New data on innovative biomarkers used to guide the clinical management of septic patients
- Endothelial and kidney dysfunction are common complications in septic patients leading to organ failure and unfavorable outcomes.
- The organ-specific biomarkers bio-ADM and penKid are used in clinical routine for monitoring the endothelium and respectively kidney function in intensive care units.
- Prof. Dr. Gernot Marx of Uniklinik RWTH Aachen is presenting at ISICEM new evidence on how the use of biomarkers can support clinicians in the management of sepsis.
Aachen, Germany and Hennigsdorf/Berlin, Germany, August 31, 2021
– German University Hospital Uniklinik RWTH Aachen (“Uniklinik RWTH Aachen”) and diagnostics company SphingoTec GmbH (“SphingoTec”) announce today that novel data on the acute care biomarkers bioactive adrenomedullin (bio-ADM) and proenkephalin (penKid) will be presented at the 40th International Symposium on Intensive Care and Emergency Medicine (ISICEM) taking place in Brussels, Belgium on August 31 - September 3, 2021. Sepsis is a medical emergency in need of quick therapeutic decisions, although it often progresses undetected in its early stages and remains difficult to manage in the late stages. The organ specific biomarkers first introduced in the clinical routine at Uniklinik RWTH Aachen, Germany offer a new perspective on the disease pathology and facilitate a more timely and efficient treatment.
Prof. Dr. Gernot Marx, the Director of the Clinic for Operative Intensive Care and Intermediate Care at Uniklinik RWTH Aachen, one of the largest ICU wards in Europe, explains “Septic patients are at high risk of developing life-threatening complications. The use of biomarkers that can facilitate a faster and better diagnosis and monitoring of sepsis progression allows clinicians to provide the best available treatment. I am excited to share with the critical care community the latest insights on improving septic patients’ management with the help of innovative biomarkers.”
PenKid is a biomarker for the real-time assessment of kidney function. It is a blood-based solution for detecting true glomerular filtration rate (true GFR) in clinical routine testing and is independent from inflammation and comorbidities (1). PenKid has been proven to not only predict septic acute kidney injury earlier than today’s standard of care, but also to detect the presence and severity of the disease, identify patients at high risk of unfavorable outcomes and indicate the renal recovery (1,2).
Bio-ADM is a biomarker for the real-time assessment of endothelial function (3). The endothelium is the interior wall of the blood vessels that acts as a barrier separating the blood from its surroundings. Bio-ADM enables the assessment of endothelial function up to 48 hours before the symptoms become visible. High bio-ADM levels indicate severe hypotension, edema formation, need for immediate therapeutic interventions and for organ support. Being a dynamic biomarker, low or decreasing bio-ADM blood levels indicate improved outcomes (3,4).
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40th ISICEM Presentation:
Session: Sepsis Biomarkers
Title: “Endothelial and kidney function biomarkers to guide management”
Speaker: Dr. Gernot Marx, Uniklinik RWTH Aachen, Germany
Date & Time: September 1. at 5:15 p.m. CET
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References
(1) Khorashadi M, et al. Proenkephalin: A New Biomarker for Glomerular Filtration Rate and Acute Kidney Injury. Nephron. 2020;144(12):655-61 DOI: 10.1159/000509352
(2) 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;3(6):1424-33. DOI: 10.1016/j.ekir.2018.08.006
(3) Geven C, et al. Vascular Effects of Adrenomedullin and the Anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. 2018 Aug;50(2):132-140. doi: 10.1097/SHK.0000000000001103.
(4) van Lier D, et al. Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3. J Intern Med. 2021 Jun;289(6):792-806. doi: 10.1111/joim.13220.
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.
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
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