ProciseDx™ Files 510k and Prepares for EU launch of Novel Point of Care Technology
SAN DIEGO, May 12, 2020 /PRNewswire/ -- ProciseDx announced 510k filing for Procise CRP test. The test measures C Reactive Protein (CRP) levels from fingerstick whole blood in 2 minutes. CRP is an inflammatory marker commonly used in gastrointestinal practice, and the test is performed using ProciseDx's FRET (Florescent Resonance Energy Transfer) Point of Care instrument. Procise CRP is the first of a series of 2-5 minute lab-quality tests what will be launched on the ProciseDx instrument.
ProciseDx Instrument (about 8 inches or 20cm wide) with a Procise Reagent Cartridge.
"We're delighted with the robust performance we've been able to demonstrate in our CRP 510k clinical trials," said Larry Mimms, CEO and Chief Scientific Officer of ProciseDx. "We believe that using FRET (Florescent Resonance Energy Transfer) technology brings real advantages in clinical practice. Quantitative tests from fingerstick whole blood enable easy, immediate and accurate point of care diagnostics. Today, as we file the 510k for CRP, we're completing development of a menu of tests for gastroenterology practices in Europe and the US."
To drive commercialization in Europe, ProciseDx also announced the appointment of Jacques Cavadenti, Vice President of International. Jacques joins ProciseDx with extensive point of care diagnostic commercialization experience, most recently at GenMark, where he was Vice President and General Manager, Europe. ProciseDx is preparing to launch in multiple markets in Q3 2020. ProciseDx's launch menu includes CRP, Infliximab and Adalimumab drug levels, each test from fingerstick whole blood. ProciseDx will also offer a Fecal Calprotectin assay with simple and reliable sample collection. All assays run on the same instrument in less than 5 minutes with very easy workflow.
"I'm excited to join ProciseDx just as it brings this new technology to market," commented Jacques Cavadenti. "In my experience of commercializing point of care diagnostic solutions, the key is offering the customer high quality results that are easy to implement. With the ProciseDx solution, you get easy, immediate and accurate diagnostic results. With lab-quality results from fingerstick whole blood, I anticipate lots of enthusiasm from GI's and their patients across Europe."
To facilitate a funding round in June 2020, ProciseDx announces its conversion from ProciseDx LLC to ProciseDx Inc. ProciseDx's Incorporated legal entity will enable new investors to participate.
"We're working to bring in experienced diagnostics investors to support us financially and strategically as we commercialize," said Peter Westlake, President of ProciseDx. "We've proven that this novel technology works in the clinic. As we commercialize, we see significant potential to create value for the physicians who apply our technology, for our employees and for our investors."