SphingoTec's biomarker penKid® shows best representation of true glomerular filtration rate and has utility in patients with sever burns two studies show

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.

In-depth method comparison by Dutch group shows that sphingotec's proprietary kidney function biomarker penKid® is currently the most accurate surrogate marker for true glomerular filtration rate in patients with renal impairment
Data by PRONOBURNS group show that penKid® accurately predicts acute kidney injury (AKI) in patients with burns, adding benefit on top of standard testing
Since January 2020, an automated CE-marked IVD penKid® assay developed for sphingotec's proprietary point-of-care platform Nexus IB10 is available for use in critical care settings

Hennigsdorf/Berlin, Germany, February 19, 2020 - 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.

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References
1. Beunders, R. et al., Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients, Shock,, doi:10.1097/SHK.0000000000001510
2. Depret, F. et al, PenKid measurement at admission is associated with outcome in severely ill burn patients, J.Burns, doi: doi.org/10.1016/j.burns.2020.01.002

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 penKid®
sphingotest® penKid® measures proenkephalin (penKid®), a stable fragment of the kidney stimulating hormone enkephalin. penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate, the gold standard to assess renal function. Measuring penKid® blood concentrations allows for timely information on kidney function in critically ill patients. Early assessment of worsening and improving of renal function on intensive care units and in emergency departments allows adjustment of nephrotoxic drug administration and the initiation of kidney-protective strategies to prevent acute kidney injury and thereby improve outcomes.

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 later in 2020.

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