PredictImmune to launch study of PredictSURE IBD test in US with Crohn’s & Colitis Foundation
A study is under way to validate PredictImmune’s unique prognostic test for inflammatory bowel disease (IBD) in the US.
The Babraham Research Campus-based company will jointly fund the work with the Crohn’s & Colitis Foundation.
Called PRECIOUS - Predicting Crohn’s and Colitis Outcomes in the United States - the observational study will recruit 200 patients from 15 centres across the country, and has begun at New York University and Bellevue Hospital.
Patients with active Crohn’s disease or ulcerative colitis, who are not receiving systemic steroids, immunomodulators or biologics, will be tracked for up to 12 months after an initial blood sample is taken.
Using PredictImmune’s PredictSURE IBD test, which was successfully launched in the UK and Ireland in April, patients will be stratified at diagnosis into high and low-risk cohorts, based on their chance of experiencing major relapses or a chronically active disease.
The test is based on a decade of research into gene expression profiling of CD8+ T cells by researchers in Professor Ken Smith’s at the University of Cambridge.
PredictImmune’s CEO, Paul Kinnon, who was shortlisted for CEO of the Year at the Cambridge Independent Science and Technology Awards, said: “We see our partnership with the Crohn’s & Colitis Foundation as a positive step for both PredictImmune and IBD patients in the US.
“It’s exciting to get the PRECIOUS study under way, enabling us to extend our validation cohort and reinforce the utility of the test in delivering insights into the long-term disease course of IBD patients at the point of diagnosis.
“The study takes both PredictImmune and the Crohn’s & Colitis Foundation a step closer to a common goal of improving disease outcomes and quality of life for patients with IBD in the US.”
PredictImmune, which was highly commended in the Medtech Company of the Year category at our awards, span out of the Department of Medicine at the University of Cambridge in 2017. It completed a £10million funding round in August to further its aim of becoming the first company to offer predictive tests in immune-mediated diseases such as IBD, lupus and multiple sclerosis.
Since the UK and Ireland launch, for which Addenbrooke’s was a partner, PredictImmine entered a strategic agreement with French diagnostic specialist Theradiag, to commercialise PredictSURE IBD in France, Belgium, Luxembourg, Switzerland and the Maghreb countries.
And it recently announced an exclusive commercial partnership with KSL Biomedical (KSL), to promote and provide PredictSURE IBD throughout North America.
KSL will manage and facilitate the fulfilment of orders of PredictSURE IBD, as well as receive and process all samples.
Caren Heller, chief scientific officer of the Crohn’s & Colitis Foundation, said: “There is a critical need for improved biomarkers in IBD to advance us toward precision medicine and improving patient care.
“The validation of the PredictSURE IBD biomarker in the US would be a great step toward the goal of treating the right patient, with the right therapy, at the right time.”
Lea Ann Chen, the US PI for the PRECIOUS study, added: “Personalised therapy is key to optimising outcomes and minimising risks for our patients with IBD. It is also dependent on having accurate predictors of disease behaviour.
“That is why we're particularly excited to be a part of the PRECIOUS study. In expanding the validation of PredictSURE IBD™ for patients in the US, we hope to advance the efforts that will allow each patient to determine his or her best treatment options.”