FDA Clears Roche’s KRAS Mutation Test for Colorectal Cancer Patients

Today, Roche announced that US health regulators have approved its diagnostic test for a certain gene mutation in patients with advanced colorectal cancer.

The company said that the US Food and Drug Administration (FDA) approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer (mCRC), in order to assist clinicians in determining an appropriate therapeutic path.

The cobas KRAS Mutation Test is a TaqMelt assay, a PCR-based diagnostic test intended for detection of mutations in codons 12 and 13 of the KRAS gene. The test can be performed in less than eight hours, allowing physicians to make confident treatment decisions in a timely manner.

There has been an increased interest in precision medicine and tailoring treatment based on a patient’s genetic makeup. While the effort has gained recent traction in several therapeutic areas, oncology researchers have been working on personalizing therapy for cancer patients for the last ten years. Now that there are several targeted drugs available for cancer patients, tools to identify which patients will benefit most from these drugs are needed.

“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.”

Colorectal cancer is the second leading cause of cancer-related deaths in the US and the third most common cancer in men and women, according to the Centers for Disease Control and Prevention (CDC). The diagnostic test will help physicians identify mCRC patients for whom treatment with Lilly’s Erbitux (cetuximab) or Amgen’s Vectibix (panitumumab) may be effective if no KRAS mutation is present.

Source: Roche

Last updated: 5/11/15; 11:45am EST

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