Summary of the IBD-BIOM Research Programme
This programme is for development of early warning diagnostics and molecular biomarker discovery for inflammatory bowel disease (IBD) using integrated 'omics' technologies. The IBD-BIOM consortium partners are a multidisciplinary team of leading academic and industrial researchers in IBD, genomics, glycomics, activomics, bionalytical services and diagnostic kits.
IBD affects 2.5 million Europeans and is rising, particularly in children who suffer aggressive forms. Symptoms include irreversible bowel damage, severe diarrhoea, abdominal pain, blood loss from the bowel and uncontrolled leakage of faeces. Current diagnostic tools are poor and treatments limited to symptom relief and surgical removal of bowel sections.
Recent genome-wide association studies (GWAS) performed by IBD-BIOM partners have identified around 100 IBD susceptibility loci, but clinical application has been limited. A promising new approach was shown in 2010 when four partners applied GWAS plus glycomics to diabetes. This led to a patent (UK 1016464.8) for antennary fucose as a highly discriminative glycan biomarker of HNF1A-MODY diabetes.
Serum glycosylation is also altered in inflammation and immune disturbances, so in IBD-BIOM we propose to apply GWAS-glycomics, expanded to include epigenetics and activomics, to the study of IBD patients. Workpackages include development of an IBD biomarker discovery and assay system (IBD-BDAS) that integrates modules for patient cohorts and samples, biochemical profiling by genomics, glycomics and activomics, and statistical analysis of the large datasets. We plan to implement an ISO 9001 quality system to cover IBD-BDAS modules and key proceses would be validated following ICH Q2(R1) and cGxP.
The IBD-BDAS will be used on biological samples from 6000 very well characterised IBD patients and controls available to our EU and US clinical partners. The aim is to discover reliable biomarkers that could allow insights into the molecular pathogenesis of IBD and development of prognostic tools and targeted therapies.
Exploitation includes use of the IBD-BDAS for discovery of useful biomarkers for IBD risk and progression and a clinical diagnostic service for early identification of IBD in susceptible patients.