Ventana Medical Systems, Inc., a member of the Roche Group and Biocare Medical, LLC (Biocare) have entered into a non-exclusive license agreement to allow Biocare access to certain patents and materials related to p63 diagnostics in the research and IVD field.

In parallel, Biocare and AsymmetRx Medical, Inc. (AsymmetRx) have settled their dispute as it relates to the p63 technology. As part of the settlement, Biocare has gained a worldwide license through Ventana to distribute p63 (4A4) mouse monoclonal primary antibody in both the research and IVD market and AsymmetRx has agreed to terminate all patent infringement litigation. AsymmetRx holds the exclusive, worldwide license under the Harvard Medical School patent filings for the use of the p63 antibody as an aid in the diagnosis of prostate and other cancers. Financial terms of the license and settlement were not disclosed.

"Our mission is to improve the lives of all patients afflicted with cancer," says Mara Aspinall, president, Ventana Medical Systems, Inc. "Through our licensing programme, we make the most advanced products in the industry available to those in need and help ensure the standardization of diagnostic results to benefit patients."

The p63 gene was discovered in the Harvard lab of Dr Frank McKeon and the p63 cancer diagnostic test was invented by a collaboration of labs at Harvard Medical School, Dana Farber Cancer Institute and the Brigham and Women's Hospital. p63 protein is highly expressed in prostate, breast, bladder, and lung tissue and the p63 (4A4) mouse monoclonal antibody has been extremely useful in the differentiation of benign and malignant lesions in conjunction with morphological findings. Numerous articles in top clinical journals have cited the accuracy and utility of p63 as an aid in prostate cancer diagnosis, and it has become the gold standard used by leading hospitals, laboratories and experts worldwide.

"Including p63 in our lung, prostate and breast panels really empowers our Multiplex IHC platform to aid pathologists in making critical decisions and solidifies our passion for patient care and the ability to fight cancer one slide at a time," says Roy Paxton Yih, president & CEO, Biocare Medical, LLC.

"Prostate cancer is one of the most difficult cancers to diagnose, and the p63-based test adds a significant advantage to making the correct diagnosis. We are very excited about our agreement with Ventana, and now Biocare, as it will provide a platform to bring the p63 diagnostic tests to patients worldwide," says Peter F McKeon, president, AsymmetRx Medical, Inc.

Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC lab testing.

AsymmetRx Medical, Inc. is privately held company to develop novel diagnostics, imaging agents, and therapies for urologic cancers including those affecting the bladder and prostate.