Urine‐Based Bladder Cancer Diagnostics: A Local Evaluation of Cxbladder and Review of the ANZ Landscape

ABSTRACT The high demand for cystoscopies performed for bladder cancer diagnosis or surveillance imposes a significant burden on regional centres with limited capacity. Cxbladder is a urinary biomarker test that estimates the likelihood of bladder cancer. International and Australian studies suggested its utility in excluding patients for bladder cancer, reducing unnecessary cystoscopies. We conducted a prospective observational study to validate the performance of Cxbladder Triage (CxT) and Cxbladder Monitor (CxM) in patients undergoing cystoscopies for haematuria workup or bladder cancer surveillance at a regional Australian centre. Patient demographics were retrieved from electronic records, and a single urine sample was collected and analysed. Diagnostic performance metrics including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. We also conducted a narrative review of the literature to examine the existing research efforts in Australia and New Zealand (ANZ) in the urinary‐based diagnostic space for bladder cancer. One hundred and fifty‐four patients were eligible for analysis. CxT demonstrated NPV 100% (95% CI 83.2−100) and sensitivity of 100% (95% CI 15.8−100) but low specificity (26%, 95% CI 16.6−37.2) and PPV (3.4%, 95% CI 0.4−11.7). Similarly, CxM had high NPV (96%, 95% CI 87.3−99.6), specificity (78.9%, 95% CI 67.0−87.9) and sensitivity (77.8%, 95% CI 40.0−97.2), but low PPV (33.3%, 95% CI 14.6−57.0). The narrative review showed that there have been extensive efforts within ANZ for the validation of Cxbladder, supporting its integration into clinical protocols. Cxbladder is useful to exclude bladder cancer as a cause of haematuria and reduces the need for diagnostic and surveillance cystoscopies. Future research should prioritise large multicentre trials, head‐to‐head biomarker comparisons and cost‐effectiveness assessments to facilitate integration into standard clinical practice in ANZ.