FDA has granted premarket approval (PMA) for diagnostic use of the Cobas KRAS mutation test by Roche Molecular Systems Inc, Pleasanton, Calif. The real-time polymerase chain reaction (PCR)-based test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.

“As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes critical,” says Paul Brown, head of Roche Molecular Diagnostics. “The Cobas KRAS mutation test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient.”

The Cobas KRAS mutation test is a TaqMelt assay—a 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 8 hours, so physicians can make treatment decisions quickly and confidently.

FDA’s approval adds to Roche’s portfolio of oncology companion diagnostics approved by the agency for use in the United States, which includes tests for BRAF (melanoma) and EGFR (lung cancer) mutations. All three tests are performed on the Cobas 4800 system, which offers high-performance amplification and detection coupled with software that automates results interpretation and reporting.

According to the Centers for Disease Control and Prevention, 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.

The Cobas KRAS mutation test 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.

For further information, visit Roche Molecular Diagnostics.