Clinical Validation of a Multiplex Urine Biomarker Assay for Surveillance of Recurrent Bladder Cancer

BACKGROUND: More than 50% of patients with non-muscle invasive bladder cancer (NMIBC) experience recurrence, requiring lifelong surveillance with repeated cystoscopy. Given the invasive nature and cost of cystoscopy, accurate non-invasive tools are needed to support risk-adapted monitoring. We evaluated the ability of Oncuria-Monitor to detect recurrent bladder cancer (BC) during surveillance. METHODS: Between February 2017 and August 2020, six medical centers in the United States and Japan prospectively enrolled 300 patients with a history of BC, generating 1,248 serial urine samples. Participants were divided into training and validation cohorts. At each surveillance visit over two years, urine samples were analyzed in a blinded manner using Oncuria-Monitor and BladderChek™, alongside urine cytology. Test performance was compared with cystoscopy and histopathology-confirmed recurrence. RESULTS: Recurrent BC was identified in 31% (93/300) of participants, with 143 total recurrences during follow-up, including 90 tumors in the validation cohort. In the validation cohort, Oncuria-Monitor achieved a sensitivity of 85.6% (95% CI: 78.1-92.2%) and negative predictive value (NPV) of 93.0% (95% CI: 89.2-96.4%). In comparison, BladderChek™ demonstrated a sensitivity of 20.0% and NPV of 88.0%, while urine cytology showed a sensitivity of 36.9% and NPV of 91.6%. The number needed to evaluate to detect one recurrence was 3 for both cystoscopy and Oncuria-Monitor, compared with 15 for BladderChek™ and 8 for cytology. CONCLUSIONS: In this prospective study, Oncuria-Monitor demonstrated clinically actionable performance, enabling a rule-out strategy that could safely reduce cystoscopy in approximately 25% of surveillance visits. These findings support a paradigm shift toward biomarker-guided, risk-adapted surveillance in BC.