sphingotec and bestbion dx partner to market predictive biomarkers for guidance of therapy in acute heart failure and septic shock
Hennigsdorf-Berlin/Cologne 14. May 2017
German diagnostics company SphingoTec GmbH (Hennigsdorf) and bestbion dx GmbH (Cologne) have signed an agreement to market sphingotec’s innovative sepsis and congestive heart failure test (sphingotest® bio-ADM) and acute kidney function monitoring assay (sphingotest® penKid). Under the agreement, bestbion dx will market both biomarker assays, set to improve therapy monitoring and outcomes in intensive care units and emergency departments, in Germany and Austria.
bio-ADM is a biomarker for vascular dysfunction, which allows to predict septic shock and thus can guide treatment choices. In congestive heart failure, bio-ADM is the first biomarker that identifies patients having (residual) edema and patients at high risk to develop life-threating residual (i.e. lung) edemas, caused by incomplete response or therapy resistance to decongestion therapy with loop diuretics. 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 acute kidney failure (AKI), which frequently occurs in congestive heart failure patients receiving diuretics. Monitoring of congestive heart failure patients, who receive diuretics, with both, bio-ADM and penKid, thus allows physicians to prevent AKI while excluding incomplete decongestion.
sphingotest® penKid and sphingotest® bio-ADM complement bestbion dx’s portfolio of marketed assays in the area of congestive heart failure. The company already markets an assay for ST2, an innovative biomarker that detects cardiac remodeling early on and opens the avenue to early intervention and an optimized adjustment of congestive heart failure therapies.
„We are delighted that bestbion dx will distribute our acute care biomarker assays for therapy monitoring and adjustment“, said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH. „Our biomarker assays support physicians with information to monitor and adjust the diuretics therapy to the need of each individual patient suffering from congestion“.
„sphingotec’s tests complement our portfolio of marketed biomarker assays to monitor congestive heart failure“, said Werner Dummert, Sales Director of bestbion dx. „ penKid, bio-ADM and ST2 are a dream team for physicians, as they can contribute to significant improvements in the adjustment of beta-blocker and diuretics dosage in congestive heart failure and associated acute kidney injury. The collaboration with sphingotec perfectly reflects bestbion dx’s mission statement „Rescue and sustain lives“.
About congestive heart failure:
About 1.8 million Germans and 250.000-300.000 Austrians 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 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.
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.
A biomarker-assisted diuretics therapy in patients with congestive heart failure, by simultaneous monitoring of bio-ADM and penKid levels, promises lower re-hospitalization and mortality rates.
About ST2:
ST2 is a fibrosis marker rapidly indicating cardiac remodeling. It can be used for prognosis and therapy monitoring and dosage adjustment of beta-blocker therapy in patients with congestive heart failure, which has been shown to reduce mortality and re-hospitalization.
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.
bestbion dx GmbH (Cologne, Germany)
is one of the European-leading distributor of innovative diagnostic and prognostic assays with outstanding track-record in Germany and Austria. The private company was founded in 2011 by Bernd Stammel and focuses on microbiology, infectious diseases, molecular biology, cardiology and point-of-care testing.
• 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