Novel Data on SphingoTec's Biomarkers for acute and critical care setting to be presented at AKI & CRRT 2020
- Numerous talks and posters on sphingotec’s acute care biomarkers in the scientific program of the conference
- sphingotec to host symposium “Relevant Pathways, Novel Diagnostic and Therapeutic Approaches in Acute Organ Dysfunction”
Hennigsdorf, Germany, February 21, 2020
- SphingoTec GmbH (“sphingotec”) today announced that novel data on its acute care biomarkers Proenkephalin (penKid®) and Dipeptidyl Peptidase 3 (DPP3) will be presented at the 25th International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2020) taking place in San Diego, CA, USA, on February 24-27, 2020.
AKI & CCRT 2020 Presentations on penKid® and DPP3
In the scientific program of the conference, clinical researchers will present the latest results from studies investigating these two critical care biomarkers and their utility in diagnosing kidney injury. In a session on translating biomarker discoveries to clinical care, Peter Pickkers (Radboud University | RU · Department of Intensive Care, Nijmegen, The Netherlands) will present data demonstrating that sphingotec’s kidney function marker penKid® is a reliable surrogate for assessing true glomerular filtration rate (true GFR) in patients with renal insufficiency. Previous studies demonstrated that penKid® is a real-time kidney function biomarker, which is independent of inflammation and other co-morbidities. In another session, Matthieu Legrand (University of California, San Francisco | UCSF · Department of Anesthesia and Perioperative Care, USA) will provide evidence showing that sphingotec’s biomarker DPP3 is one cause for short-term kidney dysfunction and is highly associated with the development of acute kidney injury (AKI) in patients with severe burns. Being at the core of a newly discovered disease mechanism, DPP3 has been shown to play a causal role in short-term organ dysfunction when released into the bloodstream upon massive cell death in several acute and critical care conditions.
Sphingotec Symposium at AKI & CCRT 2020
In a symposium organized by sphingotec titled “Relevant Pathways, Novel Diagnostic and Therapeutic Approaches in Acute Organ Dysfunction” leading clinical researchers will further discuss pathways leading to acute organ dysfunctions in critically ill patients as well as a novel diagnostic solution to assess the involvement of such pathways in acute and critical care conditions. Beyond providing an overview of novel biomarkers for monitoring kidney function, endothelial function, and DPP3-mediated heart and kidney dysfunction, the speakers will also share findings that are qualifying these biomarkers as biotargets.
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Oral Presentations at AKI & CRRT 2020
Session: Bench to Bedside: Translating Discoveries to Clinical Care, February 24, 2020
“Proenkephalin: Is it the New GFR Marker?” presented by Peter Pickkers (Radboud University | RU · Department of Intensive Care)
Session: Acute Kidney Injury (AKI): Pathophysiology, February 25, 2020
“DPP3 in Critical Illness: Another Piece of the Puzzle” presented by Matthieu Legrand (University of California, San Francisco | UCSF · Department of Anesthesia and Perioperative Care)
Poster Presentation at AKI & CRRT 2020
Title: Proenkephalin, a Novel Biomarker for Kidney Function, is Earlier in Detecting Acute Kidney Injury Compared to Creatinine.
Authors R Beunders, M Meekes, J Struck, P Pickkers
Title: Proenkephalin Predicts Renal Dysfunction, Organ Failures, Renal Replacement Therapy, and Mortality in Sepsis
Authors H Kim, M Hur, J Struck, A Bergmann, S Di Somma
Title: penKid Proenkephalin A 119–159 effectively predicts Acute Kidney Injury, Multiple Organ Failure, Mortality particularly among septic patients at the ER with seemingly intact renal function
Authors M Rosenqvist, K Bronton, O Hartmann, A Bergmann, J Struck & O Melander
About sphingotec
SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

• 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
