sphingotec and GeneNews Limited/Innovative Diagnostics Laboratory (IDL) Sign a Licensing and Cooperation Agreement for the U.S. Market

Cambridge, Mass. – October 14, 2014 – SphingoTec GmbH, headquartered in Hennigsdorf, Germany with U.S. operations in Cambridge, Massachusetts, today announced that it has out-licensed two of its biomarker assays—sphingotest® pro-NT and sphingotest® pro-ENK—to GeneNews Limited (TSX:GEN). The biomarker assays will aid physicians in risk assessment for breast cancer in females in the general population. sphingotec discovers and develops blood tests to detect  cancer, cardiovascular conditions and kidney disease in high-risk patients.
GeneNews expects to add sphingotest pro-NT to the menu of advanced cancer assays offered by its U.S. joint venture, Innovative Diagnostic Laboratory LLP (IDL), by early 2015. GeneNews/IDL will be the first major U.S. laboratory to sell and market sphingotec’s innovative breast cancer risk tests, allowing potentially millions of women to better understand their individual near-term risk of breast cancer. The company is also evaluating the potential expansion of IDL’s testing menu in the area of breast cancer risk prediction through the addition of sphingotest pro-ENK and other biomarker candidates.

GeneNews is committed to helping IDL become a leader in molecular diagnostics and personalized medicine, serving as a strong commercialization outlet for advanced cancer tests. Taking a "multi-view" approach to the diagnosis and treatment of cancer, IDL is working to assemble—through a combination of internal pipeline development, third-party licenses and potential acquisitions—a robust menu of novel, ‎patent-protected cancer assays to be offered throughout the U.S.“We are excited to sign this agreement with GeneNews, especially during Breast Cancer Awareness Month,” said Dr. Andreas Bergmann, founder and managing director of SphingoTec GmbH. “Our partnership will allow sphingotec’s markers to be available to potentially millions of women in the U.S. It is our common goal to lower the incidence of breast cancer by providing tests that are reliable, cost-effective and accessible for patients at risk regardless of health coverage status.”

“sphingotest pro-NT is the third advanced cancer assay added to our offering menu beyond our ColonSentry blood test,” said GeneNews Executive Chairman James R. Howard-Tripp. “We believe sphingotest pro-NT represents a major step forward in breast cancer detection and management, and we are looking forward to making it available to U.S. physicians nationwide through IDL as soon as possible.”

Breast cancer is the second leading cause of cancer death in U.S. women, exceeded only by lung cancer. The American Cancer Society estimates that, in 2014, approximately 232,670 new cases of invasive breast cancer will be diagnosed in women, and approximately 40,000 women will die from the disease. As with most cancers, early identification of high-risk women and intervention are the keys to improved clinical decision making.

Unlike other blood tests on the market that look for genetic indicators for breast cancer, sphingotest pro-NT is a simple blood test for the determination of proneurotensin (pro-NT). sphingotest pro-NT detects the release of the satiety hormone neurotensin and is applicable to all female individuals, regardless of genetic predispositions. A study published in the peer-reviewed Journal of the American Medical Association (JAMA) in October 2012 demonstrated that the determination of proneurotensin levels offered a substantial advantage in prediction of breast cancer (O. Melander et al. [2012]. Plasma Pro-Neurotensin Independently Predicts Cardiometabolic Diseases, Breast Cancer, and Death In Women. Journal of the American Medical Association, 308[14], 1469-1475).

In addition, experts in the fields of breast cancer treatment and biomarker research also support the work sphingotech is conducting.

“Breast cancer risk prediction is a major advancement for science because it’s one of the main ways we can detect and treat high-risk individuals appropriately,” said Dr. Max S. Wicha, MD, professor of internal medicine and director of the University of Michigan’s Comprehensive Care Center. “This could be the future of lowering the incidence of breast cancer.”

“It is exciting to see that inexpensive, blood-based protein biomarkers are now available for detecting women who are at high risk for breast cancer, even when the family history is completely negative,” said Dr. Alan S. Maisel, professor of medicine at the University of California San Diego and director of the Coronary Care Unit and Heart Failure Program at the Veterans Affairs San Diego Healthcare System.