Monday, January 13, 2020
ProciseDx today announced the attainment of CE mark for its Procise CRP assay (C reactive protein) which is the first of its family of gastrointestinal markers. This follows the announcement of CE mark for the ProciseDx instrument in September 2019.
ProciseDx is an in vitro diagnostics company focused on the development of a broad portfolio of rapid diagnostic tests for the physician's office. Today's announcement advances the company's strategy of developing and commercializing 2 to 5-minute point-of-care tests that are easy, immediate and accurate. These tests use finger prick blood or stool samples to quantify biomarkers for drug levels, metabolic syndrome, diabetes, celiac and inflammatory diseases.
"We are very excited to have the opportunity to build a diagnostics company with revolutionary and disruptive technology. We are launching our platform and gastrointestinal assay portfolio in Europe later this year," said Peter Westlake, President of ProciseDx. "We're also completing our first clinical trials in the US and plan an FDA 510k submission for the instrument system and Procise CRP in Q1 2020. With our latest funding round opening in Q1, this will be a big year for ProciseDx."