Being the world’s first diagnostic DNA chip, it has the main object to predict prognosis and response to therapy of patients suffering from inflammatory bowel disease. The programme has a 2.5 million Euro budget for the next three years for conducting several studies including a total of 3,000 - 4,000 patients in seven European countries.
A consortium including seven leading European centres in inflammatory diseases and genetics; an enterprise with the technology for manufacturing the chip; and a leading enterprise in laser technology, in charge of optimizing the reading of the chips, has been created for conducting this project (see Annex). This consortium is coordinated by Dr. Miquel Sans, researcher of the IDIBAPS Physiopathology of Gastrointestinal Lesions Group and member of the Gastroenterology Facility of Hospital Clinic de Barcelona.
The IBDchip (Inflammatory Bowel Disease DNA Chip) is a DNA chip especially developed by the Basque company Progenika Biopharma in collaboration with Dr. Miquel Sans of Hospital Clinic. The chip is a simple device requiring only a small blood sample. The DNA is obtained from this sample, which is placed in a glass support (the IBDchip) for the detection of 61 mutations, using laser technology.
Crohn’s disease and colitis ulcerosa are highly heterogenic pathologies with unpredictable clinical course and drug response. The prevalence of these diseases has significantly increased in developed countries during the last decades. In Spain, more than 100,000 people are affected, and the incidence of the disease is 15–20 new cases per 100,000 inhabitants and year. The number of patients in Europe rises to 1.5 million. 15 % of patients have at least one relative suffering from one of these pathologies, which involve an important loss of quality of life. The treatment costs are of 7,382 Euros per year and patient, meaning a total cost of 1,000 million Euro per year for the public healthcare system. Thus, a device allowing a reliable prediction of the clinical course and the probability of response to several treatments in each patient would be highly useful.
Spain in the Lead
The technology underlying the IBDchip (DNA chip with a glass support) was presented in Biscay last January. At present, the statistic analysis of the first Spanish IBDchip Study aiming to predict the clinical course of Spanish intestinal bowel disease patients is being conducted. This work, also led by Dr Miquel Sans, includes more than 900 patients divided into two groups. The first group will permit to define a series of prediction models (one for each clinical event), whereas the second will serve as an independent indicator allowing to check the prediction model’s real usefulness.
The definitive analysis of the first and second phase of the Spanish IBDchip Study is envisaged within the next two months. These final results will determine the exact usefulness of the IBDchip in IBD Spanish patients; consequently, despite the IBDchip being already available in our country, its clinical application cannot be recommended until its prognostic value is well known.
Ongoing studies for revealing the IBDchip usefulness are not limited to our country. The new European project also aims to reveal the European usefulness of this tool. This step is indispensable –independently of the Spanish results– due to the fact tat there is a large genetic variability among the several geographic areas and ethnic groups of our continent, and the mathematical prediction models resulting from the European study will probably be different from those obtained in Spain.
As a consequence, one of the first aims of the European IBDchip Project is to identify new genetic factors with potential interest regarding intestinal bowel disease. The IBDchip’s version that will be used in such studies is likely to include more than 200 genetic factors instead of the 61 of the first phase IBDchip. Once this new version is available, the European IBDchip Project will conduct several retrospective and prospective studies with two specific purposes: on the one hand, to define its usefulness for the prognosis of IBD clinical course; and on the other hand, to reveal its efficiency for predicting the likelihood of drug response in European patients.
Other purposes of this project are the optimization of technological processes (in terms of reduction of speed, size and costs for the laser system), the study of a potential clinical routine application of the IBDchip, the analysis of legal and ethical aspects of this tool and its cost-efficiency.
ANNEX. Centres of the IBDchip Consortium and Main Researcher:
- IDIBAPS-Hospital Clínic, Barcelona (Spain) / Miquel Sans (General Coordinator).
- University of Oxford, Nuffield Department of Medicine, Gastroenterology Unit and Oxford Genetics Knowledge Park (Oxford GKP´s), Oxford (UK) / Derek Jewell.
- The University Hospital in Leuven, Gastroenterology Unit, Leuven (Belgium) / Severine Vermiere.
- VUMC Amsterdam, Laboratory of Immunogenetics, Amsterdam (Holland)/ Salvador Peña.
- University Hospital Schleswig-Holstein (UKSH), The Institute for Clinical Molecular Biology (ICMB), Kiel (Germany) / Stephan Schrieber.
- Charles University, Department of Gastroenterology, Prague (Czech Republic) / Milan Lukas
- Istituto Clinico Humanitas, Milan (Italy)/ Silvio Danese.
- Progenika Biopharma, S.A., Derio (Spain) / Marta Artieda.
- Innopsys, S.A., Carbonne (France) / Stephane Schrieber.
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