sphingotec reveals novel results on bioactive adrenomedullin for diagnosis and therapy monitoring of septic shock at the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM)
sphingotec reveals novel results on bioactive adrenomedullin for diagnosis and therapy monitoring of septic shock at the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM)
- Data from more than 20,000 patients show that bio-ADM® adds value to clinical decision-making at ICUs and EDs because it is the only biomarker that allows early prediction of septic shock
- bio-ADM® allows starting life-saving interventions such as early
- administration of vasopressors which will benefit about 20% of sepsis patients
- bioADM® is used for patient selection in an ongoing phase II trial with therapeutic antibody Adrecizumab
- bio-ADM® POC test for rapid decision-making at ICUs and EDs will be launched by H1/2019
HENNIGSDORF, GERMANY - March 19, 2019
- Diagnostics company SphingoTec GmbH reports novel applications of bio-ADM® (bio-active adrenomedullin), the very first biomarker capable to diagnose the onset of septic shock, allowing physicians earliest life-saving therapeutic interventions in sepsis critical care. At the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM, 19–22 March, 2019, Brussels), Prof Peter Pickkers (Radbound umc Nijmegen, The Netherlands) will report that bio-ADM® is used to select patients at high risk for septic shock for treatment with the antibody Adrecizumab (Adrenomed AG, Hennigsdorf, Germany), which is being evaluated in an ongoing Phase II study on patients with early septic shock.
bio-ADM® is the only biomarker capable of diagnosing endothelial dysfunction, which has been demonstrated to precede the life-threatening blood pressure break down that causes multi-organ failure, shock and death of sepsis patients at intensive care units (ICUs) and in emergency departments (EDs). In studies on more than 20,000 patients, high bio-ADM® plasma levels (>70pg/ml) have been shown to predict the onset of septic shock, 28-day mortality and vasopressor demand independently of co-morbidities or inflammation. Without bio-ADM® testing, norepinephrine administration is initiated about 3.1 ± 2.5 hours after the onset of septic shock [1]. Every 1-hour of treatment delay is associated with a 5.3% increase in mortality. Early identification of patients running into shock will thereby statistically benefit one out of five septic shock patients (20%). As decreasing bio-ADM® levels have been linked to improved outcomes in clinical testing and pilot routine testing, bio-ADM® not only supports early clinical decision making but also monitoring of response to therapeutic intervention.
According to Pickkers, the further utility of bio-ADM® testing is provided by the selection of high-risk patients in clinical trials. Lack of stratification out of the highly heterogeneous sepsis population has been a major cause of failure in more than 60 late-stage trials with potential sepsis therapeutics in the past 20 years. Adrenomed AG is developing an antibody that leads to enrichment of bio-ADM® in the vessel lumen, where the vasoactive peptide hormone restores vascular integrity.
“It’s a great advantage that we are able to improve patient enrichment using sphingotest® bio-ADM® in order to demonstrate the efficacy of Adrecizumab”, commented Dr. Andreas Bergmann founder of both, sphingotec and Adrenomed, and CEO of sphingotec. “However, we should be aware that the diagnostic utility of bio-ADM® goes far beyond patient enrichment, as a single bio-ADM® measurement can exclude or diagnose endothelial dysfunction and thus assist critical care specialists to save lives in patients who most urgently need rapid therapeutic intervention.” Dr.Bergmann is the co-founder of BRAHMS/ThermoFisher Scientific and co-inventor of procalcitonin, a sepsis diagnostic with an annual turnover of $600m. He is currently working to establish fully automated blood POC testing of bio-ADM® as well as establishing an innovative critical care biomarkers on the Nexus IB 10 platform, by summer 2019.
[1] Xiaowu Bai et al., Early vs delayed administration of epinephrine in patients
with septic shock. Critical Care 18: 532
About SphingoTec GmbH:
SphingoTec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bioADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, is additionally developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.
About bio-ADM®:
As a marker of vascular integrity, bio-ADM® enables both predictions of circulatory shock 48 h before blood pressure breakdown, e.g. in septic patients, and diagnosis of diuretic-resistant congestion in acute heart failure patients.
• 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