For Clinicians
Understanding
Why you should use PredictSURE® IBD
Adapted from Colombel et al
Click image to enlarge
Without a prognostic test that stratifies patients based on risk, the standard of care is often a one-size fits all step-up approach. This may result in patients experiencing multiple flares causing bowel damage that can lead to disability and require surgical intervention (Figure A).
Controlling inflammation early can increase the chance of patients achieving long term remission, reducing flares, bowel damage and the need for surgery (Colombel, J-F et al 2017) (Figure B)
Using PredictSURE IBD allows you to identify patients at high-risk of early and frequent relapses, enabling you to optimise treatment strategy for each patient. You might choose the early use of aggressive therapy for patients at high-risk of frequent and early relapses, to maximise the chance of achieving remission and reducing the need for surgery in the long-term.
See our latest long-term validation data to see how PredictSURE IBD can help you identify high-risk patients.
External Reviews
“The results of this test could mean patients having the right treatment at the right time and that is invaluable to the health of the patients”
Patient reviewer from NIHR DEC
PredictSURE IBD has been positively reviewed by a number of influential healthcare organisations:
- NIHR Diagnostic Evidence Co-operative 2015 – “very interesting and relevant technology” underpinned by “robust evidence base”
- NICE Medtech Innovation Briefing (MIB) 2019 – found PredictSURE IBD could accurately show which patients are likely to have severe relapsing disease. Expert and patient advocacy reviewers agreed the test could deliver benefits for patients.
- PredictSURE IBD is currently being evaluated by NICE Diagnostic Assessment Programme (DAP), with a decision due 2021.
Health Economic Impact
PredictImmune commissioned a health economic study to evaluate the economic impact of PredictSURE IBD on the UK Healthcare system. The model concluded that over the modelled period (20 years), the test delivered improved outcomes for both Crohn’s disease and ulcerative colitis with strong incremental cost-effectiveness ratio (ICER) for Crohn’s disease and potential cost savings for ulcerative colitis. More information in 2020 ECCO conference poster.
Health Economic Study Impacts
Patient benefits - improved quality of life, reduced complications
Cost saving for ulcerative colitis over 20 years
Strong ICER for Crohn's disease at 20 years
Cost savings may be greater over the long term
help and support
Frequently asked questions
What is PredictSURE® IBD?
PredictSURE IBD is a prognostic blood test for adults (16 years and older) with either Crohn’s disease or ulcerative colitis, including newly diagnosed patients. The test uses RNA from whole blood to generate gene expression data that stratifies patients into high- and low-risk sub-groups, which reflect the likelihood of them experiencing a frequently relapsing disease course.
How is a result from PredictSURE® IBD different to markers of disease activity i.e. CRP, calprotectin?
Unlike markers of disease activity such as CRP (C-reactive protein) and faecal calprotectin, PredictSURE IBD predicts patient outcome. Disease activity information provided by biomarkers such as CRP and calprotectin is not a good predictor of patient outcomes. PredictSURE IBD stratifies patients into those at high- or low-risk of frequent relapses in the future but does not provide information about current disease activity.
How does PredictSURE® IBD work?
PredictSURE® IBD is a RT-qPCR test that uses RNA extracted from whole blood samples to generate gene expression data, which is processed using a unique and proprietary software algorithm to stratify Crohn’s disease and ulcerative colitis patients based on their risk of severe relapsing disease.
Does PredictSURE® IBD diagnose IBD?
No. PredictSURE IBD does not provide any information regarding patients’ diagnosis, only their prognosis.
How do I order PredictSURE® IBD?
You can order tests from one of our clinical lab partners.
What does high- and low-risk mean?
Patients in the high-risk group are more likely to experience aggressive disease, characterised by shorter time to first treatment escalation, and an increased risk of multiple treatment escalations. Conversely, low-risk patients typically experience milder disease, characterised by longer time to first treatment escalation and fewer treatment escalations.
Which patients are eligible for testing?
PredictSURE IBD can be used at diagnosis and is intended for use in patients who meet the following criteria:
- Adult (16+ years)
- Active disease, not on immunosuppressive therapy
Take a look at our Patient Selection and Sample Collection guidelines for more information.
My patient has received immunosuppressive therapy previously, can they have the test?
Patients who have had treatment for previous episodes of active disease can also be tested as long as they are in active flare and not on immunosuppressive therapy.
Is this test more effective than my own criteria for stratifying patients?
PredictSURE IBD has been shown to be more effective than existing clinical risk factors at predicting outcomes for Crohn’s and ulcerative colitis patients (for more information see Biasci et al. 2019).
How do I collect blood samples?
Whole blood samples are collected directly into PAXgene® Blood RNA tubes and sent to our partner labs for RNA extraction and analysis. Please read our sample collection guidelines for more information.
Where do I send samples?
Tests are supplied by our clinical lab partners. Blood samples need to be sent to the lab from whom you ordered the test. If you need more information you can find details for all our clinical lab partners here.
What are the results reports like?
You can download an example PredictSURE IBD results report here.
How do I get patient results?
Our clinical lab partners upload assay data to the PredictSURE IBD Web Portal, where a proprietary algorithm generates a results report with IBD low/high status for the clinician to share with their patients. If you are waiting for results, please contact the lab that supplied the test.
How long will it take to get the results from the test?
Test fulfilment is the responsibility of our partner labs, please confirm times with them directly. In general, once your sample arrives at the testing laboratory, it will take around 3-5 days to run the test and generate results. If you are waiting for results, please contact the lab that supplied the test.
How does the prognosis allow for better decision making?
Knowing the likely prognosis for a patient at the point of diagnosis helps you to choose the most appropriate treatment and to schedule follow up appointments and monitoring to identify potential flares as early as possible.
How does the test inform the clinical path?
PredictSURE IBD will not tell you what treatment to prescribe but guide your choice of treatment strategy; there is evidence that the early use of aggressive treatments such as biologics (“top-down” approach) and increased monitoring of patients at risk of active disease within the “window of opportunity” can enable tight control, sustained remission and better outcomes for IBD patients (Colombel et al., 2017).
Patients at lower risk of active disease can potentially benefit from a less aggressive standard of care as defined by a “step-up” approach to treatment. You might also choose to monitored low risk patients less frequently.
How has the test been validated/how was the signature discovered?
The initial signature was discovered by microarray analysis of the expression patterns in CD8+ T cells in a cohort of 32 AAV patients, with validation in an additional 27 AAV patients (McKinney et al., 2010).
A similar signature was subsequently discovered in IBD patients (Lee et al., Mckinney et al. 2015).
An RT-qPCR version of the test was subsequently developed and validated in an independent cohort of 123 IBD patients with median follow up of 18 months (Biasci et al, 2019).
What accreditation does the kit have?
The kit received CE marking in December 2018 which is required before any IVD test can be sold in Europe. The CE accreditation is a requirement that ensures the test complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and will enable PredictSURE IBD to be commercialized in the EU.
The test is available in a number of other countries via our regional laboratory partners. Please see our website for information about your local provider on our website.
What is the test’s clinical performance?
98% of patients identified as low risk did not have multiple treatment escalations in the first 12 months (NPV), whilst 91% of patients who required multiple treatment escalations were classified as high-risk (sensitivity). These performance characteristics are from the clinical validation for CE marking. For more information see PredictSURE IBD IFU and Biasci et al. 2019 for longer term follow up.
Has the test been reviewed by NICE?
PredictSURE IBD is currently being reviewed as part of NICE’s Diagnostic Assessment Programme (DAP) with guidance expected to be published towards the end of 2020 (https://www.nice.org.uk/guidance/indevelopment/gid-dg10029).
NICE has already released its MIB report (available here: https://www.nice.org.uk/advice/mib178).
Is the test reimbursed by insurers?
We are currently working with payers to cover this test. Where appropriate, our partner labs globally will submit all claims to insurers and patients for any co-pay responsibility.
What clinical trials have been conducted with PredictSURE® IBD?
The UK based PROFILE (Predicting Outcomes for Crohn’s disease using a molecular biomarker) trial seeks to demonstrate that the combination of risk-stratification of patients with Crohn’s disease with PredictSURE IBD followed by differential treatment based on the risk profile, results in better outcomes for patients, and that the test is predictive of those outcomes.
In the US, we are carrying out the PRECIOUS (Predicting Crohn’s and Colitis outcomes in the US) study, which is a multi-centre, observational study of patients with active Crohn’s disease (CD) or ulcerative colitis (UC), recruiting up to 200 patients from centres across the US. The study aims to assess whether a PredictSURE IBD can stratify IBD patients in the US according to their subsequent disease course. Patients will be followed up for up to 12 months following initial blood sample collection and be treated according to local practice.
What is the cost saving/impact of PredictSURE IBD?
PredictImmune commissioned a Health Economic analyisis by Cogentia Healthcare that looked at the Health Economic impact of the use of PredictSURE IBD inthe UK healthcare system. The model compared two scenarios – standard of care (step-up therapy for the majority of patients, consistent with NICE guidance) versus the use of PredictSURE IBD followed by step-up therapy for low-risk patients and top-down for high-risk patients. The results over a 15 year modelling period were:
- Improved outcomes for high-risk group with an associated cost per quality adjusted life years (QALY) of ~£7,200 Crohn’s disease – well below NICE’s threshold to reimburse. At 20 years, this falls to £2176.
- Improved outcomes for high-risk ulcerative colitis patients with an associated cost saving associated with a QALY of -£8,300.
Paul Lyons – VP Platform Delivery
Eoin McKinney – CSO
Andy Sandham, Chairman
