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
• 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