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ViroGates Gets CE-IVD Mark for Point-of-Care SuPAR Critical Illness Test

NEW YORK — Danish medical technology firm ViroGates said on Wednesday that it has received CE-IVD marking for SuPARnostic POC+, a point-of-care test for a biomarker of inflammation.

The fingerstick test is designed to detect soluble urokinase plasminogen activator receptor — or suPAR — a protein that indicates inflammation and can be used as a biomarker to assess the presence, severity, and progression of a range of conditions including cardiovascular disease, kidney disease, type 2 diabetes, and cancer, according to the company.

According to ViroGates, evaluating a patient's suPAR levels can be used to make decisions on the hospitalization or discharge of acute care patients.

ViroGates said that it intends to evaluate the test in a clinical study prior to launching it commercially. Currently, commercialization is expected in the first quarter of next year.

"The product performs according to pre-defined criteria and has been tested with multiple users during the analytical and clinical validation," ViroGates CEO Jakob Knudsen said in a statement. "We want to make sure that our customers are comfortable with the product, and hence we aim to include even more users before a full commercial rollout. The product will broaden the market for triage using suPAR as a biomarker since many smaller and more rural hospitals can now be engaged in early triage and risk stratification of acute medical patients."