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
• 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
• Boditech Med and SphingoTec announce the launch of the AFIAS sphingotest® penKid® assay, a diagnostic tool designed to aid in kidney function assessment for critically ill patients. • The IVDR-marked assay provides quantitative measurements of Proenkephalin A 119-159 (penKid), supporting clinical decision-making in acute and critical care. • This launch follows a licensing agreement granting Boditech the rights to develop and commercialize penKid-based assays, as well as a market development agreement between the two companies. Gangwon-do, Republic of Korea, and Hennigsdorf/Berlin, Germany, May 6, 2025 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced the commercial launch of the AFIAS sphingotest® penKid® assay. The assay is designed to provide clinicians with a tool for assessing kidney function in critically ill patients by measuring Proenkephalin A 119-159 (penKid), a biomarker that reflects real-time kidney function independently of inflammation or comorbidities. The AFIAS sphingotest® penKid® assay is IVDR-marked for its intended use as an automated fluorescence immunoassay for the in vitro diagnostic quantitative determination of Proenkephalin A 119-159 in human whole blood/plasma, serving as an aid in the diagnosis of acute kidney injury (AKI) in adult patients with sepsis or septic shock. It provides additional information to support clinical decision-making in managing critically ill patients at risk of acute kidney injury (AKI). This launch is the result of a strategic collaboration between Boditech and SphingoTec, including a licensing agreement granting Boditech the rights to develop and commercialize penKid-based assays on its diagnostic platforms, as well as a market development agreement aimed at accelerating global commercialization efforts. Eui-Yul Choi, CEO of Boditech Med, commented: “We are proud to introduce the AFIAS sphingotest® penKid® assay to clinicians worldwide. This launch reflects our commitment to delivering innovative diagnostic solutions that address critical needs in healthcare. Our collaboration with SphingoTec has been instrumental in bringing this important tool to market.” Deborah Bergmann, CEO of SphingoTec, added: “The launch of AFIAS sphingotest® penKid® demonstrates how partnerships can drive innovation and improve access to advanced diagnostics. By combining our biomarker expertise with Boditech’s diagnostic capabilities, we are reaching a new chapter in our collaboration. We are streamlining our processes to support the business of our license partners and further expand our global reach. This enables us to provide clinicians with essential tools to enhance patient care.” Scientific insights on penKid PenKid is a biomarker that enables real-time assessment of kidney function (1). Unlike traditional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex (1,2,3). Studies have shown that penKid allows earlier detection of acute kidney injury (AKI), predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met (1,3). This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock (1,3,4). Additionally, penKid has shown potential for monitoring renal recovery under dialysis and could help predict successful weaning from renal replacement therapy (5,6). ## References 1. 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 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006. 2. Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006 3. Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) DOI:10.1373/clinchem.2018.288068 4. Moledina DG. Penkid: A Novel Biomarker of Reduced GFR in Sepsis. Kidney Int Rep. 2018 Nov 15;4(1):17-19. doi: 10.1016/j.ekir.2018.11.002. 5. von Groote T et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). doi.org/10.1186/s13054-022-04217-4 6. von Groote T, et al. Evaluation of Proenkephalin A 119-159 for liberation from renal replacement therapy: an external, multicenter pilot study in critically ill patients with acute kidney injury. Crit Care. 2023 Jul 10;27(1):276. doi: 10.1186/s13054-023-04556-w. About Boditech Boditech Med (based in Chuncheon, Gangwon-do, Republic of Korea) is a leading company in the field of point-of-care diagnostics, which has accumulated 25 years of business expertise in the field. The company has more than 80 types of in vitro diagnostic products that detect biomarkers related to infectious diseases, diabetes, cardiovascular diseases, cancer, and hormone-related diseases with its immunofluorescence lateral flow technology, quantitative immunofluorescence technology and spectrophotometric technology. And the list continues to grow with new high-value-added products. With its instrument platform installed in more than 120 countries, the company also has a stable revenue model. The company is currently strengthening its value as a global company by expanding its manufacturing bases in the US, China, India, and Indonesia. About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a diagnostic company focusing on the out-licensing of innovative critical care biomarkers 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 Head of Marketing and Communication SphingoTec GmbH Phone +49-3302-20565-0 Email: press@sphingotec.com