NEW YORK (GenomeWeb) – PredictImmune and the Crohn's & Colitis Foundation announced today that they will jointly conduct a study to provide additional validation and efficacy data for the company's prognostic test for irritable bowel syndrome.
The study, which will involve approximately 100 patients from four centers in the US, will start later this year and will run for two and a half years. The test is the first validated, biomarker-based prognostic test for IBD that predicts long-term disease outcome in both Crohn's disease and ulcerative colitis, PredictImmune said. It is designed to measure genetic markers in whole-blood samples in order to predict which Crohn's disease patients are likely to experience a severe, relapsing form of the disease, and enables clinicians to group patients based on their risk profile and select the most appropriate treatment for patients' predicted disease course.
"We are delighted to be working with the Crohn's & Colitis Foundation towards a common goal of improving disease outcomes and quality of life for patients with IBD in the US," PredictImmune CEO Paul Kinnon said in a statement. "Improving patient outcomes in immune-mediated diseases is at the heart of everything we do. Working in collaboration with the foundation's extensive network of clinicians, we now have the opportunity to demonstrate the efficacy of our product in a clinical setting whilst at the same time having a direct, positive impact on the quality of outcomes for US patients."
Additional terms of the collaboration were not disclosed.
In April, PredictImmune announced that it had received £4.3 million ($5.9 million) from the Wellcome Trust to clinically evaluate its biomarker test for Crohn's disease. In 2011, the test's developers at the University of Cambridge published data showing that transcriptional signatures in CD8+ T cells could be used to differentiate patients with Crohn's disease and ulcerative colitis, as well as predict disease progression.
The company said it aims to obtain a CE-IVD mark by the end of this year so that it can sell its kit on the European clinical market, and it plans to commercialize the test in Europe in 2019. PredictImmune also said it would seek to make the test available to US customers through partnerships with one or more CLIA-compliant labs, and then would run clinical studies in order to eventually submit the test to US regulators for clearance.