sphingotec at the St. Gallen International Breast Cancer Conference
Cambridge, Mass. – Feb. 4, 2015 –
sphingotec LLC announced today that the findings from its research seeking to improve breast cancer risk stratification for guiding hormone replacement therapy has been selected for presentation at the 14th annual St. Gallen International Breast Cancer Conference in Vienna, Austria, March 18 – 21, 2015. The poster will be presented by Dr. Uwe Hantke.
sphingotec’s study assessed how plasma pro-neurotensin (pro-NT) and pro-enkephalin (pro-ENK) help predict whether women have high or low risk for developing breast cancer so physicians can make a more informed decision on whether to use hormone replacement therapy. The results concluded that both plasma pro-NT and pro-ENK provide new and independent information above and beyond commonly known breast cancer risk factors that can improve risk stratification.
As further evidence of the power of pro-NT and pro-ENK risk prediction, a theoretical model demonstrated that 10 out of 123 breast cancer occurrences could have potentially been avoided if clinicians knew their patients’ pro-NT and pro-ENK levels put them in an extremely high-risk group and used this information to avoid HRT.
Although extensive research has been conducted around the risks and benefits of HRT there is disagreement on whether the benefits outweigh the risks. According to The Centers for Disease Control and Prevention (CDC), those who caution against using HRT often refer to the increased risk of endometrial and breast cancer associated with using estrogen, especially for extended lengths of time. Those who advocate for its use often point out that HRT appears to reduce the risk of osteoporosis, heart disease and Alzheimer’s disease in addition to alleviating menopausal symptoms. The controversy surrounding HRT leaves clinicians and their patients feeling uncertain about individual breast cancer risk, one of the most common types of cancer for women.
“Studies have shown that hormone replacement therapy can increase the risk of breast cancer, but it varies greatly based on each woman’s individual characteristics and risk factors,” said Dr. Andreas Bergmann, CEO of SphingoTec GmbH. “There is a huge unmet need for improved risk stratification to help doctors decide whether to recommend hormone replacement therapy. We believe our research will enable doctors and their patients to make a more educated decision on whether this treatment is right for them.”
To conduct the study, sphingotec researchers measured pro-ENK and pro-NT in fasting plasma from 1,929 women participating in the Malmö Diet and Cancer Study and used Cox proportional hazards models to relate pro-ENK and pro-NT to first breast cancer events within 15 years of follow up. For the cohort design, they sampled 1,569 women from the Malmö Preventive Project and used multivariate adjusted logistic regression models to relate pro-ENK and pro-NT to first breast cancer events during the observation period. They then analyzed subgroups of women who received HRT to assess the performance of each marker.
This study supports sphingotec’s mission to reduce the incidence of major illnesses such as cancer, cardiovascular conditions and kidney disease through tests that can detect individual risk factors. sphingotec has developed two simple blood tests, sphingotest® pro-NT and the sphingotest® pro-ENK that identifies the concentration of these peptides in the blood. The biomarkers are independently associated with the development of breast cancer above other commonly known risk factors and are applicable to all females, regardless of genetic predispositions. Both pro-neurotensin and pro-enkephalin assays will be available to the U.S. and European markets later this year.
sphingotec also announced today that the breast cancer biomarkers pro-NT and pro-ENK will be featured in a mid-morning session at the American Association of Clinical Chemistry (AACC) Annual Meeting & Clinical Lab Expo in Atlanta, Georgia July 26 – 30, 2015. A panel of leading researchers will address the gaps and limitations in breast cancer prevention programs and how emerging biomarkers can help clinicians and laboratorians address the key challenges. The panelists are:
Dr. Max Wicha, distinguished professor of oncology and director of the Comprehensive Cancer Center at University of Michigan
Dr. Allan Jaffe, M.D., Mayo Clinic cardiologist and division chair, Clinical Core Laboratory Services
Dr. Alan Maisel, director of the Coronary Care Unit and Heart Failure Program at the VA San Diego Healthcare System, Professor of medicine at University of California, San Diego.
In a prospective, real-world study of 1,436 critically ill ICU patients, proenkephalin A 119–159 (penKid) provided clinically relevant information across AKI severity and during kidney replacement therapy (KRT). PenKid addressed a key unmet need in KRT management by identifying, with greater precision than standard biomarkers, patients at high risk of KRT liberation failure – helping to avoid stopping therapy too early. The findings support a future role for penKid in helping to standardize one of the few intensive care processes where the need for better decision support is widely acknowledged and current tools remain insufficient. Hennigsdorf, Germany – August 27, 2026 – SphingoTec GmbH announces the publication of new real-world data on proenkephalin A 119–159 (penKid) in critically ill patients. The data, published in Annals of Intensive Care, add to the growing body of evidence supporting penKid as a functional biomarker for kidney function and help inform clinical decision-making in AKI and KRT (1). In a prospective observational study at Heidelberg University Hospital, penKid was measured in 1,436 critically ill patients, including 138 patients receiving KRT for liberation analyses. The findings showed that penKid rose with AKI severity and, unlike serum creatinine and urine output, distinguished stage 3 AKI patients with and without an acute KRT requirement. In contrast to serum creatinine, penKid also differentiated acute KRT patients from those with pre-existing kidney failure and on chronic hemodialysis prior ICU admission, even while KRT treatment was ongoing (1). The study further showed that penKid levels increased progressively from the start of KRT, while serum creatinine decreased under treatment. Following successful liberation from KRT, penKid declined, whereas higher levels were seen in cases of liberation failure. In multivariable analysis, penKid was the strongest independent predictor of liberation failure and outperformed serum creatinine. A penKid cut-off of ≥250 pmol/L provided more than 90% specificity for liberation failure (1). By identifying patients at high risk of unsuccessful liberation, penKid may help clinicians make KRT discontinuation decisions more objectively, reduce the risk of stopping therapy too early, and support more standardized decision-making across critical care settings. “These data are important because they address a real-world clinical problem: how to better assess kidney function and support KRT decisions when standard markers fall short,” said Deborah Bergmann, CEO of SphingoTec. “penKid provides clinicians with an objective, real-time measurable parameter that may help support more informed and consistent kidney-related decisions in critical care.” Christian Nusshag, MD, Department of Nephrology, Heidelberg University Hospital, said: “Current markers often leave clinicians with an incomplete picture. Our findings suggest that penKid may help standardize decision-making by providing additional, actionable information on kidney integrity and recovery.” About penKid, scientific insights PenKid is a biomarker that enables real-time assessment of kidney function. Unlike conventional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex. Studies have shown that penKid allows earlier detection of AKI, predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met. This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock. Additionally, penKid has shown potential for monitoring renal recovery under KRT and could help predict successful liberation from KRT. 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 acute heart failure. Discover more on www.sphingotec.com References (1) Gabriel DC, Sauer P, Happel R, et al. Proenkephalin A for Assessing Kidney Integrity and Guiding KRT Liberation Decisions in Critically Ill Patients. Annals of Intensive Care. 2026. DOI: 10.1016/j.aicoj.2026.100113. Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
Hennigsdorf, Germany – August 19, 2026 – Over the coming months, SphingoTec will be present at a series of leading conferences in diagnostics and critical care medicine. These engagements reflect the company’s ongoing commitment to advancing biomarker-driven solutions that support earlier and more precise clinical decision-making in acute and critical care settings. The company’s conference schedule includes: DGAI (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin), September 16-18, 2026, Kassel, Germany Kongress für Nephrologie 2026 (DGFN / Deutsche Gesellschaft für Nephrologie), October 08-11, 2026, Leipzig, Germany ESICM Lives, October 10-14, 2026, Lisbon, Portugal – SphingoTec will co-host a Scientific Symposium together with business partner Boditech, focusing on innovations in sepsis diagnostics. In parallel, new clinical data on penKid in a multicenter sepsis study will be presented as a poster at the ESICM congress. ASN Kidney Week 2026, Denver, CO, USA, October 22–25, 2026 – penKid takes center stage in the poster sessions with the abstract “Proenkephalin Predicts Severe AKI in High-Risk Patients” Medica, November 16-19, 2026, Düsseldorf, Germany – Focus on expanding SphingoTec’s international industry network and advancing partnering opportunities for its biomarker portfolio. DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin), December 2-4, 2026, Hamburg, Germany “These events bring together clinicians, researchers, and industry partners who share our goal of improving outcomes for patients in critical care,” said Deborah Bergmann, CEO of SphingoTec. “By presenting our latest data and engaging in direct dialogue, we aim to strengthen collaborations that translate biomarker innovation into real clinical value.” 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 acute heart failure. Discover more on www.sphingotec.com Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany