Quest Diagnostics Introduces bioMerieux THxID®-BRAF Companion Diagnostic to Advance Precision Medicine for Melanoma

Source: Market Watch<.June 2014

MADISON, N.J., June 10, 2014 /PRNewswire/ — Quest Diagnostics , the world’s leading provider of diagnostic information services, today introduced a new cancer test service based on the FDA-approved THxID®-BRAF test from bioMerieux, a world leader in the field of in vitro diagnostics. The THxID®-BRAF test is a companion diagnostic for two treatments for melanoma. The test is intended to be used as an aid in selecting patients with melanoma whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].

The U.S. Food and Drug Administration approved the two drugs and the gene test as a companion diagnostic in May 2013. The drugs, manufactured by GlaxoSmithKline, treat patients with advanced (metastatic) or unresectable (cannot be surgically removed) melanoma, the most dangerous type of skin cancer. bioMerieux manufactures the THxID-BRAF test kit.

Beginning today, dermatologists, oncologists, hospital pathologists and other physicians may order the test through Quest Diagnostics, including its AmeriPath and Dermpath businesses, which specialize in anatomic and dermatologic pathology testing.

“Because of this relationship with Quest, many more doctors will have access to THxID®-BRAF test. This means that more patients with advance melanoma will benefit from the optimized treatment that results when the THxID®-BRAF test is used in designing their regimens," said Dr. Samuel Bozzette, Vice President, Medical Affairs – Americas, bioMerieux, Inc.

“The addition of the THxID-BRAF test to our menu reflects our commitment to offering the most advanced dermatopathology testing available and to the field of precision medicine, which aims to improve outcomes based on a holistic clinical understanding of the patient," said Frederic Waldman MD, PhD, medical director, cancer diagnostics, Quest Diagnostics. “The THxID-BRAF test further extends the services we provide for melanoma and other cancers across a continuum of care, giving physicians insights to help guide treatment decisions and empower better health."

“Because Quest reaches about half of the practicing physicians and hospitals in the United States, patients and providers will now have access to the THxID-BRAF test on a truly broad national scale," added Dr. Waldman.

In addition to the bioMerieux test, Quest offers the FDA-cleared cobas® 4800 BRAF V600 Mutation Test, which detects the BRAF V600E mutation in order to help physicians select patients for treatment with vemurafenib, an oral medicine designed to treat patients whose melanoma tumors harbor the mutation. Quest also offers a laboratory-developed test for assessing BRAF mutations in melanoma, thyroid, and colorectal cancers based on sanger sequencing.

BRAF is a gene implicated in several cancers, including melanoma. Approximately half of melanomas arising in the skin have a BRAF gene mutation.

Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimates 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease in 2014.

About the bioMerieux THxID®-BRAF test The THxID ® -BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The THxID ® -BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].

About Quest Diagnostics Quest Diagnostics is the world’s leading provider of diagnostic information services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

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