The jointly sponsored study will validate PredictSURE IBDTM, claimed to be the first prognostic test for IBD, in the US. Credit: User:KGH

Prognostic solutions developer PredictImmune has announced the commencement of the PRECIOUS (Predicting Crohn’s and Colitis Outcomes in the United States) trial, which is being jointly funded by the Crohn’s & Colitis Foundation.

The PRECIOUS study will recruit up to 200 patients from approximately 15 centres across the US. It is a multi-centre, observational study of patients suffering with active Crohn’s disease or ulcerative colitis but not receiving systemic steroids, immunomodulators or biologics.

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Initially, patients will be recruited at the New York University/Bellevue. After the collection of initial blood samples, progress of the patients will be constantly monitored for up to 12 months.

Using PredictImmune’s PredictSURE IBDTM biomarker, the study patients will be categorised into high-risk and low-risk groups.

PredictImmune CEO Paul Kinnon 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 underway, 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.”

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Crohn’s & Colitis Foundation chief scientific officer Caren Heller 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 IBDTM 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.”

It is claimed to be the first prognostic test for IBD (inflammatory bowel disease) in the US.

The PredictSURE IBDTM will classify patients based on their risk of subsequently experiencing a severe disease that requires multiple treatments.

This study will offer data required to validate the PredictSure IBD test in patients. The biomarker is based on decade-old research into gene expression profiling of CD8+ T cells conducted by researchers at Professor Ken Smith’s laboratory at the University of Cambridge.

The commencement of the study follows PredictImmune’s recent exclusive partnership with KSL Biomedical (KSL) for the commercialisation of PredictSURE IBDTM across North America.

As per this agreement, KSL is responsible for the management and facilitation of meeting orders for PredictSURE IBDTM, as well as receiving and processing all samples.