Sphingotec’s critical care biomarkers early diagnose risk of loss of endothelial, kidney and heart function in severely ill COVID-19 patients
- Results of a consensus meeting of clinical experts investigating sphingotec’s diagnostic solutions for acute and critical care in COVID-19.
- sphingotec’s biomarkers penKid, bio-ADM, and DPP3 previously shown to predict the need for organ support in numerous critical care conditions also have utility in risk stratification of severely ill COVID-19 patients.
Hennigsdorf/Berlin, Germany, June 18, 2020
– Diagnostics company SphingoTec GmbH (“sphingotec”) announced today the results of a working group meeting of clinical experts that discussed the utility of sphingotec’s diagnostic solutions for acute and critical care in supporting the triage, diagnosis, and management of severely ill COVID-19 patients. The experts representing European medical centers agreed that novel biomarkers are required for triaging and monitoring of these patients to optimally make use of the available medical resources and improve outcomes.
Diagnostic tests for sphingotec’s organ-specific biomarkers for monitoring the endothelial and kidney function are currently investigated on-site in COVID-19 patients in hospitals in Germany, Switzerland, United Kingdom, France and Italy. Serial measurements of sphingotec’s real-time endothelial function biomarker bio-ADM, kidney function biomarker penKid and cardiac depressant factor DPP3 were performed in these centers to investigate their utility in the management of COVID-19 patients. In a working meeting, the investigators discussed their initial findings to develop a consensus on the diagnostic needs for severely ill Covid-19 patients and how sphingotec’s biomarkers can address these needs.
Prof. Thorsten Brenner (Essen University Hospital/Essen, Germany) commented: “To identify high risk patients, we need early and specific markers for organ failure to be measured already in the emergency departments. PenKid is a very promising biomarker that we are currently investigating for the triage and the monitoring of organ support therapies of COVID-19 patients with impaired kidney function.”
Previously gathered evidence confirmed the central role of bioactive Adrenomedullin and endothelial function in sepsis patients. First feedback on the biomarker bio-ADM in severe COVID-19 describes a strong correlation between high bio-ADM blood levels and the severity of the disease and the need for organ support which can assist in a more accurate and objective risk stratification.
Further investigations with DPP3, penKid and bio-ADM are ongoing in countries strongly affected by the COVID-19 pandemic, such as France, Italy and United Kingdom as well as in the United States and Asia. The main objective is to confirm the utility of sphingotec’s biomarkers in the management of COVID-19 patients.
Dr. Marlies Ostermann, MD, PhD (Guy’s & St Thomas’ Hospital/London, United Kingdom) commented: “There is an urgent need to assess and monitor organ function of COVID-19 patients in real- time. After a first positive evaluation of these novel biomarkers we have decided to further investigate their use in clinical practice. Especially in the intensive care units, we need biomarkers for monitoring of organ support therapies. This information will also enable us to develop strategies for individualized management of this high-risk group.”
The rapidly evolving COVID-19 pandemic has challenged health systems world-wide, with about 5% of patients requiring admission to intensive care units (ICU). Among the main complications that include respiratory, cardiovascular and kidney diseases, an emerging body of evidence shows that endothelial function (1) plays a central role in severe COVID-19 patients. Previous clinical data from more than 22,000 patients demonstrate that high bio-ADM levels independently from inflammation and co-morbidities indicate distortions in the endothelial barrier function, the inner cell sheet of blood vessels. Loss of this barrier function is considered a key driver in the development of hypotension and subsequent septic shock with loss of organ perfusion in sepsis patients (2). According to a Chinese Study in Wuhan, among the non-surviving COVID-19 patients, sepsis was present in all cases (3).
Another frequently occurring complication in COVID-19 patients is loss of kidney function. Proenkephalin (penKid) has been demonstrated to be the most accurate surrogate marker for true glomerular filtration rate in patients with renal impairment, without being biased by co-morbidities.
DPP3, sphingotec’s novel biomarker for hemodynamic instability and cardiac depression, is a major cause of short-term organ failure when released in an uncontrolled manner into the blood stream. Previously published data (4,5) has shown that high blood levels of DPP3 strongly predict poor outcome in patients with cardiogenic shock.
Dr. Andreas Bergmann, founder and CEO of sphingotec said: “To support the critical care community in the management of acute care patients, including COVID-19 patients, we have made available rapid tests for our biomarkers penKid®, bio-ADM® and DPP3 on our whole-blood Nexus IB10 point-of-care platform.”
The novel biomarker tests complement a wide-range of assays for acute care settings that are already available on sphingotec’s widely used Nexus IB10 point-of-care platform that can be flexibly deployed in laboratory as well as near-patient settings such as emergency departments and intensive care units.
References:
(1) Varga et al (2020): Endothelial cell infection and endothelitis in COVID-19, DOI:https://doi.org/10.1016/S0140-6736(20)30937-5
(2) Mebazaa et al (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study, Crit Care, doi: 10.1186/s13054-018-2243-2
(3) Zhou et at (2020): Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Doi: doi.org/10.1016/S0140-6736(20)30566-3
(4) Takagi (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure, doi: 10.1002/ejhf.1600
(5) Deniau (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure, doi: 10.1002/ejhf.1601
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 cardiac depression. 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 established and commonly used tests for acute and critical care.
About bio-ADM®
sphingotest® bio-ADM® measures blood levels of bioactive adrenomedullin (bio-ADM®), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes.
About DPP3
IB10 sphingotest® DPP3 is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Dipeptidyl peptidase 3 an active enzyme which, when released into the blood, inactivates angiotensin II, a hormone that is important for the heart function. This inactivation leads to hemodynamic instability and consequently cardiac depression. The DPP3 release is a newly identified disease mechanism explaining short-term organ failure in critically ill patients. Early identification of DPP3 release may allow better patient stratification and earlier therapy escalation to improve outcomes.
About penKid®
sphingotest® penKid® measures proenkephalin (penKid®), a stable fragment of the kidney stimulating hormone enkephalin. penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate, the gold standard to assess renal function. Measuring penKid® blood concentrations allows for timely information on kidney function in critically ill patients. Early assessment of worsening and improving of renal function on intensive care units and in emergency departments allows adjustment of nephrotoxic drug administration and the initiation of kidney-protective strategies to prevent acute kidney injury and thereby improve outcomes.
Contact
SphingoTec GmbH
Ruxandra Lenz
Sr. Manager Marketing and Communications
Neuendorfstr. 15 A
16761 Hennigsdorf
Germany
Tel. +49-3302-20565-0
press@sphingotec.de
www.sphingotec.com
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