Hennigsdorf/Berlin, Germany, February 19, 2019 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf Germany) today announced the publication of two studies demonstrating that its kidney function biomarker Proenkephalin (penKid®) is the most accurate surrogate for assessing true glomerular filtration rate (true GFR) and is reliably predictive for acute kidney injury (AKI) in patients with severe burns. Although AKI is a major complication in critically ill patients, current diagnostic standard methods do not properly and timely diagnose impaired renal function. The two recently published studies add to the rapidly growing body of evidence suggesting that penKid® can address this highly unmet diagnostic need.
In Shock (1), a team headed by Prof. Peter Pickkers from Radboud UMC (Nijmegen, The Netherlands) confirmed by in-depth diagnostic method comparison in patients with impaired kidney function that penKid® levels properly reflect kidney function. While today's standard of care uses estimations of the glomerular filtration rate (eGFR) to assess renal impairment, the current study shows that these methods overestimate true GFR with over 30%. The published findings demonstrate that penKid® can add value by properly reflecting true GFR that can otherwise only be measured using in vivo clearance of iohexol, an invasive method too laborious and time-consuming for clinical routine use.
Another study published in the Journal of Burns (2) reports for the first time that high penKid® plasma levels at admission to the intensive care unit (ICU) were associated with the risk for developing AKI in patients with severe burns, where mortality rates range from 30-70%.
The new data suggest, that the current renal function- and AKI standard markers should be complemented with penKid® values for accurately quantifying the kidney function in critically ill patients. Dr. Andreas Bergmann, CEO of sphingotec, commented: "penKid® is an early renal function biomarker that is not biased by co-morbidities while reflecting true GFR. penKid® has been tested for the first time to identify ICU patients with severe burns that need rapid and aggressive intervention to prevent mortality caused by AKI."
To support timely treatment decisions that are likely to improve patient management in critical care patients, sphingotec launched a fully automated CE-IVD-marked penKid® assay on its Nexus IB10 platform in January 2020. This new test complements a wide-range of assays for acute care settings that are already available on this widely used point-of-care platform that can be flexibly deployed in near-patient as well as laboratory settings.