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

sphingotec GmbH, headquartered in Hennigsdorf, Germany with U.S. operations in Cambridge, Massachusetts, recently 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.

“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.”

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 sphingotec 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.

Source: Business Wire

Biomarker Discovery Company, Antigen Discovery Inc., Awarded an NIH Phase I Small Business Innovation Research Grant to Develop a Pan-HIV Protein Microarray Chip

Antigen Discovery Inc. (ADi), a privately held company in Irvine, California, announced the receipt of a National Institutes of Health (NIH) Phase I Small Business Innovation Research award (SBIR) from the National Institute of Dental and Craniofacial Research (NIDCR). The one-year $225,000 award will fund the development of a Pan-HIV Protein Microarray Chip, which will contain every protein in all of the HIV-1 and HIV-2 subtypes and aid in the development of safe and effective vaccines and therapies to prevent HIV infection.

Dr. Xiaowu Liang, President and CEO stated, “ADi is grateful and excited about this SBIR award from the NIDCR. We are pleased to have the opportunity to apply our core platform technology to the development of a Pan-HIV Protein Microarray Chip.”

“The chip will allow rapid characterization of the humoral immune response to all HIV infections and HIV vaccination regimens to identify antibodies against broadly neutralizing epitopes, to provide a useful and much needed tool to aid the development of a safe and effective vaccine to prevent or treat HIV infection and the subsequent progression to AIDS,” added Dr. Douglas Molina, Director of Proteomics at ADi.

“The development of safe and effective vaccine and therapeutics to prevent HIV-1 infection or the subsequent development of AIDS is of the utmost importance,” added Dr. David Camerini, the principle investigator of the grant. “The effort, however, has been hampered by a lack of understanding of the correlates of protective immunity and a lack of the tools needed to measure effective anti-HIV-1 immune responses. The current version of the multi clade HIV-1 (MC-HIV-1) chip, which is available commercially from ADi, contains HIV-1 proteins, protein fragments and epitopes from clades A1, A2, B, C and D. These five clades comprise 74% of HIV-1 infections worldwide. With support of this SBIR award, we will improve the MC-HIV-1 chip by expanding its coverage to >91% HIV-1 infections and virtually all HIV-2 infections globally thereby creating a Pan-HIV Proteomic Chip.”

Source: PR Newswire

bioTheranostics Awarded Medicare Coverage for Breast Cancer Index Molecular Test

bioTheranostics, Inc., a leader in molecular diagnostics for cancer, recently announced that its Breast Cancer Index test has been awarded Medicare coverage. The Centers for Medicare and Medicaid Services posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program.

The Breast Cancer Index is a molecular genomic test that quantifies risk of breast cancer recurrence and predicts which patients have a high likelihood of benefitting from extended endocrine therapy. The Medicare policy covers use of the test to predict risk of late (5-10 years) distant recurrence in women with early stage, estrogen receptor-positive breast cancer who are considering extended therapy but are concerned about continuing anti-hormonal therapy because of documented toxicity or possible significant patient-specific side effects. In addition to new claims, Medicare coverage and payment for the Breast Cancer Index will be made retrospectively for previously submitted claims.

Nicolas Barthelemy, President and CEO of bioTheranostics, said that securing Medicare coverage is a significant achievement and will help ensure broader patient access to an important breakthrough in breast cancer management. “We are pleased that we have attained such a significant milestone within the first eight months of full commercialization of the Breast Cancer Index—the only molecular test covered by Medicare that accurately assesses a patient’s individualized risk of breast cancer recurrence after five years and is validated to identify which patients will benefit from extended hormone therapy,” Barthelemy said. “This critical information will allow many women to avoid unnecessary treatment and potential side effects that can adversely affect their health and quality of life. We appreciate Palmetto GBA’s consideration and diligence in reaching this coverage decision.”

“Women with breast cancer face difficult tradeoffs between wanting to take steps to help prevent the recurrence of their disease and facing significant side effects and costs related to extended endocrine treatments,” said Ruth O’Regan, MD, MRCPI, Director of Translational Breast Cancer Research at the Winship Cancer Institute of Emory University. “The Breast Cancer Index provides important, patient-specific genomic information that helps clinicians identify patients who may not benefit from extended endocrine treatments, allowing them the choice of discontinuing therapy. For patients identified as at higher risk, clinicians now have information that they can use to emphasize the importance of compliance with treatment and establish appropriate follow-up. In light of recently updated ASCO guidelines encouraging consideration of extended endocrine treatment in some breast cancer patients beyond five years, the coverage of this test is particularly timely.”

The Medicare coverage decision was based on a review of the scientific evidence supporting the analytical validity, clinical validity, and clinical utility of the Breast Cancer Index. It is one of the first coverage determinations for a molecular cancer diagnostic technology handed down by the rigorous evaluative process implemented by Palmetto GBA since the inception of MolDx in 2011.

Source: bioTheranostics

SomaLogic Announces Agreement to Place SOMAscan Proteomics Assay in NIH Center for Human Immunology, Autoimmunity and Inflammation

SomaLogic, Inc., recently announced that the National Institutes of Health (NIH) Center for Human Immunology, Autoimmunity and Inflammation (CHI) will use the SOMAscan™ proteomics assay for research with collaborators across the NIH. It is expected that the SOMAscan assay will be installed and fully functional at CHI by the beginning of 2015, under the leadership of CHI Director Neal S. Young, M.D.

“CHI’s mission is to perform cooperative research based on advanced technologies in order to efficiently translate enhanced understanding of immune function and pathophysiology to the clinic,” said Dr. Young. “We believe the SOMAscan assay gives us a powerful new tool to open up proteomics research and biomarker discovery to many more NIH scientists who are performing a wide variety of critical preclinical and clinical studies.”

Compared to other current proteomic technologies, SomaLogic’s offerings provide researchers with unprecedented power for protein biomarker discovery, diagnostics development, and pharmaceutical discovery and development. SOMAmer® (Slow Off-rate Modified Aptamer) reagents, which are at the center of SomaLogic’s proteomics platform, are a new class of superior protein-binding reagents that combine the best properties of both monoclonal antibodies and traditional aptamers. The SOMAscan assay, which incorporates 1129 different SOMAmer reagents, can efficiently, accurately, and rapidly measure proteins across a wide range of concentrations in small volumes of multiple biological sample types.

“We are delighted to partner with NIH to give its world-class researchers access to the SOMAscan assay,” said Byron Hewett, Chief Executive Officer of SomaLogic. “CHI’s commitment to applying our technology to critical biomedical questions will help ensure the accelerated discovery of new biomarkers – and potentially new therapeutic approaches – for many different diseases.”

SomaLogic is continuing to expand access to its SOMAscan assay through its placement in leading academic research centers. Current sites, in addition to CHI, include Massachusetts General Hospital and the University of Pennsylvania, with several more expected to be announced in the coming weeks.

The trans-NIH CHI is sponsored by the National Cancer Institute, the
National Heart, Lung, and Blood Institute, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis, Musculoskeletal and Skin Diseases, the National Institute of Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, the National Eye Institute, the National Human Genome Research Institute, and the Food and Drug Administration. For more information about CHI, please visit
http://www.nhlbi.nih.gov/resources/chi/

Source: SomaLogic

David and Barbara Roux Provide Historic $10 Million Gift to Advance Genomic Medicine Research at The Jackson Laboratory

The Jackson Laboratory (JAX) has announced that technology investor David Roux and his wife Barbara have gifted $10 million to support research and find cures for genetically based diseases. The center will be based at the Laboratory’s locations in both Maine and Connecticut.

The newly announced Roux gift will be used to initiate the creation of the Roux Family Center for Genomics and Computational Biology. This center will be endowed with three new faculty chair positions and a permanent fund for recruiting expert staff and driving research and discovery at the Laboratory. The center will enable scientists to harness the full power of innovative genomic technologies and computational strategies, using them to analyze the human genome and discover new and better ways of preventing and treating disease. The Rouxs’ initial donation of $5 million will trigger a matching gift in their honor by JAX for a total gift of $10 million.

“At a time when public funding for disease research continues to dwindle, David and Barbara Roux have stepped forward to make a truly inspirational statement about the importance of supporting the future of genomic medicine in the shared quest to improve human health,” said Edison T. Liu, M.D., president and CEO of The Jackson Laboratory. “Their gift provides incredibly important leadership in this cause, and we are enormously grateful for their generosity.”

“Barbara and I are tremendously excited by the work that The Jackson Laboratory is doing in the area of genomic medicine,” said David Roux, co-founder and senior director of Silver Lake, one of the world’s leading private equity firms, and a member of the JAX board of trustees. “This remarkable research is transforming the world’s understanding of disease and the search for personalized and precise cures. We are privileged to help support these efforts.”

The Jackson Laboratory is an independent, nonprofit biomedical research institution based in Bar Harbor, Maine, with a facility in Sacramento, Calif., and a new genomic medicine institute in Farmington, Conn. It employs 1,600 staff, and its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.

Source: The Jackson Laboratory