Interdepartmental testing of the kidney function biomarker penKid in routine care at Heidelberg University Hospital and the Heidelberg Kidney Center
- Acute kidney injury (AKI) is a complex syndrome, which results in a rapid loss of kidney function, affecting 1 in 5 patients (1) during hospitalization.
- Four units at the University Hospital Heidelberg and Heidelberg Kidney Center implement Proenkephalin (penKid) in a pilot biomarker-based treatment approach to diagnose AKI faster and monitor it more accurately across departments.
- PenKid is a proposed biomarker for real-time kidney function that potentially closes on the gaps of the standard diagnostic procedures.
Hennigsdorf, Germany, August 26, 2022 -
The diagnostic company SphingoTec GmbH (SphingoTec) announces the introduction of novel biomarker penKid in the clinical routine management of patients on a test basis in a total of four units at the University Hospital Heidelberg (UKHD) and Heidelberg Kidney Center (NZH). This includes the normal, the intermediate care (IMC), the nephrology, and the intensive care units (ICU) of both clinics in Heidelberg. According to recent data, the new diagnostic tool provides a faster and more accurate assessment of kidney function than current practice and aims to improve the management of patients with AKI. The condition is associated with high morbidity and mortality, and is a frequent complication of severe diseases, such as sepsis.
The pilot implementation of penKid was started in cooperation with the Clinic for Anesthesiology at UKHD and the NZH with the long-term goal of improving the monitoring of patient’s kidney function. This routine use of penKid on a centralized level in the hospital drives innovation on multiple wards such as nephrology, ICU and IMC. The biomarker will be used on top of standard of care, in order to compare penKid with the existing standard diagnostics. Better and faster information assessment of kidney function helps detect AKI earlier, so that prompt action can be taken to protect renal function and improve patient prognosis.
Prof. Dr. med. Martin Zeier, Medical Director at NZH added, “After the first experience of penKid on the point of care analyzer from SphingoTec, we have decided to implement it in the central laboratory to apply the test in more patients at the same time. The goal is to investigate the added value compared to established renal function parameters in routine diagnostics. To date, our data suggest better and more direct information about kidney function, which may allow for more rapid action. Acute kidney injury is a serious condition that needs to be detected early and counteracted promptly. When the critically ill patients are undergoing renal replacement therapy, the decision to terminate the treatment is of high importance for the success of the therapy. With penKid we may achieve better insights that complement our current practices, and we have strong hopes that this will help us improve patient outcomes on short and long term.”
PenKid is a promising biomarker to determine kidney function. It has been studied in over 55,000 patients showing the potential to reflect kidney function in real-time (2,3). Data from the PredARRT-Sep-Trial enrolling patients hospitalized in the surgical ICU of UKHD showed that penKid is a kidney function biomarker with rapid kinetics. According to these findings shared with the scientific community during the AKI&CRRT 2021 conference in San Diego US (4), penKid especially indicates changes in kidney function more dynamically than established functional markers. For those patients in critical conditions who require dialysis, penKid seems to be an early indicator of the kidney function and a potential tool to monitor kidney function and recovery during dialysis.
Prof. Dr. med. Markus Weigand, Medical Director of the Clinic for Anesthesiology at UKHD commented “On the ICU we experience the extreme of human disease, and AKI remains a serious complication in critically ill patients. A biomarker alerting changes in the kidney function faster than the currently known standards and uninfluenced by inflammation, has a significant potential for improving patient management. The sooner we identify a patient with kidney dysfunction, the faster we can intervene with life-saving procedures.”
Dr. Andreas Bergmann, founder and CSO of SphingoTec added “Testing penKid in routine practice at University Hospital Heidelberg brings the scientific advancements directly to those needing them the most: the patients. AKI is usually diagnosed after symptoms manifest, with diagnostic tests that have limited ability to identify early the onset of the disease. The blind spots in diagnosing kidney dysfunction are well known to the medical community, therefore penKid is a functional biomarker that addresses a clear unmet need and provides actionable information on all stages of the disease evolution.”
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References:
1. Wang HE, Muntner P, Chertow GM, Warnock DG. Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-55. doi: 10.1159/000337487. Epub 2012 Apr 2. PMID: 22473149; PMCID: PMC3362180.
2. Beunders R et al. Proenkephalin Compared to Conventional Methods to Assess Kidney Function in Critically Ill Sepsis Patients. Shock. 2020;54(3):308-14.
3. Donato LJ et al. Analytical performance of an immunoassay to measure proenkephalin. Clin Biochem. 2018;58:72-7
4. https://www.crrtonline.com/conference/support/AKI&CRRT2021_Syllabus.pdf
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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. 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 cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate 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 established and commonly used tests for acute and critical care.
Media contact:
Ulrike Glaubitz
Sr. Public relations specialist
SphingoTec GmbH
Neuendorfstr. 15 A
16761 Hennigsdorf
Tel. +49-3302-20565-0
press@sphingotec.com
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