Endothelial Function Biomarker bio-ADM to Support Risk Stratification and Clinical Management of COVID-19 Patients
- Bioactive Adrenomedullin (bio-ADM) is an established biomarker for the real-time assessment of endothelial function in critical care settings
- Endothelial dysfunction plays a central role in the pathophysiology of COVID-19
- Data from the German University Hospital RWTH Aachen show that endothelial function biomarker bio-ADM can support the management of COVID-19 patients
- Elevated bio-ADM levels indicate disease severity and predict the need for extracorporeal organ assist in COVID-19 patients
- SphingoTec has made available to the critical care community a rapid point of care test for measuring bio-ADM levels at the point of need
Aachen, Germany and Hennigsdorf/Berlin, Germany, May 4, 2021
– German University Hospital Uniklinik RWTH Aachen (“Uniklinik RWTH Aachen”) and diagnostics company SphingoTec GmbH (“SphingoTec”) today announced that the endothelial function biomarker bio-ADM aids in the early risk stratification and management of patients suffering from severe COVID-19, in need for escalated intensive care treatment (1). A team lead by the clinical researchers at Uniklinik RWTH Aachen has shown that high bio-ADM levels indicate the severity of the acute respiratory distress syndrome (ARDS), the subsequent need for organ support, and poor outcomes in severely ill COVID-19 patients. Bioactive Adrenomedullin (bio-ADM) is a hormone regulating endothelial function and has been previously validated in over 35.000 patients with diseases where endothelial dysfunction plays a key role, such as sepsis, septic shock, cardiogenic shock, and acute heart failure.
According to the recently published data (1), high bio-ADM levels predict a severe course of COVID-19 infection at admission and identify patients with deteriorating lung function at high risk to develop severe ARDS. Furthermore, the data demonstrate that high bio-ADM levels identify those patients in need of extracorporeal organ assist, such as mechanical ventilation, veno-venous extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT).
Prof. Gernot Marx, (Director of the Department of Operative Intensive Care Medicine and Intermediate Care at Uniklinik RWTH Aachen) commented, “In the management of COVID-19 patients there is a high need for early risk stratification biomarkers that allows us to allocate resources and timely plan for therapy escalation. Endothelial dysfunction is a central mechanism in the pathophysiology of many critical care conditions, including COVID-19. The information provided by the bio-ADM measurements has convinced us to include it in our clinical routine measurements. “
These findings confirm and extend previous studies in critical care patients where bio-ADM indicates severe complications in sepsis (2,3), acute heart failure (4), and cardiogenic shock (5). High bio-ADM levels indicate severe hypotension, edema formation, ionotropic/vasopressor use, need for organ support, such as mechanical ventilation, and subsequent organ failure. Being a dynamic biomarker, low or decreasing bio-ADM blood levels indicate improved outcomes (3).
Dr. Andreas Bergmann, CEO and founder of SphingoTec, said, “By monitoring the endothelial dysfunction early in COVID-19 patients, clinicians can timely identify those patients with an unfavorable disease progression. To further support the management of critically ill patients, we have made available the assay for bioactive Adrenomedullin as a rapid near-patient test.”
The CE marked point of care assay for measuring bio-ADM levels is commercialized under the brand name IB10 sphingotest® bio-ADM®. The rapid test runs on SphingoTec`s automated Nexus IB10 point-of-care platform and quantitatively measures levels of bio-ADM directly in blood samples and delivers results after 20 minutes.
References
(1) Simon T-P et al. Prognostic Value of Bioactive Adrenomedullin in Critically Ill Patients with COVID-19 in Germany: An Observational Cohort Study. Journal of Clinical Medicine.
2021, 10, 1667. doi.org/10.3390/jcm10081667
(2) Mebazaa A et al. 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. Critical care. Dec 21 2018;22(1):354.
(3) Caironi P et al. Circulating Biologically Active Adrenomedullin (bio-ADM) Predicts Hemodynamic Support Requirement and Mortality During Sepsis. Chest. Aug 2017;152(2):312-320.
(4) Ter Maaten JM et al. Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure. European journal of heart failure. Jun 2019;21(6):732-743.
(5) Tolppanen H et al. Adrenomedullin: a marker of impaired hemodynamics, organ dysfunction, and poor prognosis in cardiogenic shock. Annals of intensive care. Dec 2017;7(1):6.
Uniklinik RWTH Aachen
The Uniklinik RWTH Aachen is a supramaximal care provider that combines patient-oriented medicine and nursing, teaching and research at an international level. With 36 specialist clinics, 28 institutes and five interdisciplinary units, the University Hospital covers the entire medical spectrum. Excellently qualified teams of doctors, nurses and scientists are competently committed to the health of the patients. The bundling of patient care, research and teaching in one central building offers the best conditions for intensive interdisciplinary exchange and close clinical and scientific networking. Around 8.000 employees provide patient-oriented medicine and care according to recognized quality standards. With 1.400 beds, the University Hospital treats around 50.000 inpatient and 200.000 outpatient cases per year.
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. 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. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform.SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.
About bio-ADM
IB10 sphingotest® bio-ADM® is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination 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.
Press contact
Dr. Mathias Brandstädter
Leitung Unternehmenskommunikation
Uniklinik RWTH Aachen
Pauwelsstraße 30
52074 Aachen
Telefon: 0241 80-89893
mbrandstaedter@ukaachen.de
www.ukaachen.de
Ruxandra Lenz
Sr. Manager Marketing and Communications
SphingoTec GmbH
Neuendorfstr. 15 A
16761 Hennigsdorf
Germany
Tel. +49-3302-20565-0
press@sphingotec.com
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