Development of new non-invasive tests for inflammatory bowel disease detection, monitoring and treatment assessment.

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Inflammatory bowel disease (IBD) is a group of common chronic diseases involving bowelinflammation. Ulcerative colitis and Crohn’s disease are the most important conditions of thisgroup. IBD is usually diagnosed in young adults. As a rule it is characterized by longremissions and incidental flare-ups requiring treatment. IBD should be distinguished from noninflammatoryfunctional disorders, in particular from extremely common irritable bowelsyndrome (IBS), but there is no reliable non-invasive test available for this purpose.Currently there are about 2.4 million IBD patients in Europe and up to 240,000 in the UK. Allof them should be monitored for possible relapses. Those developing relapses are treated;therefore treatment choice, treatment adequacy and efficiency assessment and long-termmonitoring are important tasks in need of serious improvements.DiagNodus Ltd has developed a new method of non-invasive collection of biological materialfrom the anal area following natural bowel opening. This simple procedure based on sampleself-collection is non-invasive and safe. The collected material predominantly derives fromcolorectal mucus. It contains cells in abundance and can be used for diagnostic biomarkertesting.The proposed pilot clinical trial is focused on comparatively evaluating performance of arange of protein biomarkers for: a) IBD detection by comparing groups of 60 patients withIBD and 60 patients with IBS; b) IBD treatment adequacy and efficiency assessment in theIBD group; c) IBD monitoring by following-up the IBD group. The results of the trialobtained by laboratory analysis will identify the most suitable protein biomarkers forprototyping a family of products including point-of care and laboratory tests for IBDdiagnosis, therapeutic modality choice, treatment efficiency assessment and monitoring.