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ProciseDx Gets CE Mark for Point-of-Care Inflammatory Bowel Disease Test

NEW YORK — ProciseDx said on Tuesday that it has received CE marking for its Procise FCP point-of-care test for inflammatory bowel disease.

The fecal calprotectin test, which runs on the company's CE-marked ProciseDx immunoassay system and can be completed in less than five minutes, is designed to assist in the diagnosis of Crohn's disease, ulcerative colitis, and other digestive conditions. Stool is collected by patients at home into a device that mixes the sample with a liquid buffer for direct testing.

In September, San Diego-based ProciseDx received the CE mark for its therapeutic drug monitoring Procise IFX and Procise ADL tests, which measure levels of infliximab and adalimumab, respectively. Earlier last year, the firm received the CE mark for its Procise CRP C-reactive protein assay.

"Our point-of-care menu now includes inflammatory markers, as well as therapeutic drug monitoring," Jacques Cavadenti, VP of international at ProciseDx, said in a statement. "So, the ProciseDx platform empowers the gastroenterology community to start delivering true point-of-care solutions to their patients."