Prediction of disease course and treatment escalation in ulcerative colitis through gut microbiota

Offentlig prosjektsammendrag

Genetic Analysis is a Norwegian biotech company with a dedicated team of scientists with expertise within molecular biology, clinical research and bioinformatics/biostatistics. The company has previously CE-marked and launched the GA-map Dysbiosis test. The test is offered as an IVD version to laboratories in Europe and as "research use only" in the US. As of today, there are no solutions able to predict if an individual ulcerative colitis (UC) patient will suffer from mild or severe disease course and finding the appropriate treatment scheme is therefore still an unmet medical need. The intestinal microbiota represents a dynamic environment in which the relative balance of the composition of pro- and anti-inflammatory bacteria species is known to be highly relevant. Mapping of the intestinal microbiota can therefore provide a unique insight to the mechanisms predicting disease course of ulcerative colitis patients, to find the most effective treatment scheme. In this project, Genetic Analysis will develop an easy to use, in vitro diagnostic test that predicts disease course and treatment escalation requirements in patients with ulcerative colitis. Through gut bacteria profile recognition, the test will provide actionable results to allow for informed decisions regarding disease management and treatment. Importantly, the intervention can be used by any molecular diagnostics laboratory, and will therefore be easily accessed by the health care. The development and validation of the test will be done in collaboration with highly experienced clinical partners. This project will build on GAs expertise in human microbiota testing and the overall aim is to provide novel insight into the causal relationship between microbiota composition and clinical conditions and indications. Ultimately this will enable physicians to provide personalized and targeted treatment to patients.