bioMérieux'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

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 MekinistTM (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 bioMérieux 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. vThe THxID®-BRAF test is a companion diagnostic assay developed by bioMérieux, 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.¹

“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 bioMérieux 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 bioMérieux’s global R&D team at the Christophe Mérieux 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, bioMérieux. “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.”

About Melanoma and Metastatic Melanoma

Melanoma is the most serious and deadly form of skin cancer.² According to statistics from the American Cancer Society, in 2012, there were an estimated 76,250 new cases of melanoma and an estimated 9,180 deaths in the United States.³ When melanoma spreads in the body, the disease is called metastatic melanoma.⁴ According to the National Cancer Institute’s Surveillance, Epidemiology and End Results, approximately four percent of melanomas have metastasized to distant locations in the body at the time of diagnosis.⁵ Nearly half of all people with metastatic melanoma have a BRAF mutation, which is an abnormal change in a gene that can enable some melanoma tumors to grow and spread.

About THxID® BRAF

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 Applied BioSystems 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 bioMérieux

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 41 subsidiaries and a large network of distributors. In 2013, revenues reached €1.588 billion with 87% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479). Corporate website: www.biomerieux.com

About Clarient Diagnostic Services, Inc.

Clarient is a CLIA licensed facility that combines innovative diagnostic technologies with world class pathology expertise to assess and characterize cancer. Clarient's mission is to become the leader in cancer diagnostics by dedicating itself to collaborative relationships with the healthcare community to translate cancer discovery and research into better patient care. Clarient was acquired by GE Healthcare in December of 2010. For more information, visit www.clarientinc.com.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For our latest news, please visit http://newsroom.gehealthcare.com

Media Contacts

GE Healthcare
Scott Lerman
(609) 514-6346 (office)
(609) 937-9253 (mobile)
scott.lerman@ge.com

bioMérieux
Allan MOhess
(919) 620-2937 (office)
(202) 415-7167 (mobile)
Allan.mohess@biomerieux.com

Baker & Yorke
Erik Yorke
(216) 339-9494
eyorke@baker-yorke.com

¹ Flaherty KT, Robert C, Hersey P, et al. Improved Survival with MEK Inhibition in BRAF-Mutated Melanoma. NEJM. 2012;367:107-14.
² Skin Cancer Foundation. “What Is Melanoma?” May 2013. Available at: http://www.skincancer.org/skin-cancer-information/melanoma.
³ American Cancer Society. “Cancer Facts & Figures 2012.” Available at http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/docume.... Page 4, Table 1, “Melanoma-Skin” Line.
⁴ Melanoma Research Foundation. “Staging Melanoma.” Available at http://www.melanoma.org/learn-more/melanoma-101/staging-melanoma. Page 1, Table 1, “Melanoma Stage IV” Line.
⁵ Surveillance Epidemiology and End Results. State Fact Sheets: Melanoma of the Skin. Available at: http://seer.cancer.gov/statfacts/html/melan.html#survival. Page 2, “Survival & Stage” section, Table 1, “Distant (cancer has metastasized)” Line.