SphingoTec transforms into end-to-end diagnostic solutions provider and exclusively represents Nexus Dx IB10 immunoassay portfolio
• Following the acquisition and integration of former Samsung subsidiary Nexus Dx Inc., sphingotec becomes a fully integrated diagnostic solutions provider
• Nexus Dx IB10 POC immunoassay platform (formerly branded as Samsung LabgeoIB10) including its entire test portfolio for critical care environments will be marketed through sphingotec’s distributor network
• After introducing the assay for DPP3, a biomarker for short-term organ dysfunction, sphingotec will continue to add novel critical care tests to the IB10 test menu in 2020, including penKid®, a proprietary kidney function biomarker and bio-ADM®, a proprietary endothelial function biomarker
Hennigsdorf, Germany, and San Diego, CA, USA, January 09, 2020
– The German diagnostics company sphingotec GmbH (Hennigsdorf, Germany) today announced that through its network of regional and local distribution partners it will exclusively offer the Nexus Dx IB10 immunoassay platform together with a broad portfolio of commonly used tests for acute and critical care. The biomarker company has also started to launch a series of novel proprietary tests on the Nexus IB10 point-of-care platform to aid in the diagnose and monitor life-threatening conditions such as sepsis, acute kidney injury and heart failure.
Following the acquisition of Nexus Dx from Samsung in 2018, sphingotec has obtained all rights to Nexus Dx’s unique IB10 immunoassay platform for simple and rapid testing of diagnostic parameters for acute and critical care utilized in point-of-care settings such as emergency departments (EDs) and intensive care units (ICUs). Using disposable low-cost reagents discs, the instrument can perform up to three diagnostic parameters on one test disc in only 20 minutes using routinely available whole blood samples. The Nexus IB10 platform, formerly branded Samsung LabgeoIB10, has sold more than 1,800 systems since its introduction in 2012. The IB10 instrument is one of the most commonly used point-of-care immunoassay platforms throughout Europe and beyond. The CE-IVD-marked IB10 analyzer and test portfolio, which was previously commercialized by Samsung’s partner ThermoFisher Scientific, will now be exclusively represented by sphingotec and made available through sphingotec’s global network of distribution partners.
While initially marketed with a broad range of blood tests and test panels routinely used in EDs and ICUs such as tests for Troponin I, NT-proBNP, D-Dimer, sphingotec has begun implementing a series of new CE-IVD-marked assays for its proprietary biomarkers for the diagnosis and monitoring of life-threating acute and critical care conditions. This includes the recently introduced IB10 sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a protein whose elevated blood levels are a major cause for heart and kidney dysfunction in patients with acute heart failure, sepsis and other critical conditions. Further, near-term launches include an IB10 assay for penKid®, a novel biomarker for the real-time assessment of kidney function, and an IB10 assay for bio-ADM®, a biomarker for real-time assessment of endothelial function, planned to be launched in early and mid-2020, respectively.
Using the assays for DPP3, penKid® and bio-ADM® on the IB10 platform, clinicians will have parameters available that provide actionable information needed to aid in the diagnosis and monitoring of critically ill patients and may significantly improve the management of patients with sepsis, septic shock, cardiogenic shock, and organ failure.
“With the integration of Nexus IB10 platform and the set-up of our own distribution-based sales channel, sphingotec has transformed from a developer of unique biomarkers to a fully integrated commercial provider of complete solutions for innovative rapid diagnostic testing at the point-of-need in acute care settings,” said Dr. Andreas Bergmann, CEO of sphingotec GmbH. “Providing rapid and novel solutions needed by clinicians in managing critically ill patients is part of our long-term strategy to reduce mortality in the ICU´s and ED´s.”
sphingotec will ensure continuous supply of IB10 consumables to all former ThermoFisher Scientific customers. Customers can place supply requests through sphingotec’s website at sphingotec.com for referral to the sphingotec IB10 distributor in their respective region.
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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 cardio-renal pathway disruptions leading to acute organ dysfunction. 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 IB10 tests for established biomarkers for acute and critical care.
About Nexus Dx Inc. and the IB10 Platform
Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. The IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function and the assay for Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, will be launched later in 2020.
bio-ADM®
sphingotest® bio-ADM® measures blood levels of bioactive adrenomedullin (bio-ADM®), a hormone maintaining endothelial function. The endothel 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 endothel 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 measures Dipeptidyl peptidase 3 an active enzyme which, when released into the blood, degrades hormones that maintain organ function. Inactivation of such hormones by DPP3 results in organ dysfunction and subsequent death. The DPP3 release is a newly identified pathway explaining most of the deaths in critically ill patients as it is causal for short-term organ dysfunction. Early identification of DPP3 release allows better patient stratification and early interventions 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
PR & Market Communications Manager
Neuendorfstr. 15A
16761 Hennigsdorf
Germany
Tel. +49-3302-20565-34
press@sphingotec.de
www.sphingotec.com
In a prospective, real-world study of 1,436 critically ill ICU patients, proenkephalin A 119–159 (penKid) provided clinically relevant information across AKI severity and during kidney replacement therapy (KRT). PenKid addressed a key unmet need in KRT management by identifying, with greater precision than standard biomarkers, patients at high risk of KRT liberation failure – helping to avoid stopping therapy too early. The findings support a future role for penKid in helping to standardize one of the few intensive care processes where the need for better decision support is widely acknowledged and current tools remain insufficient. Hennigsdorf, Germany – August 27, 2026 – SphingoTec GmbH announces the publication of new real-world data on proenkephalin A 119–159 (penKid) in critically ill patients. The data, published in Annals of Intensive Care, add to the growing body of evidence supporting penKid as a functional biomarker for kidney function and help inform clinical decision-making in AKI and KRT (1). In a prospective observational study at Heidelberg University Hospital, penKid was measured in 1,436 critically ill patients, including 138 patients receiving KRT for liberation analyses. The findings showed that penKid rose with AKI severity and, unlike serum creatinine and urine output, distinguished stage 3 AKI patients with and without an acute KRT requirement. In contrast to serum creatinine, penKid also differentiated acute KRT patients from those with pre-existing kidney failure and on chronic hemodialysis prior ICU admission, even while KRT treatment was ongoing (1). The study further showed that penKid levels increased progressively from the start of KRT, while serum creatinine decreased under treatment. Following successful liberation from KRT, penKid declined, whereas higher levels were seen in cases of liberation failure. In multivariable analysis, penKid was the strongest independent predictor of liberation failure and outperformed serum creatinine. A penKid cut-off of ≥250 pmol/L provided more than 90% specificity for liberation failure (1). By identifying patients at high risk of unsuccessful liberation, penKid may help clinicians make KRT discontinuation decisions more objectively, reduce the risk of stopping therapy too early, and support more standardized decision-making across critical care settings. “These data are important because they address a real-world clinical problem: how to better assess kidney function and support KRT decisions when standard markers fall short,” said Deborah Bergmann, CEO of SphingoTec. “penKid provides clinicians with an objective, real-time measurable parameter that may help support more informed and consistent kidney-related decisions in critical care.” Christian Nusshag, MD, Department of Nephrology, Heidelberg University Hospital, said: “Current markers often leave clinicians with an incomplete picture. Our findings suggest that penKid may help standardize decision-making by providing additional, actionable information on kidney integrity and recovery.” About penKid, scientific insights PenKid is a biomarker that enables real-time assessment of kidney function. Unlike conventional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex. Studies have shown that penKid allows earlier detection of AKI, predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met. This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock. Additionally, penKid has shown potential for monitoring renal recovery under KRT and could help predict successful liberation from KRT. 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 acute heart failure. Discover more on www.sphingotec.com References (1) Gabriel DC, Sauer P, Happel R, et al. Proenkephalin A for Assessing Kidney Integrity and Guiding KRT Liberation Decisions in Critically Ill Patients. Annals of Intensive Care. 2026. DOI: 10.1016/j.aicoj.2026.100113. Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
Hennigsdorf, Germany – August 19, 2026 – Over the coming months, SphingoTec will be present at a series of leading conferences in diagnostics and critical care medicine. These engagements reflect the company’s ongoing commitment to advancing biomarker-driven solutions that support earlier and more precise clinical decision-making in acute and critical care settings. The company’s conference schedule includes: DGAI (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin), September 16-18, 2026, Kassel, Germany Kongress für Nephrologie 2026 (DGFN / Deutsche Gesellschaft für Nephrologie), October 08-11, 2026, Leipzig, Germany ESICM Lives, October 10-14, 2026, Lisbon, Portugal – SphingoTec will co-host a Scientific Symposium together with business partner Boditech, focusing on innovations in sepsis diagnostics. In parallel, new clinical data on penKid in a multicenter sepsis study will be presented as a poster at the ESICM congress. ASN Kidney Week 2026, Denver, CO, USA, October 22–25, 2026 – penKid takes center stage in the poster sessions with the abstract “Proenkephalin Predicts Severe AKI in High-Risk Patients” Medica, November 16-19, 2026, Düsseldorf, Germany – Focus on expanding SphingoTec’s international industry network and advancing partnering opportunities for its biomarker portfolio. DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin), December 2-4, 2026, Hamburg, Germany “These events bring together clinicians, researchers, and industry partners who share our goal of improving outcomes for patients in critical care,” said Deborah Bergmann, CEO of SphingoTec. “By presenting our latest data and engaging in direct dialogue, we aim to strengthen collaborations that translate biomarker innovation into real clinical value.” 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 acute heart failure. Discover more on www.sphingotec.com Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany