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bioMerieux’s THxID-BRAF Test for Detection of 2 BRAF Mutations V600E and V600K in Late-Stage Metastatic Melanoma adopted by Clarient, a GE Healthcare Company

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bioMerieux, Inc. and Clarient, a GE Healthcare Company recently announced that bioMerieux’s molecular diagnostic test THxID®-BRAF has been added to the service offerings provided by Clarient. Clarient will use THxID® BRAF in order to aid oncologists in selecting metastatic melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s (GSK) Tafinlar® (dabrafenib) as well as in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist™ (trametinib).

As a leading U.S. oncology testing laboratory, Clarient uses innovative and leading diagnostics technologies combined with world-class pathology expertise to assess and characterize cancer in order to provide the most advanced oncology testing and diagnostic services for better patient care. With a customer base of more than 2,000 pathologists, oncologists, clinical laboratories and hospitals, Clarient has selected the bioMerieux THxID®-BRAF assay to offer its customers the only test able to simultaneously detect the two prevalent BRAF mutations, V600E and V600K, providing high medical value information to select treatment for metastatic melanoma patients.

The THxID®-BRAF test is a companion diagnostic assay developed by bioMerieux, intended as an aid to oncologists in selecting melanoma patients who could benefit from treatments for their tumors which carry the BRAF V600E and V600K mutations. This novel assay received PMA approval from the FDA (Food and Drug Administration) for commercialization in the United States on May 30th 2013.

Among those cancer patients with metastatic melanoma, approximately half have a BRAF mutation which is an abnormal change in a gene that can enable some melanoma tumors to grow and spread. THxID®-BRAF has been validated for the detection of both the BRAF V600E mutation, which accounts for approximately 85 percent of all BRAF V600 mutations in metastatic melanoma as well as detection of the V600K mutation, which represents approximately 10 percent of all BRAF V600 mutations in metastatic melanoma.

“We believe personalized medicine is the new direction in diagnosing and treating cancer and Clarient uses state-of-the-art diagnostic technologies like the THxID®-BRAF test from bioMerieux for the simultaneous detection of both BRAF V600E and V600K mutations in late stage metastatic melanoma tumor samples.

This unique test will bring clarity and precision to physicians to assist them in making better treatment decisions for their patients,” said Cynthia Collins, General Manager, Clarient. “Clarient’s comprehensive offering and fast turnaround time coupled with our experience permit us to provide a higher level of performance to aid patients with metastatic melanoma.”

THxID®-BRAF is a real-time PCR test that offers clinicians a standardized, reproducible and clinically validated method to patients with BRAF-mutant unresectable or metastatic melanoma that may be suitable for treatment. Readily integrated into the laboratory, the test provides fast and accurate results to enable confident medical decisions. This novel assay was developed by bioMerieux’s global R&D team at the Christophe Merieux Center for molecular diagnostics research in Grenoble, France.

“We are very pleased to partner with Clarient. Together, we aim to provide clinicians with key information to help them choose an appropriate treatment for their melanoma patients,” said Mark Miller, Chief Medical Officer, bioMerieux. “The creation and commercialization of this high medical value test and this partnership with a leading laboratory in oncology mark a significant step forward to help raise the standard of care for better patient outcomes.”

Source: PR Newswire