Following product launches in the United Kingdom (UK) and Ireland earlier this year, the developer of the first validated test for inflammatory bowel disease (IBD) now has reached commercialization agreements in the U.S. and Canada, and across French-speaking Europe.
That developer, PredictImmune, is partnering exclusively in North America with KSL Biomedical (KSL) to bring to market the pioneering prognostic biomarker test PredictSURE IBD. The pact calls for KSL to commercialize the product and fulfill orders, and to receive and process samples through its molecular testing lab.
PredictImmune called the agreement — marking its first launch outside the UK — a “significant milestone” in its quest to make the assay available globally. PredictSURE IBD is expected to be available in North America by the first quarter of next year.
“PredictSURE IBD is a major step towards personalized medicine in IBD and we are delighted that, via our partnership with KSL, patients across North America will now have access to this prognostic tool to enable informed treatment decisions to be made at the point of diagnosis,” Paul Kinnon, PredictImmune CEO, said in a press release.
“This is an exciting test, serving unmet needs on several levels,” said Long Shen, KSL’s chief scientific officer.
“Gastroenterologists want the best assessment of prognosis to inform their choice of treatment and deliver patient benefits, driven by an improved understanding of the implications of diagnosis and more effective implementation of the best therapy. All while lowering the cost of treatment. It’s a win-win-win,” Shen said.
KSL focuses on advancing genomic and proteomic translational medicine for therapeutic and diagnostic applications in immunology and oncology. PredictImmune develops prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated disorders.
Meanwhile, in its first product launch in mainland Europe, PredictImmune also has entered into a partnership with Theradiag, a France-based molecular diagnostics company. Under this agreement, Theradiag will have sole rights to promote, license, and distribute PredictSURE IBD to clinicians in France, Belgium, Luxembourg, and Switzerland, along with countries in Northwest Africa. Kinnon called the deal “another significant step” in marketing the diagnostics test worldwide.
“We are very pleased and honoured to have been chosen by PredictImmune for these specific missions across these five geographic areas,” Bertrand de Castelnau, Theradiag CEO, said in a press release about this agreement. “This partnership highlights our excellent knowledge of our markets, and we believe we are well positioned to help PredictImmune roll out its plan to develop its products abroad and specifically in these territories.”
A major step toward personalized medicine in IBD — a group of disorders that includes Crohn’s disease and ulcerative colitis — the blood-based test is based on a proprietary algorithm and a decade of extensive research into gene expression profiling of CD8+ T cells, a type of immune cell.
Developed in partnership with the University of Cambridge, PredictSURE IBD gives patients and healthcare professionals clear insight into the disease’s likely course — differentiating between an aggressive or relatively milder disease form — and more-informed therapeutic options at the point of diagnosis. With a better understanding of how the disease may affect individual patients, strategies such as lifestyle changes to enhance disease management can be discussed, implemented earlier, and monitored.
On the heels of a £10 million (about $12.8 million) fundraising effort, PredictImmune will offer its IBD test as both a laboratory test and as a kit, depending upon global market needs and requirements.
Characterized by chronic inflammation of the gastrointestinal tract, the autoimmune disease IBD affects some 10 million individuals worldwide.
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