Firm will make RUO test available immediately and will further develop an IVD.
Ventana Medical Systems signed an exclusive license agreement with the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) and University Hospital Heidelberg to commercialize an immunohistochemistry (IHC) primary antibody to detect the V600E BRAF mutation protein in cancer. It is being developed both as an in vitro diagnostic (IVD) and for research use only (RUO).
Ventana subsidiary Spring Bioscience will commercialize the BRAF V600E RUO antibody to support research applications starting today. Ventana is developing the V600E BRAF mutation-specific antibody for IVD use on its Ventana BenchMark series of automated instruments.
“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.
Last February Amoy Diagnostics obtained CE Mark approval for its BRAF mutation detection kits, which were previously sanctioned in China. It detects the mutation that causes the V600E amino acid substitution in the BRAF protein.
The IHC antibody was developed by researchers Andreas von Deimling, M.D., Hanswalter Zentgraf, Ph.D., and David Capper, M.D. The BRAF protein plays a role in regulating cell signaling and has been shown to be mutated in many human cancers. Cancer researchers are already evaluating applications of V600E mutation testing in the diagnosis, prognosis, and prediction of patient response to therapy in cancers including colorectal, thyroid, brain, and non-Hodgkin lymphoma.
“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,” says Dr. von Deimling, director of neuropathology at the University Heidelberg and of DKFZ`s clinical cooperation unit neuropathology.
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.”
Tom Grogan, M.D., Ventana founder and svp, medical affairs, says, “Ventana is collaborating with leading cancer researchers like Paul Waring, M.D., Ph.D., at the University of Melbourne to study BRAF V600E to improve the stratification of colon cancers. 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.”
Roche’s approved melanoma treatment Zelboraf is an orally administered BRAF inhibitor. FDA approved the drug last August for late-stage or unresectable BRAF V600E melanoma. The company is studying Zelboraf as a treatment for papillary thyroid cancer (Phase II) as well as in combination with Bristol-Myers Squib’s approved melanoma drug, Yervoy, in patients with tumors expressing a BRAF V600E (Phase I/II).