Novel Data on sphingotec’s penKid® Kidney Function Assay to be Presented at 32nd ESICM Annual Congress 2019
Hennigsdorf, Germany, September 26, 2019
- SphingoTec GmbH (“sphingotec”) today announced that novel data on its sphingotest® penKid® assay for Proenkephalin, a unique and proprietary biomarker for real-time assessment of kidney function, will be presented at the 32nd Annual Congress of the European Society of Intensive Care Medicine (ESICM) taking place in Berlin on September 28 to October 2, 2019. In the scientific program of the conference, clinical researchers will present findings from numerous studies investigating the utility of Proenkephalin in various clinical settings using the sphingotest® penKid® microtiter plate assay. To make this innovative test for the management of critically ill patients in acute care setting more readily available, sphingotec plans to launch the test on its proprietary Nexus IB10 point-of-care platform later this year. The IB10 sphingotest® penKid® assay for Proenkephalin will provide test results on whole blood sample in only 20 minutes and can be flexibly deployed in emergency departments, intensive care units and any laboratory setting.
ESICM 2019 Presentations and Posters on Proenkephalin and penKid®
In a session on acute kidney injury, François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France) will present data demonstrating that proenkephalin measured with penKid® at admission of severely ill burn patients is predictive of outcome. In the same session, François Dépret will present data that the penKid® assay could detect sub-clinical acute kidney injury in two independent patient cohorts paving the way for earlier therapeutic intervention. The finding that Proenkephalin is an earlier marker of acute kidney injury compared to creatinine, the current standard test for kidney damage, is further confirmed by data that will be presented by Remi Beunders (Radboud University Medical Center, Nijmegen, the Netherlands).
In sessions on critical care nephrology, François Dépret will present a poster on the prognostic value of kidney biomarkers including Proenkephalin at the time of discharge of patients from the intensive care unit, while Remi Beunders will present an equation that allows estimating glomerular filtration rate, an important parameter of kidney function, in critically ill patients based on Proenkephalin blood levels measured by the penKid® assay.
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Oral Presentations at ESICM 2019
Session: AKI - Epidemiology and early diagnosis, October 1, 2019
“PenKid at admission is predictive of outcome in severely ill burn patients: A report from the PRONOBurn cohort” - presented by François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France)
“Sub-clinical acute kidney injury detection using penKid®: A report from the FROG-ICU and AdrenOSS-1 cohorts”- presented by François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France)
“Proenkephalin, a novel biomarker for kidney function, is earlier in detecting acute kidney injury compared to creatinine” - presented by Remi Beunders (Radboud University Medical Center, Nijmegen, the Netherlands)
Poster Presentations at ESICM 2019
Session: AKI - Critical Care Nephrology 1, September 30, 2019
“One-year prognostic value of kidney biomarkers at discharge from the intensive care unit” – presented by François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France)
Session: AKI - Critical Care Nephrology 2, October 1, 2019
“An equation to estimate glomerular filtration rate in critically ill patients using the novel biomarker proenkephalin” – presented by Remi Beunders (Radboud University Medical Center, Nijmegen, the Netherlands)
About sphingotec
SphingoTec GmbH (“sphingotec”;Hennigsdorf by Berlin, Germany) develops and markets innovativein vitro diagnostic IVD tests for novel and proprietarybiomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec’s assay portfolio includes sphingotest® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of vascular integrity in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signalling pathway disruptions leading to acute organ dysfunction.Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a standard marker portfolio for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.
• 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