sphingotec announces new data on the kidney function marker proenkephalin (penKid®) presented at 24th International Conference on Advances in Critical Care Nephrology
sphingotec announces new data on the kidney function marker proenkephalin (penKid®) presented at 24th International Conference on
Advances in Critical Care Nephrology
- Medical leaders in renal critical care presented study data at the 24th AKI & CRRT conference supporting the hypothesis that plasma penKid® levels reflect kidney function in critically ill burn patients, heart failure patients, and sepsis patients closing the gap to near-time diagnosis and monitoring of acute kidney injury (AKI).
- Peer-reviewed results from the Valsartan Heart Failure Trial (Val-HeFT) comparing the biological variation of renal biomarker tests demonstrate that sphingotest® penKid® is the very first diagnostic test capable to rule out AKI with a single measurement and best-in-class in terms of early diagnosis.
- Medical leaders recommend to include low penKid® levels as exclusion criterion for AKI in triaging and for routine testing at emergency departments.
- Critical care experts announced to evaluate clinical utility of sphingotest® penKid® in renal transplant function/dysfunction.
- Automated point-of-care (POC) penKid® testing on NEXUS IB 10 platform to be launched at intensive care units (ICUs) and emergency departments (EDs) by summer 2019.
HENNIGSDORF, GERMANY - March 14, 2019
- German diagnostics company SphingoTec GmbH (Hennigsdorf) announced that leaders in critical care nephrology have confirmed clinical utility of the company’s glomerular filtration biomarker penKid® for early diagnosis, exclusion and monitoring of acute kidney injury (AKI). Data from prospective, observational studies presented at the 24th International Conference on Advances in Critical Care Nephrology (AKI & CRRT; 26 Feb-1 March, 2019) in San Diego demonstrate that penKid® is suitable to guide treatment decisions at ICUs and EDs.
At the AKI & CRRT conference, Prof. Matthieu Legrand (Critical Care Medicine & Burn Unit at Hôpital Lariboisière Paris, France) reported results from a substudy of the PRONOburn cohort that enrolled 113 burn patients admitted to burn intensive care units (ICUs). High penKid® levels at admission (> 80 pmol/L) were sufficient to predict acute kidney injury (AKI) even when other indicators such as the SOFA score gave no sufficient information (p<0.001). In sepsis patients, enrolled in the FROG-ICU and AdrenOSS-1 cohorts, including more than 1,100 patients, elevated penKid® plasma levels identified sub-AKI while creatinine values remained normal (1 out of 4 patients). Sub-AKI was associated
with worse outcomes.
Peer-reviewed data [1] on the biological variation of four AKI biomarker tests in patients with stable heart disease presented by Dr. Alan Wu (UCLA, San Francisco) demonstrated that penKid® is best suited for early diagnosis of renal insufficiency in clinical practice. Data from 85 individuals enrolled in the Valsartan Heart Failure Trial (Val-HeFT) support that penKid® testing would be of value in managing patients in EDs and ICUs. Commenting on the results, key opinion leaders suggested to add penKid® measurements to AKI routine testing for triaging and monitoring, which today only allows delayed information using available biomarkers.
“The biovariability of a biomarker is a key attribute, but not tested for many of the novel kidney markers. penKid® shows a low variability – allowing information with the first measurement,” said Dr. Wu. “penKid® has a huge value to rule out patients in EDs,” confirmed Prof. Salvatore Di Somma, Head of Emergency Medicine Sant'Andrea Hospital, Rome, Italy. sphingotec showed data from pilot routine testing, which has already begun at undisclosed ICUs and EDs in Germany. Study leaders confirmed that triaging will be supported by penKid® information, because the marker can rule out AKI as BNP rules out Heart Failure. David Bruno, Director of the University of Maryland Transplant Surgery Program announced starting tests with penKid® to predict graft function recovery in kidney transplantation.
Plasma penKid® is a surrogate marker for disturbed renal glomerular filtration rate (GFR), which reflects kidney function. Previous studies on more than 30,000 critically ill patients admitted to EDs or ICUs with congestive heart failure [2] or sepsis [3] demonstrated that penKid® levels change dynamically with the actual kidney function independently from comorbidities or inflammation [4]. penKid® levels rise up to 48 hours prior to those of creatinine preceding kidney injury (AKI), which affects about 25 percent of patients admitted to ICUs.
By the end of H1/2019, sphingotec will launch a penKid® point-of-care (POC) test on its fully automated Nexus IB10 POC testing platform for use in EDs and ICUs. The platform allows measurement of up to five critical care biomarker tests in one run within 20 minutes without any sample preparation.
[1] Wu, A., Anand, I. (2018) Biological variation of plasma proenkephalin: data from a stable heart failure cohort.
[2] Chan S. et al. (2018) Proenkephalin in Heart Failure; Kanagala P. et al.: Proenkephalin and prognosis in heart failure with preserved ejection fraction: a GREAT network study.
[3] Hollinger et al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Press Release Kidney in Sepsis and Septic Shock (Kid-SSS) Study
[4] Beunders, R. et al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.
About SphingoTec GmbH:
SphingoTec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bioADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, in addition is developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.
About International Conference on Advances in Critical Care Nephrology:
The AKI & CRRT conference provides a comprehensive review of advances in clinical care, research and technology in critical care medicine with a focus on the
kidney and renal support techniques.
About penKid®:
penKid® is the very first functional kidney marker that works in blood. penKid® is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR). These features enable physicians to diagnose and closely monitor worsening and improving kidney function in critically ill patients.
• 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