In studies on more than 30,000 patients admitted to ICUs and EDs, penKid(R) has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate1, the gold standard to assess kidney function. In contrast to other markers, penKid(R) is an early predictor of worsening and improving kidney function independently from co-morbidities and inflammation2,3,.
penKid(R) as a functional kidney biomarker has been demonstrated to provide significant clinical utility in numerous critical care settings:
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(R) penKid(R) 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(R) 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(R) penKid(R) 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.
References
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(R)), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid(R)), 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(R) 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(R)), a unique and proprietary biomarker for real-time assessment of kidney function. An IB10 assay for bioactive Adrenomedullin (bio-ADM(R)), a unique and proprietary biomarker for endothelial function is expected to be launched by mid-2020.
About penKid(R)
sphingotec’s proprietary biomarker Proenkephalin (penKid(R)) 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(R) 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.
Contact
SphingoTec GmbH
Ruxandra Lenz
PR & Market Communications Manager
Neuendorfstr. 15A
16761 Hennigsdorf
Germany
Tel. +49-3302-20565-34
press@sphingotec.de
www.sphingotec.com
SOURCE: SphingoTec GmbH
View source version on accesswire.com:
https://www.accesswire.com/572838/Sphingotec-Launches-IVD-Test-for-Kidney-Function-Biomarker-penKidR-on-Nexus-IB10-POCT-Platform
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