Roche Receives FDA Approval for cobas® KRAS Mutation Test

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the cobas® KRAS Mutation Test for diagnostic use. The real-time PCR 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,” said 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. With this approval, Roche now offers the most comprehensive companion diagnostic FDA approved portfolio for oncology in the U.S., including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations.”

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.

About the cobas® KRAS Mutation Test and the cobas® 4800 System:

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 test is performed on the 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 U.S. includes the cobas® KRAS Mutation Test, the cobas® BRAF V600 Mutation Test and the cobas® EGFR Mutation Test.