Advice

The technology

The technology

PredictSURE IBD (PredictImmune) is a prognostic assay that predicts long-term disease outcomes in inflammatory bowel disease (IBD) such as ulcerative colitis. It stratifies people with IBD into a high or low risk of severe, relapsing inflammation of disease by detecting CD8+ (cluster of differentiation 8) T‑cell exhaustion. The level of gene expression indicating CD8+ T‑cell exhaustion is linked to disease course in multiple autoimmune diseases, including IBD. The test needs 2.5 ml of whole blood, which is processed in a reverse transcriptase polymerase chain reaction (RT‑PCR). 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 inflammation of ulcerative colitis.

Innovations

PredictSURE IBD is designed to help personalise treatment for people with ulcerative colitis. By identifying whose disease is more likely to progress to a severe and relapsing inflammation, it may allow more personalised treatment.

Current care pathway

After initial diagnostic investigations and tests for IBD, investigations should assess the level of disease activity and the risk of long-term complications.

Disease activity for ulcerative colitis can be assessed using the:

  • Simple Colitis Clinical Activity Index (SCCAI)

  • Ulcerative Colitis Disease Activity Index.

Ulcerative colitis should be managed differently depending on the severity of disease. For mild to moderative disease, a topical aminosalicylate is recommended as a first-line treatment. For severely active ulcerative colitis, biologics and Janus kinase inhibitors are recommended.

The following publications have been identified as relevant to this care pathway:

Population, setting and intended user

PredictSURE IBD is intended to be used in adults (16 years or older) with ulcerative colitis, who have active disease and are not receiving concomitant treatment such as steroids, immunomodulators or biologic therapies.

The test can be carried out in both inpatient and outpatient gastroenterology clinics and should only be used for people in an active flare of disease who are not on immunomodulatory medications. The blood sample needs 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 is returned to a specialist gastroenterologist normally within 7 days.

No additional staff training is needed to do the test, which is on an industry-standard LightCycler RT‑PCR system.

Costs

Technology costs

PredictSURE IBD was launched in February 2019 and has been available for research use as a testing service only. The cost of the technology is £1,250 per person.

Costs of standard care

There is no standard testing currently in the NHS to personalise ulcerative colitis treatment. 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.

Resource consequences

Introducing PredictSURE IBD to the treatment pathway could lead to cost savings if starting treatment earlier results in reductions in disease flare-ups, use of maintenance treatment, surgery, disease complications and treatment complications.

The resource consequences of introducing the technology are low because the test uses existing technology and takes 2 to 7 days. This fits within the current NHS approach to treatment.