CBLPath Offers Only FDA-Approved BRAF Companion Diagnostic In-House After Approval From New York State Department of Health
Test Determines Which Melanoma Patients Are Candidates for Zelboraf(R)
The BRAF V600 companion diagnostic is the sole test approved by the U.S. Food and Drug Administration (FDA) for Zelboraf(R) (vemurafenib), and aids physicians in making the best treatment decisions for patients with inoperable or metastatic melanoma who may be candidates for the drug.
The test detects the BRAF V600E mutation in the BRAF proto-oncogene from human melanoma tumor specimens, which is necessary to identify patients who are eligible for Zelboraf treatment. About half of all melanoma patients test positive for the BRAF mutation. BRAF V600 has shown improved sensitivity and accuracy when compared to other commonly used, unapproved detection methods.
"The approval by the State of New York provides CBLPath with a state-of-the-art diagnostic tool designed to deliver more timely, expert medical care to melanoma patients not only in New York, but also across the country," said Chief Medical Officer Carlos D. Urmacher, M.D., FCAP, FASCP. "It's another step in CBLPath's commitment to remain at the forefront of personalized medicine tailoring healthcare practices to individual patients. By offering tests such as this, we truly help to make a qualitative difference in patients' lives."
Melanoma is the deadliest and most aggressive form of skin cancer. Only modest response rates are typically seen with treatment options available for patients with advanced melanoma. Zelboraf provides a new and more effective treatment for late-stage melanoma, and works by inhibiting the mutated form of BRAF protein. It is the first and only FDA-approved targeted therapy shown to improve survival in patients with BRAF V600E mutation-positive metastatic melanoma.
FDA approval was given to Roche Molecular Systems for the new cobas 4800 BRAF V600 Mutation Test and concurrently to Genentech, a member of the Roche Group, for Zelboraf. CBLPath is offering the test through its affiliation with Roche Diagnostics.
Category: Pathology News