Clinical Validation

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Published Data for
PredictSURE® IBD

The IBD biomarker was originally discovered using gene expression analysis of CD8+ T cells (Lee 2011, McKinney 2015) and subsequently translated into a 17 gene (15 informative, 2 control genes) whole blood qPCR test, validated on an independent cohort of 123 IBD patients (66 CD, 57 UC) (Biasci 2019).

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Patients identified as high-risk experienced a more aggressive disease course characterised by:

  • Shorter time to treatment escalation; hazard ratio (HR) 2.65 for CD and 3.12 for UC (Fig. 1 A,B)
  • Increased risk of any treatment escalation; relative risk (RR) at 12 months 1.7 for CD, 2.8 for UC (Fig. 1 C,D)
  • Increased risk of multiple treatment escalation

  • Need for more potent therapies to achieve disease remission

    Figure 1 (A,B) Treatment-free survival for Crohn’s disease and ulcerative colitis; P= log-rank test. HR: hazard ratio. (C,D) Stacked density plots demonstrating maximum medical therapy required over 2.5 years follow up in high and low-risk sub-groups for CD and UC. Data censored at maximum follow-up for each patient (Biasci 2019).

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PredictSURE IBD test clinical validation

Results based on validation in a cohort of patients independent from the discovery cohort

1. PredictSURE IBD Clinical Validation (PredictSURE IBD IFU, see Biasci et al. 2019 for longer term follow up)
*in the first 12 months of follow up

PredictSURE IBD validation study –

A blood-based prognostic biomarker in IBD