sphingotec and Shuwen Biotech partner to market sphingotec´s biomarkers portfolio in China

Hennigsdorf-Berlin  14. August 2017

German diagnostic company SphingoTec GmbH (Hennigsdorf) and Chinese Company Shuwen Biotech Co. Ltd (Deqing) have signed an agreement to market Sphingotec’s biomarkers portfolio in China.

Under the agreement, Shuwen will directly develop and market Sphingotec reliable immunoassays. For acute care, these are the Sphingotest® penKid and Sphingotest® bio-ADM tests, set to improve therapy monitoring and outcomes in intensive care units and emergency departments.

For the “Medicine of the Future” predictive test field, the sphingotest® pro-NT, sphingotest® pro-ENK, sphingotest® vr-hGH and sphingotest® ApoE4 are set to improve prediction and hence timely prevention of life-threatening diseases such as breast cancer, cardiovascular disease and Alzheimer, respectively.

In the acute care field, bio-ADM is a biomarker for vascular dysfunction, oftentimes causing worsening or escalation of conditions in various disease states. For example, bio-ADM predicts septic shock in critically ill patients and thus can guide treatment choices. In congestive heart failure, bio-ADM is the first biomarker that identifies patients having (residual) edema, caused by incomplete response or therapy resistance to decongestion therapy with loop diuretics. Septic shock is the most expensive conditions treated in the US hospital with a mortality rate of up to 80%, while unidentified residual congestion is the major cause for re-hospitalization and post-discharge mortality in congestive heart failure patients causing 30% of deaths and global annual cost of US$39bn.

penKid is a kidney function biomarker predictive for development of acute kidney Injury (AKI), a condition that complicates up to 30% of all hospital admission and that widely increase mortality and length of stay.

„We are delighted that Shuwen will distribute our biomarker portfolio in China“, said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH. „Our patent-protected assays support physicians with information needed to improve patient management in acute settings and in prevention of life-threatening diseases“.

„The introduction of sphingotec tests is a major step forward for the Chinese healthcare system“, said Jay Z. Zhang, CEO of Shuwen Biotech. „Both acute care and disease prevention will vastly benefit from the sphingotec® biomarkers by supporting timely and clear clinical decision making to change patient outcome.

About penKid: penkid is the very first plasma marker to monitor renal function, which 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 is elevated about 24-48 h earlier than the standard marker 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 endothelial dysfunction, bio-ADM enables both prediction of circulatory shock, e.g. in septic patients, and prediction of residual, diuretic resistant congestion in acute heart failure patients. bio-ADM plasma levels below the cut-off value of 70 pg/ml indicate successful diuretic therapy.

About pro-NT & pro-ENK: pro-NT is a strong risk predictor for the development of breast cancer in the next five years. This predictive power can be further enhanced by the measurement of Sphingotest® pro-ENK, which results can be added on top of pro-NT to further quantify the risk of developing breast cancer. In contrast to genetic testing that solely focus on the encoded predisposition to develop breast cancer, pro-NT and pro-ENK values represent the phenotype and show to change following lifestyle adjustments.

About vr-HgH: vr-hGH allows for the assessment of future onset of cardiovascular events in male, such as stroke and myocardial infarction, with a predictive power that largely overshadow the currently known measured parameters like troponin and natriuretic peptides.

About ApoE4: ApoE4 is a reliable and simple method to detect Apolipoprotein 4, a protein that is widely known to be connected to the future onset of Alzhaimer Disease. Sphingotest® ApoE4 is much simpler and cost-effective than the currently used genetic tests.

SphingoTec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock. The company, founded by Dr. Andreas Bergmann in 2002, has also in its portfolio biomarkers which can predicts risks of obesity, breast cancer and cardiovascular diseases.

Shuwen Biotech Co. LTD Based in China and led by U.S. and European diagnostic industry veterans, Shuwen Biotech is engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide China’s doctors and their patients with a comprehensive menu of the most innovative products and services for improved disease prediction, screening, diagnosis, prognosis and treatment in the areas of cancer, maternal fetal medicine, acute care, and preventive testing.
October 5, 2026
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
August 27, 2026
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