Advice

Summary

Summary

  • The technology described in this briefing is ADXBLADDER. It is used to detect bladder cancer in people with symptoms associated with malignancy and to monitor for recurrence within the urogenital tract during follow-up after transurethral resection of a bladder tumour.

  • The innovative aspect is that it detects bladder cancer based on the novel biomarker, minichromosome maintenance complex component 5 (MCM5).

  • The intended place in therapy would be alongside cystoscopy but as an alternative to other urine-based tests.

  • The main points from the evidence summarised in this briefing are from 1 multicentre prospective study including a total of 577 people presenting with haematuria or lower urinary tract symptoms, with suspected malignancy. It shows that ADXBLADDER can detect bladder cancer with 76% sensitivity and 69% specificity.

  • Key uncertainties around the evidence are that it is limited to 1 study, with data published in abstract form only. Further studies are needed to validate results when the test is used to help initial diagnosis and provide evidence for the test when it is used to monitor for recurrence. Longer-term data and comparative data to other urinary biomarker tests would be helpful.

  • The cost of ADXBLADDER is £52 (excluding VAT) per test.