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ProciseDx Nabs CE Mark for Infliximab, Adalimumab Point-of-Care Tests

NEW YORK – Point-of-care diagnostic firm ProciseDx announced Wednesday that its tests measuring levels of infliximab and adalimumab received CE marking for use on its ProciseDx immunoassay system.

The Procise IFX and Procise ADL tests offer diagnostic data for therapeutic drug monitoring in less than five minutes from fingerstick blood, the company said in a statement. The tests "will allow improved treatment for European patients currently using TDM with biologics such as Remicade and Humira," it added. ProciseDx's assays quantify biomarkers for drug levels, metabolic syndrome, diabetes, and celiac and inflammatory diseases.

Before these tests, TDM patients previously had to wait for up to one week for results, delaying the adjustment of their medication doses.

Earlier this year, the San Diego-based firm received CE marking for its C-reactive protein assay. It also raised $10.5 million in a Series A financing round led by French diagnostics company Biosynex.