Ortho Clinical Diagnostics and sphingotec Announce Strategic Agreement Regarding Novel Biomarker for Decreasing Re-hospitalizations in Heart Failure
HENNIGSDORF, Germany 07. December 2017 — Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, and SphingoTec GmbH today announced a long-term, global strategic agreement regarding the endothelial function marker, biologically active Adrenomedullin (sphingotest® bio-ADM®), which measures patients’ rate of recovery from acute heart failure, providing critical information to physicians making treatment decisions. The agreement allows Ortho to use the sphingotest® bio-ADM® immunoassay on Ortho’s automated VITROS® Immunodiagnostics and Integrated Systems for small-, mid- and high-volume clinical laboratories. Product availability is subject to local regulatory requirements.
“Ortho is committed to the continued expansion of our menu offerings, through both internal research and development programs and strategic collaborations,” said Robert Yates, Ortho’s chief operating officer. “Our strategic agreement regarding the sphingotest® bio-ADM® assay positions us to bring this novel cardiac biomarker to a broad range of clinical labs around the world.”
Congestion in acute heart failure, which is mainly caused by endothelial dysfunction, is a serious medical problem and a main driver of re-hospitalizations in these patients. Next to the wide use of natriuretic peptides mainly for the diagnosis of heart failure, accurate determination of residual congestion during and after treatment is a high unmet medical need, to assess the adequacy of acute heart failure therapy.[1] In particular, residual heart congestion at hospital discharge is associated with a high risk of re-hospitalization and mortality, emphasizing the need for assessing and monitoring the adequacy of decongestion therapy throughout hospitalization.[2] bio-ADM® has been investigated in numerous clinical studies, showing its suitability to accurately diagnose residual congestion, monitor treatment effectiveness and determine suitability of patients for hospital discharge.
"Working with Ortho Clinical Diagnostics will help us deliver our standardized sphingotest® bio-ADM® assay to laboratories around the world to help them efficiently diagnose heart failure patients with residual congestion, in time for meaningful intervention, including a potential change in medication, to take place.” said Andreas Bergmann, founder and general manager of SphingoTec GmbH.
About sphingotest® bio-ADM®
The CE marked sphingotest® bio-ADM® immunoassay from SphingoTec GmbH measures the bioactive form of Adrenomedullin, a peptide-hormone that is essential in maintaining the endothelial barrier function. sphingotest® bio-ADM® is indicated for use as an aid in monitoring de-congestion in patients hospitalized with acute heart failure.
About SphingoTec GmbH
SphingoTec GmbH develops innovative biomarkers for diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, acute kidney injury and circulatory shock, in order to support patient management and provide guidance for treatment strategies. Furthermore, sphingotec develops biomarkers for the prediction of health risks, such as obesity, cardiovascular diseases and breast cancer, in order to support prevention strategies.
For more information, visit www.sphingotec.com
About The VITROS®Systems
The VITROS® Chemistry, Immunodiagnostics and Integrated Systems from Ortho Clinical Diagnostics is a portfolio of products and patented enabling technologies which help clinical laboratories diagnose, monitor and treat disease. VITROS® Products are engineered to help clinical laboratories with organizational, operational and economic challenges.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 125 countries and territories, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com
- Daan Kremer, Biniyam G. Demissei and Adriaan A. Voors (2017) bio-ADM: Novel Marker of tissue Congestion in ADHF Patients. MEMC GREAT Meeting, Lisbon 08-09-2017
- Parinello G. et al. (2015) Heart Fail Rev. January; 20(1): 13–24
- Kremer D. et al. (2017) European Journal of Heart Failure; 19 (Suppl. S1) 5-601
- Costanzo M.R. Heart Fail Rev (2012) 17:313–324
- Sam L. Teichman, Alan S. Maisel, and Alan B. Storrow, (2015) Challenges in Acute Heart Failure Clinical Management: Optimizing Care Despite Incomplete Evidence and Imperfect Drugs. Crit Pathways in Cardiol. 14: 12–24
sphingotec®, sphingotest®, the sphingotec and sphingotest logos and bio-ADM® are registered trademarks of SphingoTec GmbH in Europe. For information regarding trademarks and other intellectual property applicable to this product, please see www.sphingotec.com .
• 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