CAMBRIDGE, U.K.—Prognostic tool development company PredictImmune announced its first partnership of 2020 this week: a commercial supply agreement with Cambridge Clinical Laboratories (CCL), centered on PredictImmune's PredictSURE IBD test. CCL offers testing services in a variety of indications, including oncology, virology, fertility, sexual health and autoimmune disease.
While no financial details were disclosed, the agreement stipulates that CCL will fulfill all orders of PredictSURE IBD, in addition to receiving and processing all samples. The agreement covers the U.K., Ireland (non-exclusive), the Middle East and the Balkans (exclusively).
“At Cambridge Clinical Laboratories, we provide healthcare professionals worldwide with the most advanced testing services. We’re delighted to be working with PredictImmune and adding PredictSURE IBD; it will be a great addition to our library of services,” Tony Cooke, CEO of Cambridge Clinical Laboratories, commented in a press release. “This test, which will be available from mid-February, will be a life-changer for patients at the early stage of their diagnosis. We would encourage anyone who feels this test could be appropriate for them to speak to their healthcare provider.”
PredictImmune's test is the first validated, CE-marked prognostic test for guiding treatment decisions for patients with inflammatory bowel disease (IBD) (specifically Crohn's disease and ulcerative colitis). The blood-based biomarker test is based on gene expression profiling of CD8+ T cells, and allows gastroenterologists to determine whether their patients are likely to face a mild or aggressive form of their disease and decide on the best treatment approach soon after diagnosis.
Paul Kinnon, CEO of PredictImmune, said: “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. The adoption of PredictSURE IBD is accelerating globally, due both to this partnership and the progress we are making in our two clinical studies (PROFILE and PRECIOUS). These exciting developments are bringing the life-changing benefits that early and accurate prediction of the likely course of IBD can have on quality of life to more and more patients. We look forward to a long-lasting and rewarding partnership with the CCL team.”
The PRECIOUS study, which PredictImmune is jointly funding together with the Crohn's & Colitis Foundation, began in November 2019 as a multi-center, observational study of up to 200 patients with active Crohn's disease or ulcerative colitis who are not taking systemic steroids, immunomodulators or biologics. Using the PredictSURE IBD test, patients will be classified at the time of diagnosis as being either low-risk or high-risk for a severe disease progression, and will be followed for up to 12 months.
As for the PROFILE study, PredictImmune announced on January 7 that it had recruited more than 200 patients, halfway to its recruitment goal. Recruitment for the study began in December 2017, and the study, which is funded by Wellcome Trust, is aiming to enroll 400 newly diagnosed individuals with active Crohn's disease. PredictImmune reported that PROFILE is the first biomarker stratified trial for Crohn's disease, and it will aim to prove that “stratifying patients based on their risk of experiencing a frequently relapsing disease course, coupled with top-down or step-up treatment options, will result in improved outcomes.”
“I am delighted to see this important recruitment milestone reached. PROFILE is a groundbreaking trial—the first of its type in any inflammatory disease, evaluating a new test which we believe will predict the future behavior of Crohn’s disease, and help clinicians to target the right treatment to the right patient from the beginning,” remarked Dr. Miles Parkes, chief investigator for the PROFILE trial. “This is an essential part of ‘personalized medicine,’ and has the potential to dramatically improve outcomes for our patients. Recruiting to any research study is always a challenge, particularly when people have just received a diagnosis of Crohn’s disease. It is testament to the dedication of participating patients and hard work of all the research nurses and clinical teams who are helping to run the PROFILE trial that we have reached the halfway mark.”