PredictSure-IBD (PredictImmune Limited) is a prognostic assay which predicts long-term disease outcomes in immune-mediated diseases such as Crohn's disease and ulcerative colitis. This can help to personalise medical treatment. The assay reports the risk of severe, relapsing disease in patients recently diagnosed with Crohn's disease or ulcerative colitis. This allows anti-tumour necrosis factor (TNF) treatment to be offered to those who will benefit the most and to be given early in the disease course when it is most effective. The assay needs 2.5 ml of whole blood which is processed in a reverse transcriptase polymerase chain reaction (RT-PCR). This gives a result within 48 hours. The test is run on a Roche LightCycler PCR platform. After measuring the expression of 17 genes, the company's algorithm produces a clinical outcome prediction (high or low risk) for severe, relapsing Crohn's disease or ulcerative colitis.
PredictSure-IBD is an assay designed to predict the prognosis for people recently diagnosed with Crohn's disease or ulcerative colitis. By identifying those whose disease is more likely to progress to severe and relapsing, PredictSure-IBD can allow more personalised and effective anti-TNF treatment to start sooner.
After initial diagnostic investigations and tests for inflammatory bowel disease (IBD), drug treatment is prescribed in a stepped approach. This depends on the efficacy of the treatment, tolerability of the side effects and the severity of the disease.
Severe, active Crohn's disease is defined as very poor general health and 1 or more of: weight loss, fever, severe pain in the abdomen, frequent bouts (3 or more per day) of diarrhoea. If this does not respond to steroids and immunosuppressive drugs, the biological TNF inhibitors infliximab or adalimumab can be offered. Surgery can also be considered. Infliximab is an option for adults, children and young people aged 6 and over, but adalimumab is an option for adults only. Both drugs can be used with an immunosuppressive drug. NICE guidance also recommends vedolizumab after TNF inhibitors have not responded.
Severe ulcerative colitis is defined as 6 or more bowel movements a day with visible blood, high temperature and heart rate and anaemia. It is treated first with intravenous corticosteroids or intravenous ciclosporin for people who cannot tolerate, or decline, corticosteroids. Some people might also need surgery. If there is no improvement after 72 hours, corticosteroids and ciclosporin can be given together or surgery can be reconsidered. Infliximab can also be prescribed to people who cannot tolerate ciclosporin.
The PredictSure-IBD test would identify people for early treatment with TNF inhibitors. However, TNF inhibitors are not currently recommended by NICE for first-line treatment of Crohn's disease.
PredictSure-IBD is for use in people with Crohn's disease or ulcerative colitis before drug therapy has been started. The test would usually be done in an outpatient gastroenterology clinic and could also be used during a flare of disease for inpatients. It needs a 2.5 ml whole blood sample to be taken by a trained professional (such as a phlebotomist, nurse or doctor). The sample is then processed by a centralised laboratory facility in Cambridge, and the result returned to a specialist gastroenterologist within 7 days.
No additional staff training is needed to do the test, which is on an industry standard LightCycler RT-PCR system.
Currently in the NHS, no testing is offered to personalise the treatment of IBD. Current practice involves titrating and increasing drug treatment from steroids to immunosuppressives. Biological therapies are used on a 'step-up' and trial and error basis. In 2012, NICE estimated this to cost £31,000 per person over 5 years because of the costs of treatment, maintenance therapies, and managing complications associated with the disease and treatment.
The cost of introducing PredictSure-IBD to the treatment pathway could lead to substantial cost savings overall. This is if starting anti-TNF treatment earlier leads to reductions in disease flare-ups, use of maintenance therapy, surgery, disease complications and treatment complications.
The resource consequences of introducing the technology are low because the test uses existing technology and takes 2.5 days to return a result. It is expected that a batch of tests will be done once a week, meaning results will be returned in 7 to 10 days. This fits within the current NHS approach to treatment.
The company have done market research with 50 NHS consultants to find out their views on using different treatments and approaches. Of the consultants questioned, 98% agreed there was a need for an assay to predict clinical outcome, and all consultants said they would be likely to use such a test. These consultants were treating at least 15 patients with Crohn's disease per week.