Kit to guide treatment management of patients with Inflammatory Bowel Disease

This is translation project with emphasis on chronic inflammatory bowel disease (IBD) where 2.2 million people in Europe suffer from the disease which for many can have devastating concequences. We have little knowledge of the etiology and inflammatory me chanisms in the early phase of the disease, whereas a new prognostic area started with the highly effective anti-TNF. Unfortunately, there is no consensus when to stop this extremely high cost therapy (annual cost of 20.000 EUR per patient). This project is established much based on original data from the research group showing that a normalization of mucosal gene transcript of TNF alpha predicts an longstanding remission after stop of the high-cost therapy. This is based on an in-house method. This is a collaboration project with Calpro that invented faecal calprotectin ELISA based test as a biomarker of inflammation in the gut. In this project both groups will develop an one step PCR step and an ELISA-based test for measurement of cytokines inclusive TN F alpha in the mucosa, respectively. A commercialization of kits for measurements of cytokines in intestinal mucosa will be of great clinical impact for making decision, especially therapeutic decisions such as to stop the high-cost biological therapy. Th is will reduce the annual costs for the health authorities for approx 1/3 of the patients on biological treatment and reduce the chance for severe adverse effects. The R&D challenges are both linked to develop a reproducible PCR test and to measure stabl e TNF amounts by ELISA in biopsies.