Multicenter prospective study of urinary DNA methylation test for early bladder cancer diagnosis

An accurate noninvasive biomarker test is needed for the early diagnosis of bladder cancer. A prospective study at ten centers in South Korea, included individuals 40 years and older with hematuria undergoing cystoscopy within 3 montsh after inclusion. Among the 1099 participants, 219 had bladder cancer and 176 had high-grade or invasive bladder cancer. A urinary DNA methylation test showed 89.2% sensitivity and 87.8% specificity in the detection of high-grade or invasive bladder cancer, and 78.1% sensitivity and 88.8% specificity in the detection of overall bladder cancer. In comparison with nuclear matrix protein 22 and urine cytology test, the urinary DNA methylation test showed superior sensitivity for high-grade or invasive bladder cancer. The authors conclude that these results suggest that among individuals with hematuria, a urinary DNA methylation test outperformes NMP22 and urine cytology tests for detection of high-grade or invasive bladder cancer.