The Crohn's & Colitis Foundation, the leading non-profit organization focused on both research and patient support for inflammatory bowel disease (IBD), has entered into a partnership with LifeArc, an independent medical research charity that advances translation of early science into health care treatments or diagnostics, to potentially develop the first clinical lab test to predict disease course in pediatric patients with Crohn's disease and response to treatment.
A prognostic test which could accurately predict which children will develop complications and identify patients most likely to benefit from anti-TNF therapy would help clinicians make effective early treatment decisions to improve outcomes.
There is an urgent need for a prognostic test for early prediction of fibrotic and fistulizing complications which could require surgery. The ability to predict disease course and develop treatment protocols to address potential complications would be a major advancement toward delivering precision medicine for pediatric Crohn's disease, and the Foundation is excited to be leading the way. With early understanding of disease course and response to treatment physicians and parents could make decisions based on patient's biological and clinical characteristics to deliver the right drug at the right time to the right patient."
Andrés Hurtado-Lorenzo PhD, Vice President of Translational Research
The development of the clinical test advances the findings of the Foundation's Pediatric RISK Stratification Study, the largest, new-onset study completed on pediatric Crohn's disease patients. Researchers successfully identified biological signatures capable of predicting if a child newly diagnosed with Crohn's disease will develop disease-related complications. The pediatric RISK study provided proof of concept that the analysis of intestinal gene expression patterns can prognosticate disease course at diagnosis.
The Foundation is driving the translational research needed to improve and develop both a prognostic test and a treatment response test. LifeArc is investing R&D expertise and resources to advance toward product development.
"LifeArc's Centre for Diagnostics Development is excited to be working with the Crohn's & Colitis Foundation in the development of this innovative assay in diagnosing potential future complications and response to treatment for paediatric Crohn's patients," said Dr. Ciaran Fulton, Associate Director and Head of Diagnostics at LifeArc. "Our team has helped to develop diagnostic opportunities in advanced breast cancer, and undertake disease monitoring in tuberculosis where our expertise in design, development and clinical evaluation of assays advances new tests toward the clinic to benefit patient outcomes."
The Crohn's & Colitis Foundation translational research team, in collaboration with Genedata, a leading bioinformatics company, used artificial intelligence methods for analysis of the RISK study data to identify novel optimized biological signatures for assay development and validation in prospective studies, enabling the initiation of development of these new gene expression-based tests.
The Foundation and LifeArc are working toward developing the prototype with the goal of advancing a product to market within the next four years.