The Procise C-reactive protein (CRP) assay from ProciseDx, San Diego, has received a CE mark. Award of the mark follows the announcement of CE marking for the ProciseDx instrument in September 2019.
The ProciseDx instrument is about the size of a shoebox and can provide diagnostic results in as little as 2 minutes from a fingerstick drop of blood.
ProciseDx is an in vitro diagnostics company focused on the development of a broad portfolio of rapid diagnostic tests for the physician’s office. The Procise CRP assay fits the company’s strategy of developing and commercializing 2- to 5-minute point-of-care tests that are easy, immediate, and accurate. The tests use fingerstick blood or stool samples to quantify biomarkers for celiac disease, diabetes, inflammatory diseases, metabolic syndrome, and therapeutic drug levels.
“We are very excited to have the opportunity to build a diagnostics company with revolutionary and disruptive technology,” says Peter Westlake, president of ProciseDx. “We are launching our platform and gastrointestinal assay portfolio in Europe later this year. We’re also completing our first clinical trials in the United States and plan an FDA 510(k) submission for the instrument system and Procise CRP in Q1 2020.”
For more information, visit ProciseDx.