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The test is designed to analyze the expression of 17 genes in order to differentiate mild and aggressive forms of Crohn's disease and ulcerative colitis.
Takeda said that the tool evaluates risk for developing complications associated with Crohn's disease and helps support personalized clinical decision-making.
The study will recruit up to 200 patients with active Crohn's disease or ulcerative colitis and sort them into high- and low-risk cohorts using the PredictSure IBD test.
Under the deal, KSL will commercialize and facilitate orders of the PredictSURE IBD test throughout North America and will also process all samples through its laboratory, KSL Diagnostics.
The device is intended for preparation of stool samples and use with Buhlmann's Fcal Turbo calprotectin test.
Under the expanded deal, PredictImmune will have first right of refusal on technologies for predicting disease outcome for systemic lupus erythematosus.
An increased blood-to-stool ratio in the concentration of bacterial short-chain fatty acids marked higher permeability in the intestinal wall.
Addenbrooke' Hospital will manage and facilitate the fulfillment orders of the firm's PredictSure IBD orders, as well as receive and process all samples.
Changes in physician behavior around monitoring patient response to therapeutic monoclonal antibodies is increasing demand for clinical testing of these drugs.
The test is a 15-biomarker quantitative PCR panel used to stratify patients with Crohn's disease and ulcerative colitis based on the severity of their illness.