FDA Approves Roche’s Companion Diagnostic Test for Melanoma Mutation

Roche has announced that the U.S. Food and Drug Administration (FDA), has approved the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. The FDA has also just approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma.

When diagnosed early, melanoma is often curable. Once it has spread to other parts of the body however, it is the deadliest and most aggressive form of skin cancer. Once diagnosed with metastatic melanoma, a patient’s prognosis is poor and life expectancy is typically measured in months not years.

The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state may cause excessive signalling in the pathway, and lead to uncontrolled cell growth and survival. Such BRAF mutations are thought to occur in approximately half of all melanomas.

The cobas 4800 BRAF V600 Mutation Test is a polymerase chain reaction-based diagnostic test developed by Roche. The test shows greater sensitivity and reliability for detecting mutations than Sanger sequencing, and produces quicker results. Clinicians will then be able to determine whether the patient is eligible for treatment with Zelboraf, which has been shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma.

“The cobas BRAF Mutation Test has improved sensitivity, accuracy and speed compared to other commonly used, unapproved detection methods,” said Paul Brown, head of Roche Molecular Systems. “With a personalized medicine now available, all people diagnosed with inoperable or metastatic melanoma should be tested to help determine the best options for treatment.”