CE-IVD-Marked POC Test for Kidney Function Launched

Diagnostics company SphingoTec GmbH have 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, 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.

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 care; penKid® blood levels during hospitalisation can be used for real-time monitoring of kidney function; 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 AKI that require further attention.

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 commercialised 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.