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PredictImmune Gains CE-IVD Mark for IBD Test

NEW YORK (GenomeWeb) – PredictImmune has obtained a CE-IVD mark for its debut test for inflammatory bowel disease, the company said today.

By achieving certification for the test, called PredictSure IBD, the Cambridge, UK-based firm can sell it for clinical use across Europe and other geographies that recognize the designation.

PredictSure IBD relies on a 15-biomarker quantitative PCR panel to guide treatment for Crohn's disease and ulcerative colitis. The test, which is run on Roche's LightCycler instrument, can be used to stratify patients according to the severity of their illnesses, thus enabling clinicians to decide on the best therapies.

PredictImmune CEO Paul Kinnon said in a statement that PredictSure IBD, which will be available in January, "will have a direct and significantly positive impact on the quality of treatment and outcomes for patients."

PredictImmune earlier this year pledged to launch PredictSure IBD in 2019. In April, it announced the receipt of £4.3 million ($5.9 million) from the Wellcome Trust to evaluate the use of its test to guide therapy in 400 patients across the UK. The company in May 2017 raised £4.7 million through a Series A financing round that included investors Parkwalk Opportunities, Cambridge Enterprise, and Wren Capital.

Earlier this month, PredictImmune and the Crohn's & Colitis Foundation announced a joint study to provide additional data for PredictSure IBD. The study will involve approximately 100 patients from four centers in the US and will start later this year. The effort is expected to run for two and a half years.