; Silver Springs, MD, USA) have approved the cobas KRAS Mutation Test for diagnostic use. The test is performed on the Roche 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 USA includes the cobas KRAS Mutation Test, the cobas BRAF V600 Mutation Test and the cobas EGFR Mutation Test.

Paul Brown, PhD, 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 the USA including tests for BRAF (melanoma) EGFR (lung cancer) and KRAS (mCRC) mutations.”

Related Links:
US Centers for Disease Control and Prevention
Roche 
US Food and Drug Administration