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.
• 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
• Boditech Med and SphingoTec announce the launch of the AFIAS sphingotest® penKid® assay, a diagnostic tool designed to aid in kidney function assessment for critically ill patients. • The IVDR-marked assay provides quantitative measurements of Proenkephalin A 119-159 (penKid), supporting clinical decision-making in acute and critical care. • This launch follows a licensing agreement granting Boditech the rights to develop and commercialize penKid-based assays, as well as a market development agreement between the two companies. Gangwon-do, Republic of Korea, and Hennigsdorf/Berlin, Germany, May 6, 2025 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced the commercial launch of the AFIAS sphingotest® penKid® assay. The assay is designed to provide clinicians with a tool for assessing kidney function in critically ill patients by measuring Proenkephalin A 119-159 (penKid), a biomarker that reflects real-time kidney function independently of inflammation or comorbidities. The AFIAS sphingotest® penKid® assay is IVDR-marked for its intended use as an automated fluorescence immunoassay for the in vitro diagnostic quantitative determination of Proenkephalin A 119-159 in human whole blood/plasma, serving as an aid in the diagnosis of acute kidney injury (AKI) in adult patients with sepsis or septic shock. It provides additional information to support clinical decision-making in managing critically ill patients at risk of acute kidney injury (AKI). This launch is the result of a strategic collaboration between Boditech and SphingoTec, including a licensing agreement granting Boditech the rights to develop and commercialize penKid-based assays on its diagnostic platforms, as well as a market development agreement aimed at accelerating global commercialization efforts. Eui-Yul Choi, CEO of Boditech Med, commented: “We are proud to introduce the AFIAS sphingotest® penKid® assay to clinicians worldwide. This launch reflects our commitment to delivering innovative diagnostic solutions that address critical needs in healthcare. Our collaboration with SphingoTec has been instrumental in bringing this important tool to market.” Deborah Bergmann, CEO of SphingoTec, added: “The launch of AFIAS sphingotest® penKid® demonstrates how partnerships can drive innovation and improve access to advanced diagnostics. By combining our biomarker expertise with Boditech’s diagnostic capabilities, we are reaching a new chapter in our collaboration. We are streamlining our processes to support the business of our license partners and further expand our global reach. This enables us to provide clinicians with essential tools to enhance patient care.” Scientific insights on penKid PenKid is a biomarker that enables real-time assessment of kidney function (1). Unlike traditional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex (1,2,3). Studies have shown that penKid allows earlier detection of acute kidney injury (AKI), predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met (1,3). This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock (1,3,4). Additionally, penKid has shown potential for monitoring renal recovery under dialysis and could help predict successful weaning from renal replacement therapy (5,6). ## References 1. Hollinger A, et.al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006. 2. Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006 3. Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) DOI:10.1373/clinchem.2018.288068 4. Moledina DG. Penkid: A Novel Biomarker of Reduced GFR in Sepsis. Kidney Int Rep. 2018 Nov 15;4(1):17-19. doi: 10.1016/j.ekir.2018.11.002. 5. 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). doi.org/10.1186/s13054-022-04217-4 6. 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 Boditech Boditech Med (based in Chuncheon, Gangwon-do, Republic of Korea) is a leading company in the field of point-of-care diagnostics, which has accumulated 25 years of business expertise in the field. The company has more than 80 types of in vitro diagnostic products that detect biomarkers related to infectious diseases, diabetes, cardiovascular diseases, cancer, and hormone-related diseases with its immunofluorescence lateral flow technology, quantitative immunofluorescence technology and spectrophotometric technology. And the list continues to grow with new high-value-added products. With its instrument platform installed in more than 120 countries, the company also has a stable revenue model. The company is currently strengthening its value as a global company by expanding its manufacturing bases in the US, China, India, and Indonesia. About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a diagnostic company focusing on the out-licensing of innovative critical care biomarkers 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 Head of Marketing and Communication SphingoTec GmbH Phone +49-3302-20565-0 Email: press@sphingotec.com