• The technology described in this briefing is PredictSure-IBD. It is used as a prognostic tool to identify patients who will go on to have severe, relapsing Crohn's disease and ulcerative colitis and who might benefit from early aggressive (biological) therapy.

  • The innovative aspect is that it is designed to predict clinical prognosis when Crohn's disease or ulcerative colitis are diagnosed, using a combination of existing assays based on polymerase chain reaction technology.

  • The intended place in therapy would be to help the gastroenterologist's choice of treatment for people who have been recently diagnosed with Crohn's disease or ulcerative colitis.

  • The main points from the evidence summarised in this briefing are from 2 biochemical studies and 1 prospective cohort study with 248 adult patients in a UK NHS secondary care outpatient setting. They show that PredictSure-IBD can accurately show which patients are likely to have severe relapsing disease. Evidence suggests an improved disease response when treatment with tumour necrosis factor (TNF) inhibitors is started early.

  • Key uncertainties around the evidence or technology are that the test has only been validated in biochemical studies.

  • The cost of PredictSure-IBD is £1,250 per unit (exclusive of VAT). The resource impact could be much lower than the current standard of care if starting anti-TNF therapy early leads to disease remission and prevents disease flare-ups but this is uncertain because it depends on the positive predictive value of the test, which is not yet determined.