SphingoTec to Present Novel Acute Care Biomarkers and Point-of-Care Diagnostic Solutions at Medica 2019
Hennigsdorf, Germany, November 15, 2019
- SphingoTec GmbH (“sphingotec”) today announced that latest advancements in the development of its portfolio of novel biomarkers and diagnostic solutions will be showcased at Medica 2019 in Düsseldorf, Germany. To improve the management of critically ill patients in acute care settings through timely diagnostic, sphingotec has started making available novel biomarkers that complement a broad menu of existing standard of care tests on its Nexus IB10 point-of-care platform.
Sepsis, septic shock, and acute failure of vital organs such as heart and kidney, are diagnostically underserved medical conditions in critical care settings. Based on a deep understanding of the disease biology, sphingotec has developed novel biomarkers to tackle these unmet needs through diagnostic solutions that allow early identification and monitoring of critically ill patients. sphingotec’s near-term pipeline of novel assays on the Nexus IB10 platform includes:
IB10 sphingotest® DPP3 launched in August 2019 is the first CE-IVD point-of-care biomarker test able to quantify DPP3 blood-plasma levels, a novel and unique biomarker for assessing cardio-renal pathway disruptions leading to short-term organ dysfunction 1, 2. DPP3 is at the core of a novel disease mechanism that has a causal role in cardiac and renal dysfunction.
IB10 sphingotest® penKid®, to be launched in early 2020 as a CE-IVD test, is the first point-of-care assay for Proenkephalin, a unique and proprietary biomarker for real-time assessment of kidney function. Previous studies on more than 30,000 critically ill patients admitted to emergency departments (EDs) or intensive care units (ICUs) with congestive heart failure 3 or sepsis 4 demonstrated that Proenkephalin levels change dynamically with the actual kidney function independently from comorbidities or inflammation 5. The biomarker allows monitoring of renal function in real-time and facilitates earlier detection and more precise monitoring of acute kidney injury than the current standard-of-care.
IB10 sphingotest® bio-ADM® to be launched in mid-2020, is a first point-of-care assay for bioactive Adrenomedullin, a unique biomarker for real-time assessment of endothelial function [6]. Data from more than 20,000 patients confirm that measuring bio-ADM® levels adds value to clinical decision making in ICUs and EDs. Increased blood levels of bioactive Adrenomedullin have been demonstrated to precede endothelial dysfunction, vascular leakage subsequent systemic vasodilation and shock in sepsis 7. Furthermore, it has been shown that elevated levels of bioactive Adrenomedullin indicate the loss of endothelial function leading to congestion in heart failure [8]. IB10 sphingotest® bio-ADM® not only supports earlier clinical interventions but also the monitoring of treatment success.
The Nexus IB10 point-of-care technology provides test results on whole blood sample in only 20 minutes and can be flexibly deployed in emergency departments, intensive care units, and any laboratory setting. In addition to the increasing menu of assays for proprietary biomarkers, the platform features a broad menu of 8 rapid tests for acute care settings including parameters such as the Troponin-I, NT-proBNP, and D-Dimer. Following the acquisition of Nexus Dx Inc., San Diego, USA, in 2018 from the Korean manufacturer Samsung, sphingotec markets the Nexus IB10 point-of-care platform through its continuously expanding distribution network.
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Visit sphingotec at Medica 2019
sphingotec showcases its Nexus IB10 instrument and test portfolio as well as its proprietary biomarkers for acute care conditions at Medica 2019 and welcomes healthcare professionals as well as distributors and diagnostics and pharmaceutical industry representatives interested in partnering at its booth G52 in hall 3.
References
[1] Takagi et. al. (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure
[2] Deniau et. al. (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure
[3] Siong Chan (2018) Proenkephalin in heart failure
[4] Hollinger et. al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Press Release Kidney in Sepsis and Septic Shock (Kid-SSS) Study
[5] Beunders et. al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.
[6] Geven et. al. (2018) Geven 2018 Vascular effects of adrenomedullin and the anti-adrenomedullin antibody Adrecizumab in sepsis
[7] 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
[8] ter Maaten et. al.(2019) Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure
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About sphingotec
SphingoTec GmbH (“sphingotec”; Hennigsdorf by 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 acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec’s assay portfolio includes sphingotest® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of vascular integrity in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signaling pathway disruptions leading to acute organ dysfunction. Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a standard marker portfolio for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.
• 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