SAN DIEGO, Feb. 23, 2021 /PRNewswire/ — ProciseDx Inc. announced today that it has received CE mark for its Fecal Calprotectin (Procise FCP™) point of care tests for use on the ProciseDx™ system. Offering a point of care test for fecal calprotectin will help many physicians expedite their diagnosis of Crohn’s Disease or Ulcerative Colitis, as well as other digestive conditions. The test can be completed in under 5 minutes with the ProciseDx platform.
Typically, a patient must provide a stool sample in a large container and deliver it to their doctor’s office or laboratory. That facility must have special areas with special equipment for handling of such samples. The stool sample used for the Procise FCP test can be collected at home by the patient with a simple device which meters the stool into a liquid buffer for direct testing. This eliminates any difficult steps which may require special equipment or lab space for typical stool samples.
The test is available now for ProciseDx distributors to sell in their CE regions.
This solution should enable GI facilities in Europe to improve and accelerate their patients’ care. Geert D’Haens, Professor Gastroenterology at Amsterdam Medical Center, commented “The real benefits of GI Point-of-Care testing are the clinical implications of faster diagnosis and monitoring. For example, with an IBD patient that is flaring, I could confirm a flare with a CRP and Fecal Calpro, and then optimize the treatment right away.”
ProciseDx VP of International Jacques Cavadenti emphasized how significant this product launch is, “Our Point of Care menu now includes inflammatory markers (Procise CRP™ and Procise FCP™) as well as Therapeutic Drug Monitoring (Procise IFX™ and Procise ADL™). So, the ProciseDx platform empowers the gastroenterology community to start delivering true point of care solutions to their patients.”
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 currently has more than 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 www.procisedx.com.
SOURCE ProciseDx Inc