PredictImmune Partners with Cambridge Clinical to Commercialize IBD Test

PredictImmune Partners with Cambridge Clinical to Commercialize IBD Test

PredictImmune has entered into a commercial partnership with Cambridge Clinical Laboratories (CCL) to provide PredictSURE IBD — its prognostic test for inflammatory bowel disease (IBD) — to clinicians in the United Kingdom, Ireland, the Middle East, and the Balkans.

The agreement calls for the U.K.-based CCL to manage and facilitate orders for PredictSURE, the first validated predictive test for guiding treatment options in IBD, and to receive and process samples. The pact is exclusive for the Middle East and the Balkans.

After product launches in the U.K. and Ireland last year, developer PredictImmune has now reached commercialization agreements in the United States, Canada, the Middle East, the Balkans, and across French-speaking Europe. The test is expected to be available to patients by mid-February.

Developed in partnership with the University of Cambridge, PredictSURE enables clinicians and patients to know and understand, upon diagnosis, the disorder’s likely course and severity. Knowing the expected trajectory promotes optimal individualized treatment choices and potentially, lifestyle changes, which could lead to improved outcomes and quality of life.

The test represents a significant move toward personalized medicine in IBD. The assay is based on a proprietary algorithm and a decade of research into gene expression profiling of CD8+ T cells, a type of immune cell. It can predict the disease form with 90-100% accuracy.

Tony Cooke, CEO of CLL, called the test a “life-changer” for people in the early stages of Crohn’s disease or ulcerative colitis, the two most common forms of IBD.

“We would encourage anyone who feels this test could be appropriate for them to speak to their healthcare provider,” he said in a press release.

PredictImmune is further testing the assay in the ongoing PROFILE Phase IV trial (ISRCTN11808228) in the U.K., in which 400 people with newly diagnosed Crohn’s are expected to be enrolled this year. The trial will assess whether PredictSURE will improve disease outcome and lower the number of disease flares.

In addition, in collaboration with the Crohn’s and Colitis Foundation, PredictImmune’s PRECIOUS trial (NCT03952364) will evaluate whether the test can stratify 200 newly diagnosed IBD patients, ages 16 to 80, into high-risk and low-risk cohorts. That multicenter, U.S.-based observational study also is recruiting participants.

“This latest partnership will enable increasing numbers of patients across the UK and Ireland, as well as further afield, to access PredictSURE IBD and gain a greater understanding of the likely course of their disease and how best to manage it,” said Paul Kinnon, CEO of PredictImmune. “The adoption of PredictSURE IBD is accelerating globally.”

The results supporting the test were published in a study, titled “A blood-based prognostic biomarker in IBD,” in the journal Gut.