Origin Sciences Ltd has initiated a performance study of its OriCol device in measuring calprotectin, a validated biomarker of inflammation, in the stool and rectal mucus of people with known or suspected cases of inflammatory bowel disease (IBD).
IBD is characterized by ongoing inflammation of the digestive tract, such as the colon and small intestine. The main symptoms are abdominal pain, weight loss, internal cramps/muscle spasms, vomiting, diarrhea, and rectal bleeding. IBD is commonly confirmed through biopsies, and calprotectin testing is useful for an initial determination of possible IBD.
Testing for calprotectin is recommended by The National Institute for Health and Care Excellence (NICE), in the U.K., to distinguish IBD conditions, such as Crohn’s disease and ulcerative colitis, from irritable bowel syndrome.
The open, prospective study will evaluate the performance of the OriCol device in collecting mucocellular material from the rectum, and measuring calprotectin levels in stool samples taken at several hospitals in the United Kingdom. John McLaughlin, a professor of Gastroenterology and Nutrition at Salford Hospital, will serve as principle investigator.
Previous studies have established the efficiency of the OriCol device in sampling and collecting biomolecules, including DNA and proteins, as well as biomarkers like calprotectin and hemoglobin, the company said in a press release.
“OriCol™ is already being adopted for gastrointestinal research studies looking at the gut microbiome and diseases such as cancer and IBD. We are excited to be validating the device for calprotectin testing, which will expand our offering into clinical diagnostics for bowel disease,” said Paul Weinberger, CEO of Origin Sciences. “In future we anticipate that our products will improve compliance and enhance the effectiveness of colorectal cancer screening programmes.”
Origin Sciences is a medical technology company specialized in the development of sampling and diagnostic devices for people with gastrointestinal diseases. It launched the OriCol device in 2014 to help detect gastrointestinal conditions.
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