Beckman Coulter and SphingoTec Partner to Improve Kidney Health Assessment in Critical Care
• Alliance marks first penKid licensing agreement for high throughput immunoassay.
• Partnership leverages SphingoTec's proficiency in acute kidney injury testing, and Beckman Coulter’s extensive, globally installed Access Family of immunoassay analyzers.
HENNIGSDORF/BERLIN, GERMANY — October 9, 2024:
Diagnostic company SphingoTec GmbH (“SphingoTec”) today announced a new partnership with Beckman Coulter Diagnostics Inc.(“Beckman Coulter”). Through this collaboration, the companies will bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers. This alliance marks the first central laboratory license for a penKid assay and aims to significantly enhance the diagnostic capabilities for acute kidney injury (AKI) globally, by leveraging Beckman Coulter’s global installed base of instruments.
PenKid is a real-time biomarker in plasma designed to address critical gaps in the standard diagnostic practices for AKI, particularly in critical care environments. Specifically, scientific evidence shows that, unlike current methods, a penKid assay offers early detection of kidney function decline, unaffected by inflammation, potentially enabling earlier intervention and improved patient outcomes (1,2,3). The incidence of AKI is increasing in both hospital and community settings; it is estimated that more than 13 million people are affected by AKI annually worldwide (4, 5).
Under the terms of the agreement, Beckman Coulter will develop and validate a fully automated diagnostic test for penKid, leveraging SphingoTec’s IVD certified assay. This assay has already been implemented as a routine test in the first university hospitals. This collaborative effort will facilitate high-throughput availability of penKid assays in central laboratories, supporting critical care physicians with the ability for timely and precise kidney health assessment.
“Acute kidney injury exerts a profound impact on patients globally, complicates acute and chronic illnesses frequently resulting in poor outcomes, and rivals many other critical diseases in its severity and consequences,” said Kevin O’Reilly, President, at Beckman Coulter Diagnostics. “The published evidence for penKid testing combined with SphingoTec’s scientific expertise provides an exciting opportunity to improve kidney health management. Working with SphingoTec, our goal is to expand access to and improve workflow from this important kidney health innovation underscoring our commitment to enhancing patient care worldwide.”
Deborah Bergmann, Managing Director and CEO of SphingoTec, emphasized, “The development of a penKid-based assay for use on Beckman Coulter’s globally installed immunoassay platforms represents a significant step toward realizing our vision of transforming diagnostic innovation into tangible patient benefits. This partnership accelerates our mission to deliver precise, actionable insights to clinicians worldwide, ultimately improving outcomes for patients suffering from acute kidney injury.”
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References:
(1) Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006
(2) Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) https://doi.org/10.1373/clinchem.2018.288068
(3) Lin, LC., et al. Proenkephalin as a biomarker correlates with acute kidney injury: a systematic review with meta-analysis and trial sequential analysis. Crit Care 27, 481 (2023). https://doi.org/10.1186/s13054-023-04747-5
(4) Mehta RL et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. Lancet. 2015 Jun 27;385(9987):2616–43. http://dx.doi.org/10.1016/S0140-6736(15)60126-X
(5) Susantitaphong P et al. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482–93. http://dx.doi.org/10.2215/CJN.00710113
About SphingoTec
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec’s innovative markers are made 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
Contact:
Ruxandra Lenz
Head of Marketing and Communication
SphingoTec GmbH
Phone +49-3302-20565-0
Email: ruxandra.lenz@sphingotec.com

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
