PR-Inside.com: 2020-01-13 10:15:15
sphingotec launches a CE-marked point-of-care IVD assay for Proenkephalin (penKid(R)), the company's proprietary biomarker for real-time assessment of kidney function in critical care settings
IB10 sphingotest(R) penKid(R) runs on sphingotec's automated Nexus IB10 point-of-care platform and quantitatively measures levels of penKid(R) directly in whole blood samples
penKid(R) is a functional kidney biomarker reflecting the actual glomerular filtration rate and thus allows monitoring of renal function in real-time
penKid(R) enables earlier prediction and more precise monitoring of acute kidney injury than the current standard-of-care
HENNIGSDORF/BERLIN, GERMANY / ACCESSWIRE / January 13, 2020 / Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf near Berlin, Germany) today announced the launch of its IB10 sphingotest(R) penKid(R), a CE-IVD-marked point-of-care test for Proenkephalin (penKid(R)), 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(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:
penKid(R) 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(R) indicate kidney dysfunction in critically ill patients much earlier than the current standard of care4.
penKid(R) 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(R) reflect compromised kidney function. The normalization of kidney function is rapidly mirrored by decreasing levels of penKid(R). Hence, penKid(R) allows for individualized dosing of medicines with nephrotoxic side-effects.
penKid(R) 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(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.
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References
Donato L. et al., (2018): Analytical performance of an immunoassay to measure proenkephalin, Clin Biochem., doi: 10.1016/j.
clinbiochem.2018.05.010
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
Gayat E. et al, (2018) Back-to-back comparison of penKID with NephroCheck(R) to predict acute kidney injury at admission in intensive care unit, Critical Care, doi: 10.1186/s13054-018-1945-9
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
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
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(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, i
