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The following is a summary of “Uromonitor: Clinical Validation and Performance Assessment of a Urinary Biomarker Within the Surveillance of Patients With Nonmuscle-Invasive Bladder Cancer,” published in the March 2025 issue of Journal of Pediatrics and Child Health by Ramos et al.
Noninvasive and cost-effective alternatives to current standard-of-care (SOC) procedures in standard nonmuscle-invasive bladder cancer (NMIBC) follow-up is needed. Uromonitor detects bladder cancer (BC) recurrence by screening TERT, FGFR3, and KRAS mutations.
Researchers conducted a retrospective study to assess Uromonitor’s performance against standard methods.
They enrolled 439 patients with 528 NMIBC surveillance. They performed SOC methods, collected urine samples for Uromonitor, and conducted cystoscopy. They calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for recurrence and compared results with cystoscopy plus transurethral resection histopathology.
The results showed that Uromonitor had 87% sensitivity (95% CI, 74-95), 99% specificity (98-100), 93% PPV (82-98), and 99% NPV (97-99). About 6 of 47 recurrences were missed, and Uromonitor had three false positives, while cystoscopy had 22 (32%). The overall recurrence rate was 8.9% (n = 47) among 528 screenings. Sensitivity, specificity, PPV, and NPV remained high across all NMIBC grades and stages.
Investigators validated Uromonitor as a reliable tool for detecting NMIBC recurrence across all stages and grades. They confirmed its clinical usefulness in the largest single-center study.
Source: auajournals.org/doi/10.1097/JU.0000000000004335
