ProciseDx Achieves CE Mark for Infliximab and Adalimumab Point of Care Testing

SAN DIEGO, Sept. 9, 2020 /PRNewswire/ — ProciseDx Inc. announced today that it has received CE mark for its infliximab (Procise IFX™) and adalimumab (Procise ADL™) point of care tests for use on the ProciseDx™ system.  Previously, patients and physicians had to wait up to one week for drug level test results which delayed dose adjustment for 2 to 6 weeks. Each test provides valuable diagnostic data for therapeutic drug monitoring (TDM) in less than 5 minutes with fingerpick blood. This advance will allow improved treatment for European patients currently using TDM with biologics such as Remicade® and Humira® as part of their treatment regimen.

Key members of the gastrointestinal community throughout Europe have been searching for this solution to improve their patients’ care. “With ProciseDx, we will be able to measure levels of infliximab and adalimumab in five minutes from fingerstick blood,” stated Geert D’Haens, Professor of Gastroenterology at Amsterdam Medical Center. “This information during the patient visit will be incorporated into our immediate treatment decisions.”

“We expect that this development of rapid TDM and immediate knowledge of drug levels will allow physicians to make timely dosing decisions and thereby improve drug efficacy. We want to make therapeutic drug monitoring as beneficial as possible for the patient,” said ProciseDx CEO Larry Mimms. “By bringing testing to the point of care, drug dosing can be adjusted on the spot instead of waiting a week or longer for results.”

The CE Mark allows distributors in Europe to sell the ProciseDx platform with CRP, IFX and ADL assays, with more assay menu coming soon. On July 21st ProciseDx announced that Biosynex S.A., a French diagnostics company, had become a shareholder in ProciseDx and would distribute the ProciseDx menu in France.

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, retail clinics and urgent care. ProciseDx has 30 employees, 30,000 sq. ft. of laboratory, manufacturing and office space and is ISO13485 certified. ProciseDx is headquartered in San Diego, California.

For more information about ProciseDx, please visit us at

Peter Westlake

SOURCE ProciseDx Inc

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