Bladder cancer is the 10th most common cancer worldwide. They pose a high risk of recurrence and progression, hence an effective diagnostic, therapeutic and surveillance protocol is warranted. This study evaluates the diagnostic performance of the mRNA-based biomarker test, CxBladder Monitor in comparison to urine cytology in detecting recurrent bladder cancer.

A total of 100 samples were collected and analysed over a 16-month period (August 2023 – December 2024). 12 samples were excluded due to shipment issue. Results were compared to urine cytology. All patients were subjected to flexible cystoscopy as well. Data was analysed using T-test to determine statistical significance.

CxBladder demonstrated a sensitivity of 100% and an NPV of 100%, indicating its strong ability to rule out cancer recurrence. However, its specificity was 35.2%, and PPV was 14.8%, suggesting a high false-positive rate. Comparatively, urine cytology exhibited a sensitivity of 63.6%, specificity of 71.4%, PPV of 24.1%, and NPV of 93.2%. Additionally, CxBladder monitor scores below 3.5 reported an NPV of 97% and sensitivity of 93%, reinforcing its reliability in identifying low-risk patients. The study also explored the relationship between CxBladder levels and tumor histology, stage, and grade. Its use was best described amongst those with carcinoma in-situ (p = 0.007), stage Ta (p= 0.01) and of low grade (p= 0.004).

These findings suggest that while CxBladder is highly sensitive and valuable for ruling out disease recurrence, its low specificity may necessitate supplementary confirmatory tests. Incorporating CxBladder into bladder cancer surveillance could reduce unnecessary invasive procedures while maintaining diagnostic accuracy, particularly for low-risk patients. Further studies are warranted to optimize its clinical application.