Healthcare Industry News: HSMN NewsFeed

Diagnostics Regulatory

 News Release - January 10, 2020

ProciseDx(TM) Announces CE Mark for Point of Care Inflammatory Marker Assay

SAN DIEGO, Jan. 10, 2020 -- (Healthcare Sales & Marketing Network) -- 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. The ProciseDx instrument is about the size of a shoe box and can provide diagnostics results in as 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."

About ProciseDx Inc.

ProciseDx is a diagnostics company committed to the development and commercialization of a broad portfolio of point-of care diagnostic tests for use in physician offices, urgent care and retail clinics. ProciseDx has 24 employees, 10,000 sq ft of office, laboratory and manufacturing space and is ISO13485 certified.

ProciseDx is headquartered in San Diego. For more information about ProciseDx, please visit us at www.procisediagnostics.com.


Source: ProciseDx

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