The research and development work of IBDchip Project is divided in five Workpackages

WP1
Final SNP selection and Chip design

IBDchip Project aims to identify polymorphisms (SNPs) that predict IBD susceptibility, behaviour and response to therapy through systematic reviews of the medical literature, grey literature and directly from the laboratories of the involved investigators. This information will be used to design oligonucleotides for the chip that will robustly identify the IBD SNPs. In general probe length is between 19 and 27 nucleotides with the discriminatory nucleotide in the central position. Once probes have been validated, a series of optimization steps associated with sample and array processing will be performed.

WP2
Prediction of phenotype and complications in Crohn’s disease and ulcerative colitis

The Project will define what genetic factors, of those included in the IBDchip, are significantly associated with different relevant clinical outcomes previously defined for Crohn’s disease (CD) and ulcerative colitis (UC). To gather information a major new retrospective multicentre study will be carried out, involving 1.000 CD and 1.000 UC patients with a standard diagnosis, with ten or more years since diagnosis and a complete follow-up history since diagnosis in one of the partner centres. The results will provide a predictive model which results in an optimal prediction of clinical progression.

WP3
Response to Therapies

The objective of Workpackage 3 is to produce an accurate predictive model for patients’ response to a range of available therapies, based on the prospective validation of data from WP 2 through further studies on Infliximab, azathioprine (as a part of “The Aztec Study”) and other anti TNF-alpha drugs (Adalimumab and Certolizumab). The results will be integrated into a codified, robust predictive statistical model consisting of a weighted combination of the genetic factors of the IBDchip associated with response of patients with CD and UC to a range of pharmaceuticals.

WP4
Technical Optimization

To make the process ready for full widespread commercialization it is necessary to optimize the process of reading biochips. This will be achieved by applying integration technology and know-how of the project partners to develop a scanner with advanced new characteristics. The objective is to make the reading process quicker, cheaper and more accurate. IBDchip Project will provide the first prototype microscope slide scanner to be fully adapted to the new diagnostic and clinical tests markets.

WP5
Translational Activities

The project outputs for this WP will be the reports, maps of clinical pathways and economic analyses that correspond to each of the worksteps. The IBDchip has to be clinically validated to prove that it can be used as a tool to aid clinical decision making in routine settings, that it is cost effective and that all ethical and legal issues are addressed during the project development phase.