Developed in partnership with the University of Cambridge, the assay, called PredictSURE IBD, is the first validated predictive test for IBD, including Crohn’s disease and ulcerative colitis, to become available for the public.
“We are excited to see PredictSURE IBD become available to U.K. and Irish patients, particularly because we understand the life-changing benefits that early and accurate prediction of the likely course of their IBD disease can have on their quality of life,” Paul Kinnon, PredictImmune’s CEO, said in a press release.
IBD is an autoimmune disease with a range of symptoms. Some patients have a severe form of the disease, experiencing frequent flares and needing strong medications, while others have a milder form with infrequent flares.
Predicting the outcome of the disease is crucial to providing patients with appropriate and personalized treatment. To do this, it is necessary to identify biomarkers that predict disease outcome.
Researchers at the University of Cambridge discovered that the T cells CD8+ (a type of immune cell) had a set of biomarkers with a genetic signature that differentiated patients with severe IBD from those with the mild form of the disease at the time of diagnosis.
To identify this genetic signature, the researchers investigated the genetic profile of 69 Crohn’s disease patients and then validated their findings in 123 patients with IBD recruited from clinics around England.
This 10-year study led to the development of PredictSURE IBD, a blood test that predicts the form of the disease from the time of diagnosis with a 90%–100% accuracy. The test uses equipment and techniques that are already available in many U.K. hospitals, and its use is supported by the National Institute for Health and Care Excellence.
“In summary, we have developed, optimized and validated a whole blood gene expression biomarker that can predict prognosis in patients with either [Crohn’s disease (CD) or ulcerative colitis (UC)]. This provides a rational basis for personalized therapy in IBD and represents an important step towards precision medicine for patients with CD or UC,” the study concluded.
The test aims to provide a personalized treatment option for IBD patients, allowing patients who are likely to have severe disease to make the relevant lifestyle changes and start receiving the appropriate medication early, while at the same time it helps to avoid putting patients with the mild form of the disease on strong medicines with adverse side effects.
PredictImmune is further testing the prognostic ability of PredictSURE IBD in the ongoing PROFILE Phase IV trial (ISRCTN11808228). By 2020, the trial expects to enroll 400 patients with newly diagnosed Crohn’s disease. It will evaluate if using the test to personalize treatment will improve disease outcome and reduce the number of flares. The trial is not testing any new therapies, but rather assessing if PredictSURE IBD can predict the most suitable line of treatment.
“IBD can be a very debilitating disease, but this new test could help us transform treatment options, moving away from a ‘one size fits all’ approach to a personalized approach to treating patients,” professor Ken Smith, senior author of the study and head of the department of medicine at Cambridge University, said in another press release.
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