Clinical data

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

  1. Blinded prospective study
  2. Including patients presenting with haematuria and/or lower urinary tract symptoms
  3. ADXBLADDER vs Cystoscopy, imaging and biopsy results
  4. Carried out at 7 leading UK Centres
  5. 856 patients recruited
  6. 578 patients interim analysis results as follows (total patients cohort analysis currently under peer review for publication):  

95% Sensitivity in High Risk Bladder Cancers

NPV of 97%

Upper Tract Sensitivity 80%

Such as High Risk Non-Muscle Invasive Bladder Cancers (NMIBC)  and Muscle Invasive Bladder Cancer (MIBC)
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 for monitoring the recurrence  of NMIBC 

  1. Blinded prospective study
  2. Including patients in the first 2 years of follow up after a primary or recurrent bladder tumour
  3. ADXBLADDER vs Cystoscopy, Cytology and Pathology
  4. Carried out at 21 leading European Centres
  5. 2000 patients recruitment target
  6. Study currently ongoing: 469 patients interim analysis results as follows:

80% Sensitivity for non-Low Grade-pTa tumours

NPV of 99% for non-Low Grade pTa tumours