FDA Approves Roche’s KRAS Mutation Test
By Stephanie Murg, Managing Director, G2 Intelligence Roche’s portfolio of companion diagnostics now includes a test that can help clinicians to tailor treatment for patients with metastatic colorectal cancer. The U.S. Food and Drug Administration has approved the company’s Cobas KRAS Mutation Test for diagnostic use. The real-time PCR-based test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer patients. “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, in a statement announcing the approval. “The Cobas KRAS Mutation Test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient.” A TaqMelt assay, the test can detect mutations in codons 12 and 13 of the KRAS gene within eight hours. If no KRAS mutation is present, the patient may be a good candidate for treatment with Erbitux (cetuximab) or Vectibix (panitumumab). The test is performed on Roche’s Cobas 4800 system, which can also run the BRAF V600 Mutation Test and the Cobas EGFR Mutation Test, both of which have been approved by the FDA for diagnostic use.
By Stephanie Murg, Managing Director, G2 Intelligence
Roche’s portfolio of companion diagnostics now includes a test that can help clinicians to tailor treatment for patients with metastatic colorectal cancer. The U.S. Food and Drug Administration has approved the company’s Cobas KRAS Mutation Test for diagnostic use. The real-time PCR-based test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer patients.
“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, in a statement announcing the approval. “The Cobas KRAS Mutation Test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient.”
A TaqMelt assay, the test can detect mutations in codons 12 and 13 of the KRAS gene within eight hours. If no KRAS mutation is present, the patient may be a good candidate for treatment with Erbitux (cetuximab) or Vectibix (panitumumab). The test is performed on Roche’s Cobas 4800 system, which can also run the BRAF V600 Mutation Test and the Cobas EGFR Mutation Test, both of which have been approved by the FDA for diagnostic use.
