Surveillance for recurrent bladder cancer using Oncuria-Monitor, a urine-based multiplex immunoassay

Introduction - Over 50% of patients with non-muscle invasive bladder cancer (NMIBC) will have a recurrence, necessitating a rigorous surveillance schedule. As urinary cytology's performance is poor, cystoscopy is standard of care in surveilling these patients. Oncuria-Monitor, a liquid biopsy to detect recurrent bladder cancer from a single voided urine sample demonstrated favorable performance. Methods- To investigate whether Oncuria-Monitor, a multiplex immunoassay that detects a bladder cancer associated diagnostic signature composed of 10 proteins in voided urine could improve bladder cancer detection while surveilling patients with a history of bladder cancer. From February 2017 through August 2020, 7 academic, private practice, and hospital facilities in the US and Japan prospectively enrolled 300 consecutive patients with a history of bladder cancer into this longitudinal study, which followed patients for two years. Diagnosis of bladder cancer recurrence, based on cystoscopy with biopsy, was accepted as the reference standard. At each cystoscopic clinic visit during the two years, patients provided a urine sample for analysis of Oncuria-Monitor (analyzed in a blinded manner), BladderChek and urine cytology. The performance of Oncuria-Monitor was compared with BladderChek and urine cytology as an aid to cystoscopy to detect recurrent bladder cancer. Results - Recurrent bladder cancer was diagnosed in 93 of the 300 patients (31%) by histopathological evaluation. Oncuria-Monitor detected 61 of 92 cancers with a sensitivity 74.2% (95% CI, 67.5-81.8%), specificity of 39.2% (95% CI, 34.6-43.1%) and negative predictive value (NPV) of 73.9% (95% CI, 68.6-79.9%), while sensitivity, specificity and NPV of BladderChek were 12.9%% (95% CI, 7.9-17.8%), 99.1% (95% CI, 98.1-99.8%) and 66.1% (95% CI, 63.9%-70.8%), respectively and sensitivity, specificity and NPV of urinary cytology were 28.8% (95% CI, 21.1-36.7%), 97.0% (95% CI, 95.3-98.4%) and 71.1% (95% CI, 62.7%-83.8%), respectively. Conclusions - In this large prospective trial, Oncuria-Monitor, had a substantially superior sensitivity compared to both BladderChek and urinary cytology in detecting recurrent bladder cancers.