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Ventana signs exclusive licensing agreement for the commercialization of a novel BRAF V600E mutation antibody for cancer detection

May 31, 2012

TUCSON, Ariz., May 31, 2012 /PRNewswire/ — Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, has signed an exclusive license agreement with the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) and University Hospital Heidelberg, Germany to commercialize a novel immunohistochemistry (IHC) primary antibody developed by researchers Andreas von Deimling, MD, Hanswalter Zentgraf, PhD and David Capper, MD, to detect the V600E BRAF mutation protein. This new IHC diagnostic from Ventana will add to the already robust Roche portfolio of BRAF diagnostics.

The BRAF protein plays a role in regulating cell signaling, and it has been shown to be mutated in many human cancers. The VENTANA antibody is being developed both as an in vitro diagnostic (IVD) and for research use only (RUO). These products are expected to be the first validated, commercially-available IHC antibodies capable of specifically detecting BRAF mutations. Today, cancer researchers are evaluating applications of V600E mutation testing in the diagnosis, prognosis, and prediction of patient response to therapy in major cancers including colorectal, thyroid, brain, and non-Hodgkin lymphoma.

“Ventana is collaborating with leading cancer researchers like Paul Waring, MD, PhD at the University of Melbourne to study BRAF V600E to improve the stratification of colon cancers,” says Tom Grogan, MD, Ventana Founder and SVP, Medical Affairs. “Specifically, we are investigating the significance of BRAF V600E mutations in the prognosis and prediction of therapy response for patients with this type of cancer.”

Andreas von Deimling, MD, Director of Neuropathology at the University Heidelberg and of DKFZ`s Clinical Cooperation Unit Neuropathology, says, “We are glad to find our mutation specific antibodies in the center of interest of so many clinicians and hope that this development will assist in improving diagnosis and directing therapy for cancer patients.”

Greg Yap, Lifecycle Leader for Advanced Staining Assays at Ventana adds, “Traditional IHC is not intended to differentiate between mutant and normal protein. Roche, Ventana, and Spring Bioscience are leading the diagnostics industry in pioneering novel, next generation antibodies that can differentiate mutant and normal protein to enable pathologists to see clinically-relevant mutations within their cellular context. By applying advanced antibody technology on our market-leading BenchMark automated platforms worldwide, we can deliver novel cancer diagnostic tests for significant global unmet medical needs.”

Ventana subsidiary Spring Bioscience will commercialize a BRAF V600E RUO antibody to support research applications. This product will be commercially available May 31, 2012 through Spring Bioscience (www.springbio.com) and some of its distributors.

Ventana is currently developing the V600E BRAF mutation-specific antibody for IVD use to detect V600E BRAF mutation protein on its VENTANA BenchMark series of automated instruments utilized by thousands of anatomic pathology labs worldwide.

“I am very pleased to announce this exclusive licensing agreement with University Hospital Heidelberg to produce what we expect to be the first validated, commercially-available IHC antibodies capable of specifically detecting BRAF mutations to help support cancer diagnosis and inform treatment decisions,” says Mara G. Aspinall, President of Ventana Medical Systems, Inc. It is another example of our ongoing commitment to improving patients’ lives with the most advanced diagnostic solutions available globally.”

About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. (“VMSI”) (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA solutions are used in clinical histology and drug development research laboratories worldwide. The company’s intuitive, integrated staining, workflow management platforms, and digital pathology solutions optimize laboratory efficiencies to reduce errors, support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI is driving Personalized Healthcare through accelerated drug discovery and the development of “companion diagnostics” to identify the patients most likely to respond favorably to specific therapies. Visit www.ventana.com to learn more.

VENTANA, the VENTANA logo, and BenchMark are trademarks of Roche.

About Deutsches Krebsforschungszentrum, DKFZ:
The German Cancer Research Center (DKFZ) with its more than 2,500 employees is the largest biomedical research institute in Germany. At DKFZ, more than 1,000 scientists investigate how cancer develops, identify cancer risk factors and endeavor to find new strategies to prevent people from getting cancer. They develop novel approaches to make tumor diagnosis more precise and treatment of cancer patients more successful. Jointly with Heidelberg University Hospital, DKFZ has established the National Center for Tumor Diseases (NCT) Heidelberg where promising approaches from cancer research are translated into the clinic. The staff of the Cancer Information Service (KID) offers information about the widespread disease of cancer for patients, their families, and the general public. The center is a member of the Helmholtz Association of National Research Centers. Ninety percent of its funding comes from the German Federal Ministry of Education and Research and the remaining ten percent from the State of Baden-Wurttemberg.

About Heidelberg University Hospital:
Heidelberg University Hospital and the Medical Faculty of Heidelberg University Patient Care, Research and Teaching of International Standard Heidelberg University Hospital is among the largest and most renowned medical centers in Germany. The Medical Faculty of Heidelberg University ranges among the internationally relevant biomedical research institutes in Europe. The common goal is to develop new therapies and to apply them rapidly for the benefit of the patient. The Hospital and the Faculty have approximately 11,000 employees and are active in training and qualification. In more than 50 departments, clinics and special departments with about 2,000 hospital beds, approximately 600,000 patients receive inpatient and outpatient treatment each year. There are currently about 3,600 aspiring doctors studying medicine in Heidelberg; the Heidelberg Curriculum Medicinale (HeiCuMed) is at the top of medical teaching and training in Germany.

SOURCE Ventana Medical Systems, Inc.


Source: PR Newswire