sphingotec’s biomarker penKid® predicts septic acute kidney injury at time of admission to emergency department
- Sphingotec reports study data demonstrating that its proprietary renal function biomarker penKid® (Proenkephalin) predicts acute kidney injury (AKI), multi-organ failure and mortality in sepsis patients presenting to the emergency department (ED).
- High penKid® plasma levels identified all ED patients with hidden AKI and AKI at admission and reflected worsening of kidney function.
- penKid® point-of-care (POC) implementation in EDs could eliminate current limitations of AKI prediction in septic patients allowing physicians to adjust treatment and therapy monitoring of patients with suspected AKI.
- An automated CE-marked IVD penKid® assay running on sphingotec’s POC platform Nexus IB10 will be launched in Q1 2020.
Hennigsdorf/Berlin, Germany, December 20, 2019 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf Germany) today reported on the publication of novel study results of its proprietary kidney function biomarker penKid® in BMC Emergency Medicine1. The data from a prospective study enrolling 588 septic patients demonstrate that penKid® accurately predicted acute kidney injury (AKI), multiorgan failure (MOF) and mortality in unselected sepsis patients at presentation to the emergency department (ED). Furthermore, increasing penKid® blood levels indicated worsening kidney function.
While organ dysfunction is a hallmark of sepsis, the renal system is being particularly susceptible. One in two patients with septic shock develop AKI and are at increased risk of both severe morbidity and higher mortality. In the current study, the admission levels of penKid® and serum creatinine (SCr) were corelated with patient outcomes. SCr is the current diagnostic standard and is used to calculate the estimated glomerular filtration rate (eGFR), a surrogate parameter quantifying kidney function. In the study, elevated penKid® blood levels at admission predicted all septic patients who developed AKI. Furthermore, high penKid® levels independently from eGFR, identified patients with subclinical AKI at ED admission, who could not be identified by SCr values. penKid® also predicted multiorgan failure and 28-day mortality.
Previously published clinical data from patients with sepsis admitted to intensive care units (ICUs) have provided evidence, that elevated blood levels of penKid® at admission predict AKI, worsening kidney function, organ failure and mortality independently from inflammation and other co-morbidities2. The new results demonstrate that penKid® can also identify AKI patients in a routine ED setting, in which therapy decision making is currently delayed due to the fact that eGFR assessment requires serial measurements2 and creatinine metabolism is affected by inflammation, fluid overload and the use of nephrotoxic agents3-4. Based on the study results, penKid® is a reliable marker for the detection and monitoring of subclinical AKI.
“These study results demonstrate for the first time that penKid® provides physicians at the emergency department with urgently needed information, which is complementary to the current diagnostic toolbox and enables the detection of AKI, particularly in patients with hidden AKI risk,” said Dr. Andreas Bergmann, founder and CEO of sphingotec. “To support timely treatment decisions that are likely to improve outcomes in critical care patient, we will launch in Q1-2020 a fully automated CE-IVD-marked point-of-care penKid® assay on the established Nexus IB10 platform.”
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1. Rosenqvist, M. (2019): Proenkephalin A 119–159 (penKid) – a novel biomarker for acute kidney injury in sepsis: an observational study, BMC Emerg Med. doi: 10.1186/s12873-019-0283-9
2. Caironi P, et al. (2018): Circulating Proenkephalin, acute kidney injury, and its improvement in patients with severe Sepsis or shock. Clin Chem. doi: 10.1373/clinchem.2018.288068
3. Moledina DG, et al. (2018): Phenotyping of acute kidney injury: beyond serum Creatinine. Semin Nephrol. doi: 10.1016/j.semnephrol.2017.09.002.
4. Ronco C. (2016): Acute kidney injury: from clinical to molecular diagnosis. Critical Care. Doi: 10.1186/s13054-016-1373-7.
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, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. 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 cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate 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 IB10 tests for established biomarkers for acute and critical care.
About penKid®
Proenkephalin (penKid®) is a unique and proprietary biomarker for real-time assessment of kidney function. penKid® is a functional kidney marker that works in plasma, is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is a surrogate marker for the gold standard of glomerular filtration rate (GFR) and indicates two days earlier than the standard-of-care the development of acute kidney injury (AKI) in critically ill patients. These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function on intensive care units or emergency departments.
About Nexus Dx Inc. and the IB10 Platform
Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. The IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function and the assay for Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, will be launched later in 2020.
In a prospective, real-world study of 1,436 critically ill ICU patients, proenkephalin A 119–159 (penKid) provided clinically relevant information across AKI severity and during kidney replacement therapy (KRT). PenKid addressed a key unmet need in KRT management by identifying, with greater precision than standard biomarkers, patients at high risk of KRT liberation failure – helping to avoid stopping therapy too early. The findings support a future role for penKid in helping to standardize one of the few intensive care processes where the need for better decision support is widely acknowledged and current tools remain insufficient. Hennigsdorf, Germany – August 27, 2026 – SphingoTec GmbH announces the publication of new real-world data on proenkephalin A 119–159 (penKid) in critically ill patients. The data, published in Annals of Intensive Care, add to the growing body of evidence supporting penKid as a functional biomarker for kidney function and help inform clinical decision-making in AKI and KRT (1). In a prospective observational study at Heidelberg University Hospital, penKid was measured in 1,436 critically ill patients, including 138 patients receiving KRT for liberation analyses. The findings showed that penKid rose with AKI severity and, unlike serum creatinine and urine output, distinguished stage 3 AKI patients with and without an acute KRT requirement. In contrast to serum creatinine, penKid also differentiated acute KRT patients from those with pre-existing kidney failure and on chronic hemodialysis prior ICU admission, even while KRT treatment was ongoing (1). The study further showed that penKid levels increased progressively from the start of KRT, while serum creatinine decreased under treatment. Following successful liberation from KRT, penKid declined, whereas higher levels were seen in cases of liberation failure. In multivariable analysis, penKid was the strongest independent predictor of liberation failure and outperformed serum creatinine. A penKid cut-off of ≥250 pmol/L provided more than 90% specificity for liberation failure (1). By identifying patients at high risk of unsuccessful liberation, penKid may help clinicians make KRT discontinuation decisions more objectively, reduce the risk of stopping therapy too early, and support more standardized decision-making across critical care settings. “These data are important because they address a real-world clinical problem: how to better assess kidney function and support KRT decisions when standard markers fall short,” said Deborah Bergmann, CEO of SphingoTec. “penKid provides clinicians with an objective, real-time measurable parameter that may help support more informed and consistent kidney-related decisions in critical care.” Christian Nusshag, MD, Department of Nephrology, Heidelberg University Hospital, said: “Current markers often leave clinicians with an incomplete picture. Our findings suggest that penKid may help standardize decision-making by providing additional, actionable information on kidney integrity and recovery.” About penKid, scientific insights PenKid is a biomarker that enables real-time assessment of kidney function. Unlike conventional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex. Studies have shown that penKid allows earlier detection of AKI, predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met. This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock. Additionally, penKid has shown potential for monitoring renal recovery under KRT and could help predict successful liberation from KRT. 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 acute heart failure. Discover more on www.sphingotec.com References (1) Gabriel DC, Sauer P, Happel R, et al. Proenkephalin A for Assessing Kidney Integrity and Guiding KRT Liberation Decisions in Critically Ill Patients. Annals of Intensive Care. 2026. DOI: 10.1016/j.aicoj.2026.100113. Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
Hennigsdorf, Germany – August 19, 2026 – Over the coming months, SphingoTec will be present at a series of leading conferences in diagnostics and critical care medicine. These engagements reflect the company’s ongoing commitment to advancing biomarker-driven solutions that support earlier and more precise clinical decision-making in acute and critical care settings. The company’s conference schedule includes: DGAI (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin), September 16-18, 2026, Kassel, Germany Kongress für Nephrologie 2026 (DGFN / Deutsche Gesellschaft für Nephrologie), October 08-11, 2026, Leipzig, Germany ESICM Lives, October 10-14, 2026, Lisbon, Portugal – SphingoTec will co-host a Scientific Symposium together with business partner Boditech, focusing on innovations in sepsis diagnostics. In parallel, new clinical data on penKid in a multicenter sepsis study will be presented as a poster at the ESICM congress. ASN Kidney Week 2026, Denver, CO, USA, October 22–25, 2026 – penKid takes center stage in the poster sessions with the abstract “Proenkephalin Predicts Severe AKI in High-Risk Patients” Medica, November 16-19, 2026, Düsseldorf, Germany – Focus on expanding SphingoTec’s international industry network and advancing partnering opportunities for its biomarker portfolio. DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin), December 2-4, 2026, Hamburg, Germany “These events bring together clinicians, researchers, and industry partners who share our goal of improving outcomes for patients in critical care,” said Deborah Bergmann, CEO of SphingoTec. “By presenting our latest data and engaging in direct dialogue, we aim to strengthen collaborations that translate biomarker innovation into real clinical value.” 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 acute heart failure. Discover more on www.sphingotec.com Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany