CBLPath Offers Only FDA-Approved BRAF Companion Diagnostic In-House After Approval from New York State Department of Health
Published: Feb 17, 2012
RYE BROOK, NY--(Marketwire - February 16, 2012) - CBLPath announces today that it received approval from the New York State Department of Health to perform in-house the cobas® 4800 BRAF V600 Mutation Test for metastatic melanoma. The laboratory is one of a few in the U.S. that is offering the test.
The BRAF V600 companion diagnostic is the sole test approved by the U.S. Food and Drug Administration (FDA) for Zelboraf® (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.
To speak with a CBLPath representative about ordering the BRAF V600 test, call 877.225.7284. To see the company's entire array of tests, visit www.CBLPath.com and click Test Menu.
For more information about the FDA's approval of Zelboraf and the BRAF V600 companion diagnostic, visit the News & Events section at www.fda.gov.
CBLPath is a national specialty lab with a unique leadership position in the convergence of anatomic, molecular and digital pathology. Beginning from a clinical perspective, we harness molecular testing and digital pathology on an anatomic pathology foundation. CBLPath is committed to helping our clients deliver better medicine, faster. At our core are pathologists; excited about technology and innovation and its promise of helping patients. Through the Best Practice™ Partnership Program we help our pathologist-clients effectively compete against centralized reference laboratories, grow their Practice and remain independent -- Keeping Medicine Local™. We provide our subspecialty physician clients comprehensive diagnostics and timely, accurate reports enabling the best patient care. For more about the company, please visit www.CBLPath.com.
Nicole A. York