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

Inflammatory bowel disease (IBD) is a group of common chronic diseases involving bowel
inflammation. Ulcerative colitis and Crohn’s disease are the most important conditions of this
group. IBD is usually diagnosed in young adults. As a rule it is characterized by long
remissions and incidental flare-ups requiring treatment. IBD should be distinguished from noninflammatory
functional disorders, in particular from extremely common irritable bowel
syndrome (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. All
of them should be monitored for possible relapses. Those developing relapses are treated;
therefore treatment choice, treatment adequacy and efficiency assessment and long-term
monitoring are important tasks in need of serious improvements.
DiagNodus Ltd has developed a new method of non-invasive collection of biological material
from the anal area following natural bowel opening. This simple procedure based on sample
self-collection is non-invasive and safe. The collected material predominantly derives from
colorectal mucus. It contains cells in abundance and can be used for diagnostic biomarker
testing.
The proposed pilot clinical trial is focused on comparatively evaluating performance of a
range of protein biomarkers for: a) IBD detection by comparing groups of 60 patients with
IBD and 60 patients with IBS; b) IBD treatment adequacy and efficiency assessment in the
IBD group; c) IBD monitoring by following-up the IBD group. The results of the trial
obtained by laboratory analysis will identify the most suitable protein biomarkers for
prototyping a family of products including point-of care and laboratory tests for IBD
diagnosis, therapeutic modality choice, treatment efficiency assessment and monitoring.