Boditech Med and SphingoTec Announce Launch of AFIAS penKid® Assay for Kidney Function Diagnostics

• Real-World Implementation: Proenkephalin A 119–159 (penKid) has been successfully integrated into daily practice in intensive care unit (ICU), demonstrating its effectiveness in assessing kidney function and predicting acute kidney injury (AKI) in over 4,000 patients. • Superior Dynamics: PenKid augments traditional markers by detecting rapid changes in kidney function, particularly beneficial in critically ill patients where timely information is crucial. • Clinical Impact: PenKid proved valuable in identifying high-risk patients at ICU admission, especially those with a normal serum creatinine. Additionally, penKid provided valuable insights into kidney function during renal replacement therapy (RRT). • International Recognition: Beyond its use in reference hospitals in Germany, international experts, including those at the Mayo Clinic, acknowledge the added value of penKid on top of standard care. Hennigsdorf/Berlin, Germany, April 16, 2025 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces the publication of real-world data on the effectiveness of Proenkephalin A 119–159 (penKid) in improving kidney function assessment in intensive care units (ICUs) (1). This study confirms penKid's value in identifying high-risk patients at admission and supporting the management of renal replacement therapy (1). The published data complement a recent review from the Mayo Clinic that highlights penKid's potential as a new method to measure renal function beyond creatinine (2). Acute kidney injury (AKI) is a significant challenge in intensive care units (ICUs), affecting up to half of all patients and leading to increased morbidity and mortality (1). Traditional markers like serum creatinine have limitations, as they may not detect kidney dysfunction until significant damage has occurred. A recent study from the University Hospital Aachen marks the first publication based on real-world data from over 4,000 patients, reporting the outcome implementation of penKid in daily practice. Study Overview During a two-year period, the University Hospital Aachen, Germany implemented penKid in their ICU (1). The study analyzed almost 18,000 penKid measurements from 4,169 patients, including the use of a penKid-GFR formula to estimate glomerular filtration rate (GFR). PenKid outperformed traditional markers in assessing kidney function and remained dynamic under RRT, supporting clinical decision-making in critical care. Key Findings The data show that penKid allows for a significantly better assessment of renal dysfunction upon admission, particularly in identifying patients at risk of developing severe AKI. In patients with normal serum creatinine levels at admission, penKid and its GFR formula outperformed traditional methods in predicting AKI within 24 and 48 hours. As penKid is effectively removed by RRT, as demonstrated by studies such as Lorenzin et al. (3), persistently elevated levels during RRT may indicate ongoing renal dysfunction, while declining levels could signal renal recovery. This dynamic nature of penKid – even during ongoing RRT - can support decisions that may optimize RRT duration and reduce associated risks. Clinical Significance Prof. Dr. Gernot Marx, the Director of the Clinic for Operative Intensive Care and Intermediate Care at Uniklinik RWTH Aachen highlights, "After using penKid in clinical settings for five years, I see significant value in specific use cases due to its swift dynamics, addressing creatinine blind spots. The published data confirms our clinical observations and paves the way for bringing innovation into daily practice." Early detection of compromised renal function could allow for timely interventions, reducing the risk of emergency RRT and improving the chance for full renal recovery. In RRT scenarios, penKid could help de-escalate treatments and prevent unnecessary RRT, potentially reducing ICU stays. Recent Review The critical care community is seeking tools for improving kidney health assessment, as indicated by a recent review published by researchers from the Mayo Clinic (2). This review highlights penKid's ability in detecting rapid GFR changes and predicting AKI, particularly in critically ill patients. PenKid's strong correlation with measured GFR makes it a valuable tool, enabling more accurate and timely assessments of kidney function. The Mayo Clinic review also notes that penKid's ability to predict major adverse kidney events, such as worsening renal function and the need for RRT, aligns with its potential to provide valuable prognostic information in clinical settings. ## References 1. Martin, L. et al. Implementation and One-Year Evaluation of Proenkephalin A in Critical Care. Int. J. Mol. Sci. 2025, 26, 2602. https://doi.org/10.3390/ijms26062602 2. Sheikh MS, Kashani KB. Beyond creatinine: New methods to measure renal function? Eur J Intern Med. 2025 Jan 31:S0953-6205(25)00025-1. doi: 10.1016/j.ejim.2025.01.015. 3. Lorenzin, A. et al. Human Proenkephalin A 119-159 (penKid) in Extracorporeal Therapies: Ex vivo Sieving Coefficient, Diffusive Clearance, and Hemoadsorption Kinetics. Blood Purif. 2024, 53, 773–780. doi: 10.1159/000540061. 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