News Release 

sphingotec launches IVD test for kidney function biomarker penKid® on Nexus IB10 POCT platform

sphingotec GmbH

Hennigsdorf/Berlin, Germany, January 13, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf near Berlin, Germany) today announced the launch of its IB10 sphingotest® penKid®, a CE-IVD-marked point-of-care test for Proenkephalin (penKid®), 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® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate [1], the gold standard to assess kidney function. In contrast to other markers, penKid® is an early predictor of worsening and improving kidney function independently from co-morbidities and inflammation [2,3].

penKid® as a functional kidney biomarker has been demonstrated to provide significant clinical utility in numerous critical care settings:

    - penKid® 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® indicate kidney dysfunction in critically ill patients much earlier than the current standard of care4.

    - penKid® 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® reflect compromised kidney function. The normalization of kidney function is rapidly mirrored by decreasing levels of penKid®. Hence, penKid® allows for individualized dosing of medicines with nephrotoxic side-effects.

    - penKid® 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® penKid® 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® 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® penKid® 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

1. Donato L. et al., (2018): Analytical performance of an immunoassay to measure proenkephalin, Clin Biochem., doi: 10.1016/j.clinbiochem.2018.05.010

2. 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

3. Gayat E. et al, (2018) Back-to-back comparison of penKID with NephroCheck® to predict acute kidney injury at admission in intensive care unit, Critical Care, doi: 10.1186/s13054-018-1945-9

4. 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

5. 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

6. 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®), 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 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 by mid-2020.

About penKid®

sphingotec's proprietary biomarker Proenkephalin (penKid®) 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® 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.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.