Diagnostic performance of Uromonitor and TERTpm ddPCR urine tests for the non-invasive detection of bladder cancer

Uromonitor and urinary telomerase reverse transcriptase promoter mutation droplet digital PCR (uTERTpm ddPCR) are non-invasive tests designed to detect bladder cancer in urine. We aimed to compare the diagnostic performance of uTERTpm ddPCR, Uromonitor and urine cytology in detecting bladder cancer. Urine samples were collected prospectively from patients diagnosed with primary (n = 74) and recurrent bladder cancer (n = 20) or benign urological conditions (n = 48) prior to surgical resection. The samples were tested for bladder cancer via uTERTpm ddPCR, Uromonitor and urine cytology. The sensitivity, specificity, and predictive values were calculated for each test, including confidence intervals. The results were stratified by low-grade non-muscle-invasive bladder cancer, high-grade non-muscle-invasive bladder cancer and muscle-invasive bladder cancer. Compared with urine cytology (59.5%, p = 0.005) and Uromonitor (56.8%, p = 0.001), the uTERTpm ddPCR test had the highest sensitivity (79.7%) for the detection of primary bladder cancer. Specificity did not significantly differ. The uTERTpm ddPCR test exhibited superior diagnostic performance over urine cytology and Uromonitor, highlighting its potential for non-invasive primary bladder cancer diagnosis.