SphingoTec launches IVD Test for Kidney Function Biomarker penKid® on Nexus IB10 POCT Platform
- sphingotec launches a CE-marked point-of-care IVD assay for Proenkephalin (penKid®), the company‘s proprietary biomarker for real-time assessment of kidney function in critical care settings
- IB10 sphingotest® penKid® runs on sphingotec's automated Nexus IB10 point-of-care platform and quantitatively measures levels of penKid® directly in whole blood samples
- penKid® is a functional kidney biomarker reflecting the actual glomerular filtration rate and thus allows monitoring of renal function in real-time
- penKid® enables earlier prediction and more precise monitoring of acute kidney injury than the current standard-of-care
Hennigsdorf/Berlin, Germany, January 13, 2020
- Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf near Berlin, Germany) today announced the launch of its IB10 sphingotest® penKid®, a CE-IVD-marked point-of-care test for Proenkephalin (penKid®), the biomarker that allows real-time assessment of kidney function with a simple blood test. The test is made available on the company’s rapid point-of-care platform Nexus IB10 that uses whole blood samples without any pre-processing, requires less than three minutes hands-on-time, delivers test results after 20 minutes and can be flexibly deployed in laboratories or near-patient settings such as intensive care units (ICUs) and Emergency Departments (EDs).
In studies on more than 30,000 patients admitted to ICUs and EDs, penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate[1], the gold standard to assess kidney function. In contrast to other markers, penKid® is an early predictor of worsening and improving kidney function independently from co-morbidities and inflammation[2,3].
penKid® as a functional kidney biomarker has been demonstrated to provide significant clinical utility in numerous critical care settings:
– penKid® blood levels at admission to ICUs and EDs can identify patients at a high risk to develop acute kidney injury (AKI) as elevated blood levels of penKid® indicate kidney dysfunction in critically ill patients much earlier than the current standard of care4.
– penKid® blood levels during hospitalization can be used for real-time monitoring of kidney function. In critical care conditions (such as sepsis, acute heart failure) or after the administration of nephrotoxic drugs, which trigger kidney damage, elevated blood levels of penKid® reflect compromised kidney function. The normalization of kidney function is rapidly mirrored by decreasing levels of penKid®. Hence, penKid® allows for individualized dosing of medicines with nephrotoxic side-effects.
– penKid® blood levels at discharge identify patients who have low levels of this biomarker that can be safely discharged from the hospital while elevated biomarker levels identify patients with sublinical AKI5 that require further attention.
Worldwide AKI is affecting 13 million patients and puts other 26 million at risk. In the ICUs, 1 out of 3 patients will develop AKI6.
Dr. Andreas Bergmann, CEO and founder of sphingotec commented: "Testing and monitoring of blood levels of Proenkephalin with our IB10 sphingotest® penKid® allows not only for the stratification of patients at risk for acute kidney injury at admission to the hospital but also facilitates the monitoring of kidney function in real-time throughout the entire patient care cycle. We strongly believe that making penKid® testing available on a rapid point-of-care platform has a unique potential to enable timely therapy decision by physicians at ICUs and EDs and thereby improve patient outcomes.”
The IB10 sphingotest® penKid® will be made available at the end of January 2020 to the critical care community for further clinical evaluation. The assay is commercialized in Europe and other regions that accept CE-IVD certification through sphingotec’s network of distribution partners for the Nexus IB10 platform, together with a broad menu of standard tests for acute and critical care.
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References
1. Donato L. et al., (2018): Analytical performance of an immunoassay to measure proenkephalin, Clin Biochem., doi: 10.1016/j.clinbiochem.2018.05.010
2. Emmens JE et al. (2019): Proenkephalin, an opoid system surrogate marker, as a novel comprehensive renal marker in heart failure, Circ. Haeart Fail., doi: 10.1161/CIRCHEARTFAILURE.118.005544
3. Gayat E. et al, (2018) Back-to-back comparison of penKID with NephroCheck® to predict acute kidney injury at admission in intensive care unit, Critical Care, doi: 10.1186/s13054-018-1945-9
4. Caironi P. et al. (2018): Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock, Clin.Chem., doi 10.1373/clinchem.2018.288068
5. Rosenqvist, M. (2019): Proenkephalin A 119–159 (penKid) – a novel biomarker for acute kidney injury in sepsis: an observational study, doi: 10.1186/s12873-019-0283-9
6. Ponce, D. (2016): Acute kidney injury: risk factors and management challenges in developing countries, Int J Nephrol Renovasc Dis., doi: 10.2147/IJNRD.S104209
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, and Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function. An IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function is expected to be launched by mid-2020.
About penKid®
sphingotec’s proprietary biomarker Proenkephalin (penKid®) is a functional kidney biomarker that works in whole blood, is independent from comorbidities and inflammation and provides timely information about changes in kidney function. penKid® is a surrogate marker for the gold standard of glomerular filtration rate (GFR) and indicates two days earlier than the standard-of-care the development of acute kidney injury (AKI) in critically ill patients. These features enable physicians to predict, diagnose, and closely monitor worsening and improving kidney function in emergency departments and intensive care units.
• 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