Clinical data

ADXBLADDER Performance Evaluation for diagnosis of bladder cancer in patients with haematuria 1

  • Blinded prospective study
  • Including patients presenting with haematuria and/or lower urinary tract symptoms
  • ADXBLADDER vs Cystoscopy, imaging and biopsy results
  • Carried out at 7 leading UK Centres
  • 856 patients recruited

Sensitivity
(excl. LGpTa)
85%

Excluding Low Grade pTa tumours

NPV
(excl. LGpTa)
98.7%

Upper Tract
Sensitivity
80%

80% sensitivity for Upper Tract Transitional Cell Carcinomas (TCCs) such as those of the Ureters and Kidney,
which can be difficult to detect with cystoscopy or ultrasound.


ADXBLADDER Performance Evaluation in bladder cancer follow-up

  • Blinded prospective study
  • Including patients in the first 2 years of follow up after a primary or recurrent bladder tumour
  • ADXBLADDER vs Cystoscopy, Cytology and Pathology
  • Carried out at 21 leading European Centres
  • 2000 patients recruitment target
  • Study closed at the end of July 2019. Data referred to interim analysis of 1192 pts
  • 362 samples had matching Cytology data
  • 39 were positive for bladder cancer recurrence (9 were non-LGpTa Recurrences)

ADXBLADDER clinical performance

Sensitivity
(excl LGpTa)
84%

NPV
(excl. LGpTa)
99.5%

ADXBLADDER performance vs cytology

Excl LGpTa tumours

All tumours

References

  1. Dudderidge T, et al. A Novel, non-invasive Test Enabling Bladder Cancer Detection in Urine Sediment of Patients Presenting with Haematuria—A Prospective Multicentre Performance Evaluation of ADXBLADDER. Eur Urol Oncol (2019), https://doi.org/10.1016/j.euo.2019.06.006