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.
• New ELISA sphingotest® penKid® enables widespread measurement of the kidney function biomarker Proenkephalin 119-159 (penKid) using standard laboratory equipment. • Only available test to match SphingoTec’s reference chemiluminescence assay, developed with patented high-sensitivity technology to provide consistent results across platforms. Hennigsdorf/Berlin, Germany, April 28 2026 - SphingoTec GmbH announces the launch of the ELISA sphingotest® penKid®, a new assay designed to make testing of its proprietary biomarker broadly accessible to research laboratories and pharmaceutical partners. Providing ease-of-use and precision, the test facilitates large-scale investigations of human kidney function in both acute and broader clinical research contexts. Responding to growing research interest The launch follows increasing demand from the scientific community to study penKid - a biomarker reflecting the current state of kidney function in critical care environments. While SphingoTec’s high-sensitivity sphingotest® penKid® assay serves as the reference method for clinical research and third-party IVD assays, the assay technology requiring dedicated equipment was not easily adoptable in research laboratories. The new ELISA sphingotest® penKid® now allows researchers worldwide to benefit from SphingoTec’s patented detection technology using standard photometers, extending penKid testing capability to a wider range of laboratories. Proven performance and data continuity The ELISA sphingotest® penKid® has been developed to achieve excellent correlation with SphingoTec’s reference chemiluminescence assay, ensuring consistent, high-quality results across different assay platforms. Both methods share the same underlying technology capable of detecting penKid concentrations in the picomolar range. Thanks to this technology transfer, researchers can rely on the same analytical precision and reliability that supported the clinical studies establishing penKid as a valuable kidney function biomarker. The assay’s robust design and German manufacturing ensure durable consistency and reproducibility. With this research-use ELISA, SphingoTec responds to the increasing availability of non-validated assays and encourages researchers to not compromise assay quality and performance to ensure trustworthy results - since data from non-validated tests may reflect assay limitations rather than the true performance of the penKid biomarker. Complementary approaches for clinical use and scientific exploration SphingoTec pursues its commercial strategy for the biomarker penKid through strategic out-licensing partnerships such as Boditech Med, which has developed an IVDR-certified assay for routine clinical use and rapid diagnostics. The newly launched ELISA sphingotest® penKid® represents a complementary initiative, specifically designed to support high-throughput clinical and translational research. Through this dual approach, SphingoTec reaffirms its commitment to fostering scientific collaboration and promoting the broader exploration of penKid across diverse research settings. “Developing the ELISA sphingotest® penKid® reflects our long-term commitment to improving critical care diagnostics,” said Deborah Bergmann, Managing Director and CEO of SphingoTec GmbH. “Beyond its currently validated clinical applications, we see strong potential for penKid to support research and improve diagnostics in other fields where kidney function is relevant. By encouraging scientists worldwide to incorporate penKid into their studies and clinical programs, we aim to accelerate innovation and advance best-fit diagnostic solutions that ultimately improve patient care.” About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a biomarker company focusing on the out-licensing of innovative critical care solutions for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec develops its biomarkers to the commercial stage and partners with IVD companies to make them available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
• PenKid surpasses serum creatinine on Day 1 post-transplant in detecting delayed graft function (DGF), with an AUROC of 0.87 versus 0.56 for creatinine. • PenKid differentiates slow graft function (SGF) from DGF up to 8 days earlier than current methods, supporting more timely clinical decisions. • PenKid levels remain unaffected by kidney replacement therapy (KRT), allowing for more accurate assessment of kidney function. • Independent validation in transplant cohort from Australia confirms performance and broad applicability. Hennigsdorf/Berlin, Germany, July 1, 2025 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces a landmark study (1) published in Transplant International, led by Heidelberg University Hospital in Germany in collaboration with researchers from Sydney, Australia, which identifies Proenkephalin A 119-159 (penKid) as a reliable biomarker for early and precise assessment of graft function trajectories following kidney transplantation. The research demonstrates that PenKid not only identifies patients at risk for DGF significantly earlier than traditional markers but also distinguishes between slow and delayed graft function with remarkable accuracy, offering clinicians a valuable new tool for patient management. The study prospectively evaluated 159 consecutive kidney transplant recipients at Heidelberg University Hospital and validated findings in an independent cohort from Sydney. PenKid consistently outperformed serum creatinine (SCr) in predicting graft function trajectories, particularly in the critical early post-transplant period. Notably, PenKid’s ability to remain unaffected by KRT—a treatment for severe kidney dysfunction—further sets it apart from SCr, which can be influenced by non-renal factors and KRT itself, thereby enhancing the reliability of graft function assessment. Multivariate analysis confirmed PenKid as the strongest independent predictor of both short-term graft function and 30-day outcomes, underscoring its clinical utility for early risk stratification. The biomarker’s superior granularity allows for nuanced classification of DGF severity, supporting more informed decisions regarding the initiation of dialysis or biopsy and offering potential for individualized patient care. With these findings, penKid steps forward as a practical addition to the transplant clinician’s toolkit, promising to sharpen decision-making for optimal outcomes. Its adoption could help transplant teams act with greater confidence and precision, ultimately strengthening the standard of care in kidney transplantation. ## References 1. Benning L et al. (2025) Proenkephalin A 119-159 in Kidney Transplantation: A Novel Biomarker for Superior Tracking of Graft Function Trajectories. Transpl. Int. 38:14366. doi: 10.3389/ti.2025.14366 About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a biomarker company focusing on the out-licensing of innovative critical care solutions for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec develops its biomarkers to the commercial stage and partners with IVD companies to make them available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, commercially available on diagnostic platforms AFIAS and Nexus IB10 and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com Contact : Ruxandra Lenz Marketing and Communication SphingoTec GmbH Phone +49-3302-20565-0 Email: press@sphingotec.com