CE Mark Granted for Point-of-Care Inflammatory Marker Assay

ProciseDx has received CE mark approval 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 little as two minutes from a finger prick 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. This announcement advances the company’s strategy of developing and commercializing two- to five-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 U.S. 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.”
 
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 square feet of office, laboratory, and manufacturing space, and is ISO13485 certified.
 
Last fall, ProciseDx and Lumiphore signed an agreement on incorporation of Lumiphore’s new metal luminescent reporter technology in ProciseDx point-of-care diagnostic tests.
 
Under the agreement, ProciseDx has the exclusive worldwide rights to use Lumiphore’s new technology in its diagnostic tests. First offerings will be for inflammatory and autoimmune diseases such as celiac and metabolic syndromes.
 
“Lumiphore can bring the benefits of lanthanide-based homogenous mix-and-read assays, known as time-resolved fluorescence resonance energy transfer (TR-FRET) assays, to the diagnostic markets, from central labs to point-of-care applications. Detection sensitivity and simplicity of use as well as material cost reductions in reagent use, labor, and reader platforms are all benefits of Lumiphore’s new reporter technology,” said Steve Blose, Lumiphore’s chief business officer.
 
“Using Lumiphore’s technology enables ProciseDx to offer rapid, quantitative and easy point-of-care tests. We are excited to bring these tests to market in 2020.” said Dr. Larry Mimms, ProciseDx’s CEO.