Advice

Summary

Summary

  • The technology described in this briefing is Bladder EpiCheck. It is used for detecting recurrence in people who are having surveillance after treatment for non-muscle-invasive bladder cancer.

  • The innovative aspects are that it provides a non-invasive method for detecting cancer recurrence. The test provides an objective result based on the methylation patterns of 15 biomarkers and uses standard laboratory equipment.

  • The intended place in therapy would be as well as or instead of cystoscopy, and instead of cytology or other urine biomarker tests in people having surveillance for non-muscle-invasive bladder cancer.

  • The main points from the evidence summarised in this briefing are from 1 systematic review and network meta-analysis, 3 prospective cohort studies and 1 retrospective cohort study of 3,064 people having surveillance after treatment for non-muscle-invasive bladder cancer. The systematic review and meta-analysis reported pooled overall results as follows: a sensitivity of 74%, a specificity of 84%, a positive predictive value of 48% and a negative predictive value of 94%. In high-grade cancer, these results were 91%, 81%, 43% and 98%, respectively.

  • Key uncertainties around the evidence or technology are that some of the available evidence is from studies with a relatively small sample size and short follow-up duration. There is currently no published evidence in an NHS setting.

  • Experts advised that the technology is not yet widely used in the NHS, but aside from cost, they were not aware of any major barriers to adoption. The main potential benefit identified by the experts was fewer repeat cystoscopies in some people. Two out of 5 experts felt uncertain about the efficacy of the test and its advantages over other biomarker tests already available.

  • The cost of Bladder EpiCheck is £300 per test (excluding VAT). The cost of standard care is around £240 per test for cystoscopy and around £3 per test for cytology.