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."
Source: Ventana Medical Systems, Inc.