Project: To develop a certified diagnostic test for monitoring disease activity in patients with inflammatory bowel disease
Background_x000D_Inflammatory bowel disease (IBD) represents a group of idiopathic chronic inflammatory intestinal conditions (Kaser, 2010). The two CO disease categories the term covers are Crohn’s disease (CD) and Ulcerative Colitis (UC), with both overlapping and distinct clinical and pathological features. The symptoms of IBD disease include diarrhea, constipation, pain or rectal bleeding with bowel movements. The complications may include haemorrhage, bowel perforation, intra-abdominal abscesses in CD and strictures and obstruction._x000D__x000D_IBD is a serious burden on society as currently more than 3 million patients suffer from IBD in Europe and the United states alone. As IBD is chronic and typically manifests itself before 30 years of age, patients generally require lifelong treatment and monitoring, and healthcare related costs are 3500 EUR per patient per year. Moreover, IBD is associated with a significant psychological burden of disease as education, employment, personal relationships, social and family life are all disrupted by the unpredictable occurrence of flare-ups._x000D_IBD is as a multifactorial disorder and the development and course of IBD are affected by several factors, including genetic susceptibility of the host, the composition of the intestinal microbiota, environmental factors and the host immune system (Kaser, 2010). IBD is thought to result from an inappropriate and continuing inflammatory response to commensal microbes in a genetically susceptible host (Kaser, et al, 2010; Khor et al, 2011). _x000D__x000D_Is it now generally accepted that the human intestinal microbiota play a role in IBD. Although the exact role of microbiota in IBD is not fully understood, there is strong evidence that commensal enteric bacteria provide the constant antigenic stimulation that continuously activates pathogenic T cells to cause chronic intestinal injury (Sartor, 2008). Perhaps the most important observation was found in recent molecular studies that have sought to determine whether specific alterations can be identified in the intestinal microbiota in IBD. 16S rRNA sequencing revealed a detectable difference between the intestinal microbiota in CD and UC compared to healthy controls (Frank et al, 2007). In addition, inflammatory lesions are more pronounced in areas of the intestine that contain the highest number of bacteria, and alterations in the microflora community structure can promote the development of IBD or trigger disease flare-ups in patients with IBD (Round et al, 2009). _x000D__x000D_Unmet medical need_x000D_As the human microbiota plays a significant role in the pathogenesis and disease activity of IBD patients, the composition and activity of the microbiota needs to be monitored frequently. While the current diagnostics focus on monitoring disease activity with parameters that have low predictive value (e.g. CRP, and stool analysis on fecal calprotectin) or a highly invasive nature (colonoscopy), there are currently no marketed diagnostics that provide information on microbial status. Furthermore, there are no cost-effective and easy-to-use tools that serve this goal. Therefore, there is a clear unmet medical need for the development of a clinical diagnostic that is able to monitor disease activity using personal microbial profiling._x000D__x000D_The solution_x000D_IS-pro is a patented length amplicon technology that uses the ribosomal 16S-23S interspace (IS) region. IS-pro is able to analyze more than 10.000 bacterial species simultaneously and gives insight into the composition and disturbances of complex bacterial communities. The technology is highly compatible with standard laboratory equipment and is ideally suited for use in clinical research and routine diagnostics. From each IBD patient, a personalized profile is developed which is subsequently stored in a database. Doing so, IS-pro can be used for the diagnosis of IBD, and consequently lead to personalization and monitoring of treatment._x000D__x000D_The Eurostars consortium_x000D_The consortium consists of two specialized SMEs that have complementary skills and expertise that are necessary to develop the technology into a certified diagnostic test. IS-Diagnostics brings the latest insights gained from cutting-edge research in the field of in vitro diagnostics to personalized patient care in IBD disease. Applied Maths will design and implement the complex bioinformatics algorithms needed to match the IS profiles with actual species and to develop the reference database. _x000D__x000D_Based on the results of previous research, now a Eurostars Project has been designed that aims at the development of a certified diagnostic test which will be commercialized in the EU and US. After finalization of the Eurostars project, the following steps need to be taken in order to market the IBD kit:_x000D_• Regulatory approval process (CE-IVD), and set-up RUO product line_x000D_• Software product update_x000D_• Set-up GMP Production process (incl. upscaling)_x000D_• Licensing and market launch in 2014_x000D_
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Acronym
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MODAPEP
(Reference Number: 7054)
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Duration
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01/06/2012 - 01/05/2015
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Project Topic
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Microbial profiling provides valuable clinical information of IBD patients. However, there are current no tools to monitor IBD. The aim of the consortium is therefore to develop a certified diagnostic test that monitors disease activity in patients with IBD using personal microbial profiling.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 7
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Project partner
