sphingotec is adding an advanced POC testing platform to portfolio
- SphingoTec GmbH will offer its next-generation sepsis, heart failure and acute kidney injury biomarkers penKid® and bio-ADM® on NEXUS IB 10 point-of-care (POC) testing platform, originally developed by Nexus Dx
- penKid® and bio-ADM® are first-in-class biomarkers to diagnose and monitor real-time kidney function and endothelial dysfunction which lead to shock in sepsis and congestion in acute heart failure
- POC testing of penKid® and bio-ADM® is set to add significant clinical benefit to emergency departments and intensive care units allowing on-site diagnosis, monitoring, and guidance in therapies of sepsis, decongestion in heart failure and acute kidney injury, thereby improving outcomes in acute heart failure, sepsis and other acute settings.
May 22, 2018 – Hennigsdorf/San Diego
– German diagnostics company SphingoTec GmbH (Hennigsdorf) and Nexus Dx (San Diego) have combined their technology platforms to market sphingotec’s CE-marked acute biomarkers penKid® and bio-ADM® on Nexus’ market-validated POC testing immunoassay platform IB10 to substantially improve decision-making in emergency departments (EDs) and intensive care units (ICUs).
This merger of technologies under the jointly owned holding company Polaris MediNet, LLC. allows emergency physicians for the first time to predict and monitor septic shock, monitor kidney function in acute settings and to monitor and diagnose congestion, including residual congestion – the major reason for re-hospitalization and post-discharge mortality in acute heart failure (AHF) – in emergency departments within a few minutes from whole blood without any sample preparation.
Each year, 8 million people die from sepsis, 700,000 thereof by acute kidney injury (AKI). Sepsis causes $24 billion in direct annual costs for the U.S. healthcare system while acute heart failure’s annual cost of $31 billion is expected to double by 2030. Details of the transaction are subject to confidentiality.
The capability of bio-ADM® to predict circulatory shock in sepsis patients and to predict and monitor residual, diuretic-resistant congestion has been clinically proven by sphingotec in clinical studies with over 20,000 Asian and Caucasian patients[1][2][3]. Furthermore, the functional kidney marker, penKid®, has been shown to predict, diagnose and monitor kidney dysfunction [4][5][6]. penKid® is a real-time surrogate marker for true (actual) kidney function (true GFR) allowing emergency physicians to timely monitor real-time kidney function in acute settings.
The Nexus IB10 POC platform is an easy-to-handle POC system, allowing the detection of biomarkers from whole blood with accuracy and precision. Thus, it is a great tool to bring valuable biomarkers to the physicians in ED and ICU.
“We are delighted to shortly start European distribution of our acute care biomarkers for therapy monitoring and adjustment on a great POC testing platform,” said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH.
“The addition of sphingotec’s next-generation biomarkers to the IB10 platform will allow the timely introduction of a complete solution for the hospital acute point of care market in AKI, AHF and sepsis diagnosis and monitoring,” said Nam Shin, CEO of Nexus Dx Inc.
[1] Caironi et. al (2017) Circulating Biologically Active Adrenomedullin (bio-ADM) Predicts Hemodynamic Support Requirement and Mortality During Sepsis
[2] Marino et al. (2014) Plasma adrenomedullin is associated with short term mortality
[3] Kremer et al. (2017) bio-ADM: a novel marker of congestion in patients with acute heart failure
[4] Beunders et al. (2017) Proenkephalin (PENK) as a Novel Biomarker for Kidney Function
[5] Siong Chan et al. (2018) Proenkephalin in Heart Failure
[6] Ng et al. (2017) Proenkephalin, Renal Dysfunction, and Prognosis in Patients with Acute Heart Failure
About SphingoTec GmbH:
SphingoTec GmbH develops innovative biomarkers for diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, acute kidney injury and circulatory shock, in order to support patient management and provide guidance for treatment strategies. Furthermore, sphingotec develops biomarkers for the risk prediction of common diseases, such as obesity, cardiovascular diseases and breast cancer, in order to support prevention strategies.
About Nexus Dx Inc.:
Nexus Dx, is a global provider of Near Patient Testing systems and advanced diagnostic solutions. 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 $160 million to develop and market the IB10 analyzer system, a disc-based microfluidic immunoassay platform in which a rotating disk automatically separates plasma from whole blood for further analyses. Results of POC testing of troponin I, a cardiac Tnl/CK-MB/Myoglobin panel, NT-proBNP, NT-proBNP/Troponin I and a D-dimer Test are available within 20 minutes.
About Polaris MediNet, LLC: Polaris MediNet (San-Diego) is a holding company jointly owned by Nam Shin, CEO of Nexus Dx and SphingoTec GmbH.
About penKid®:
penKid® is the very first functional kidney marker that works in plasma, is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR) and penKid® indicates two days earlier than the gold standard serum creatinine in patients developing acute kidney injury (AKI). These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function in critically ill patients. In congestive heart failure, penKid® allows to adjust diuretics dosage to the situation in individual patients.
About bio-ADM®:
As a marker of acute vascular dysfunction, bio-ADM® enables both prediction 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.
biomarker-assisted diuretics therapy in patients with congestive heart failure/cardio-renal syndrome, by simultaneous measurement of bio-ADM® and penKid®, targets lower re-hospitalization and mortality rates. Since 2017, sphingotest®bio-ADM® and sphingotest®penKid® immunoassays are distributed in Germany and Austria by bestbion Dx and marketed in China under an agreement with Shuwen Biotech Co. Ltd.
About congestive heart failure:
About 26 million people globally suffer from congestive heart failure. The characteristic loss of pump function of the heart triggers cardiac remodeling – the heart gets stiffer, fibrotic, and cannot pump enough blood into the circulatory system. The lower pump efficacy causes lower oxygen saturation and results in congestion, which means that blood returning to the heart through the veins backs up, resulting in higher venous pressure and causing fluids to build up in the tissues (edema). About 80% of patients with congestive heart failure are also at risk to develop edema, because their microvasculature becomes leaky due to venous hypertension. Physicians try to prevent the worst case – deadly lung edemas – by administration of loop diuretics, which can reduce hypertension by increasing water excretion. However, not all patients fully respond to diuretics. Incomplete response to diuretics therapy is the most common cause of re-hospitalization and post discharge mortality in patients with congestive heart failure. It’s not yet fully understood why patients with congestive heart failure often experience acute kidney injury (AKI). However, there is growing evidence that AKI can be attributed to congestion („cardio-renal syndrome“) and that, vice versa, AKI can trigger heart problems. Management of fluid balance with loop diuretics is challenging – if too much fluid is excreted from tissues, this will support development of AKI. On the other hand, if too little fluid is excreted, lung edemas could return. Besides that, a large proportion of patients with congestive heart failure does not fully respond to diuretics treatment, leading to undetected residual congestion. To date, physicians have no means to identify these patient group at discharge, resulting in high re-hospitalization and post-discharge mortality rates.
Septic shock is defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) < 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician’s assessment of inadequate hemodynamic results.
A new peer-reviewed study in Physiological Reports is the first to evaluate Proenkephalin A 119-159 (penKid) for kidney functional reserve (KFR) assessment, a stress test designed to reveal loss of kidney capacity that may not be apparent from routine blood tests. Within that method, penKid stood out: its dynamic had a far wider range after a protein stimulus than cystatin C (44.2% vs. 10.5% median fractional change) while reaching its maximal response within approx. two hours after protein stimulation. The results extend the published evidence for penKid beyond acute kidney injury into a potential complementary application: assessing kidney functional reserve. Hennigsdorf, Germany – October 6, 2026 – penKid has been evaluated for the first time as a marker of kidney functional reserve (KFR): a new study in Physiological Reports (1) found that its response spanned a much wider range than cystatin C and creatinine clearance after a protein stimulus. The study in 62 participants marks the first published evaluation of penKid for this use. Clinical context and unmet need Kidney function may appear normal on a standard blood test until a large portion of capacity has already gone. Kidney functional reserve testing addresses this gap by measuring how much a kidney's filtration rate can still rise in response to a stimulus, most commonly a protein meal. Once that reserve narrows, the kidney has less room to compensate for future stress such as major surgeries. The study authors note that reserve testing is rarely used in clinical practice, largely because the reference method used, creatinine clearance, is cumbersome, requiring blood and urine collection, can be difficult to perform outside specialized settings, and is affected by processes in the kidney unrelated to filtration itself. Study design and key findings Researchers at the University of New South Wales and Prince of Wales Hospital in Sydney conducted the study in 62 participants: 40 patients having heart surgery, and 22 healthy people, including volunteers, kidney donors, and patients who had a kidney auto-transplant. Participants drank a protein shake, followed by hourly collection of blood samples over a five hour-period. Urine samples were also collected for creatinine clearance testing. After a high protein intake, kidney filtration increases for a few hours: this "extra work" is what the methods were designed to measure. PenKid showed the largest dynamic response, with a median fractional increase of 44% from baseline compared with 30% for creatinine clearance and only about 10% for cystatin C. Unlike creatinine clearance, penKid differentiated healthy participants from cardiac surgery patients, who had a lower KFR. The study also found penKid measurements to be more homogeneous than creatinine clearance measurements, indicating greater consistency across assessments. PenKid was also fast, reaching its peak functional response in about two hours, similar in timing to a two-hour diabetes test (oral glucose tolerance test). Implications for clinical practice Beyond its wider dynamic range, the authors highlight practical advantages specific to penKid-based functional reserve testing: no urine collection is needed, minimal fasting is required, and penKid enables near real-time assessment of kidney functional reserve from blood samples alone. These features suggest penKid may offer a fast and simple alternative to assess how much reserve an individual patient has. "PenKid gave us a fast, consistent read on how much filtration capacity a kidney still has in reserve," said Prof. Zoltan H. Endre, corresponding author of the study, Department of Nephrology, Prince of Wales Hospital, and School of Clinical Medicine, University of New South Wales, Sydney. "A signal that's clear, captured that quickly, turns a kidney stress test from a research tool into something a clinic could actually use." About penKid, scientific insights PenKid is a biomarker for real-time assessment of kidney function. Unlike creatinine, penKid levels are not influenced by inflammation or factors such as age or sex, and prior studies show penKid can detect acute kidney injury (AKI) up to 48 hours before conventional criteria are met (2,3). The new Physiological Reports study provides data for another, complementary application: measuring kidney functional reserve to identify subclinical kidney disease. 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) Rodrigues, C. E. et. al. (2026). Plasma proenkephalin-a facilitates measurement of human kidney functional reserve: From healthy kidney donors to polymorbid patients. Physiological Reports, 14, e71083. https://doi.org/10.14814/phy2.71083 . (2) Caironi P, et al. (2018) Circulating Proenkephalin, Acute Kidney Injury, and Its Improvement in Patients with Severe Sepsis or Shock.; https://doi.org/10.1373/clinchem.2018.288068 (3) Rosenqvist M, et. al. (2019) Proenkephalin a 119-159 (penKid) - a novel biomarker for acute kidney injury in sepsis: an observational study. BMC Emerg Med, doi: 10.1186/s12873-019-0283-9. Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
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