NEW YORK – ProciseDx said Friday that it has received the CE mark for its Procise CRP (C-reactive protein) assay.
The company said it is completing its first clinical trials in the US and plans to apply for marketing clearance to the US Food and Drug Administration for its instrument and Procise CRP assay in the first quarter of this year.
In September last year, the firm had announced it received the CE mark for its point-of-care immunoassay instrument.
San Diego-based Procise said receiving the CE mark for its CRP assay advances its strategy to develop and commercialize two- to five-minute point-of-care tests. Its instrument and assays use fingerprick blood or stool samples to quantify biomarkers for drug levels, metabolic syndrome, diabetes, and celiac and inflammatory diseases.
Peter Westlake, president of ProciseDx, said in a statement that the firm anticipates launching its platform and gastrointestinal assay portfolio in Europe later this year. He said that the firm will open a financing round in Q1.