International Experts Highlight Demand for Diagnostic Innovations as PenKid's Research and Real-World Data Fuels Quest for Improved RRT Liberation Tools
• International experts recognize the need for diagnostic innovations to support more informed and standardized decisions for liberation from renal replacement therapy (RRT).
• A presentation during the 41st Vicenza Course on AKI-CRRT highlights the promising results of a real-world evaluation of kidney function under RRT with Proenkephalin A 119-159 (penKid).
• Recently published scientific data affirms that penKid remains informative under acute renal replacement therapy (RRT) and can identify patients for successful liberation.
Hennigsdorf/Berlin, Germany, September 6, 2023
– Diagnostic company SphingoTec has announced that a new study and real-world data on its kidney function biomarker penKid underline its potential to monitor kidney function during acute kidney injury (AKI) and RRT and to support liberation decisions from RRT. These findings are especially relevant in the context of a liberation failure rate of up to 50% (1), considering the lack of consensus guidelines, and tools to support clinical decision-making.
Experts advocate for improved tools in critical decision-making
RRT, a common practice in Intensive Care Units (ICUs), has long relied on clinical observations for stop decisions. However, the lack of a dependable biomarker poses challenges in accurately assessing when to discontinue RRT. Considering this, leading experts from the field have discussed in a recent advisory board the importance of identifying the right tools to improve the outcomes in AKI.
According to Claudio Ronco (Director of the International Renal Research Institute of Vicenza, Italy), "The future availability of a reliable biomarker to support stop decisions in RRT is crucial. It has the potential to minimize liberation failure rates and enhance patient care significantly." Lui Forni (Professor and Consultant in intensive care at Royal Surrey County Hospital NHS Foundation Trust and the School of Medicine, University of Surrey) highlights the ethical concerns surrounding unsuccessful liberation, stating, "When patients need to restart RRT after failed liberation, in many cases this will affect the overall patient outcome with an increase in mortality being seen. Therefore, it is imperative that we explore solutions that can help avoid such scenarios." The expert group supports the planning of a prospective study involving penKid as a potential tool to promote uniform treatment standards for RRT liberation.
Advancements in assessing kidney function under RRT
During the 41st Vicenza Course on AKI-CRRT, a presentation by Christian Nusshag (Senior Physician at the University Hospital Heidelberg, Germany) and titled “Real-world evaluation of residual kidney function under RRT - what’s new?” introduced the latest insights emerging from real-world data.
Dr. Nusshag highlighted, "In the realm of AKI, there is a recognized need for relevant biomarkers that can accurately assess kidney function, especially in the context of RRT. The data we generated with penKid during our real-world evaluation at University Hospital Heidelberg, allowed us to observe that penKid seems not to be affected by RRT procedure, as standard markers are. In this case, penKid may help to identify patients at high risk for liberation failure or patients with unnecessary prolongation of RRT, potentially supporting successful RRT liberation decisions in the future."
Recently published data support these real-world findings. The post-hoc analysis of the multicentric RICH trial show that penKid may be a competent biomarker to monitor the recovery of kidney function during continuous RRT (CRRT) and identify patients for liberation from CRRT (2). This aligns with data from the ELAIN trial, where penKid showed the potential to guide early and successful liberation of treatment (3).
Dr. Florian Uhle, Medical Director at SphingoTec comments, “PenKid’s ability to provide patient-specific insights for informed clinical decision-making opens exciting possibilities in monitoring kidney function in critically ill patients, as it mirrors the real-time glomerular filtration rate in non-stable settings. The potential of penKid in kidney health assessment opens new avenues for personalized medicine in AKI.”
##
References:
(1) Schiffl H, et al. Current Approach to Successful Liberation from Renal Replacement Therapy in Critically Ill Patients with Severe Acute Kidney Injury: The Quest for Biomarkers Continues. Mol Diagn Ther. 2021 Jan;25(1):1-8. doi: 10.1007/s40291-020-00498-z.
(2) von Groote T et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). https://doi.org/10.1186/s13054-022-04217-4
(3) von Groote T, et al. Evaluation of Proenkephalin A 119-159 for liberation from renal replacement therapy: an external, multicenter pilot study in critically ill patients with acute kidney injury. Crit Care. 2023 Jul 10;27(1):276. doi: 10.1186/s13054-023-04556-w.
About SphingoTec
SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for the diagnosis, prediction, and monitoring of 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.
Media contact:
Ruxandra Lenz
Head of Marketing and Communication
SphingoTec GmbH
Neuendorfstr. 15 A
16761 Hennigsdorf
Tel. +49-3302-20565-0
• 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