ProciseDx™ Announces CE Mark for Point of Care Platform and Plans for Additional Financing in Q1 2020

SAN DIEGO, Sept. 25, 2019 /PRNewswire/ -- ProciseDx, an in vitro diagnostics (IVD) company focused on the development of a broad portfolio of rapid diagnostic tests for the physician's office, today announced the attainment of CE mark for its ProciseDx instrument platform and the company's plans to complete additional financing in Q1 2020. The announcements reflect the company's strategic focus of developing and commercializing near-patient, two to five minute tests to precisely quantify diagnostic and treatment monitoring markers for inflammatory and auto-immune diseases, such as celiac, and metabolic syndromes, including diabetes and pre-diabetes. ProciseDx was created as a spinoff corporation from Prometheus Laboratories after its acquisition by Precision IBD in June 2019. ProciseDx is a wholly owned subsidiary of Nestlé Health Science.

ProciseDx is led by CEO, Larry Mimms, former CSO of Prometheus Laboratories and Executive Vice President at Gen-Probe, and President, Peter Westlake, former CFO of Prometheus Laboratories. Dr Mimms was the 2017 winner of the Ullman Award for Technology Innovation from the American Association of Clinical Chemistry which honors individuals with breakthrough technology contributions in this field. He also led the work at Gen-Probe which won the National Medal of Technology in 2006.

"We have been working in stealth mode with Nestlé's support for the last 3 years to develop this unique point of care diagnostic platform. We are very excited to have the opportunity to build a diagnostics company with revolutionary and disruptive technology and to launch this platform in Europe next year," said Dr. Mimms, CEO ProciseDx.  "We are currently conducting FDA clinical trials in the US and will submit a 510k in Q1 2020 for the instrument platform and the first of several assays."

"We anticipate our first round of external financing to be completed by Q1 2020, enabling us to rapidly expand the ProciseDx assay menu with high value markers in US and Europe." said Peter Westlake, President, ProciseDx.  "Our management team has over 150 years of IVD experience, having developed and commercialized several ground-breaking products. ProciseDx is well placed to benefit from growing demand for near-patient testing."

About 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, retail clinics and urgent care. ProciseDx currently has 24 employees, 10,000 sq. ft of office, laboratory and manufacturing space and is ISO13485 certified.

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