A Multigene Urine Test for the Detection and Stratification of Bladder Cancer in Patients Presenting with Hematuria

Purpose: We investigated whether the RNA assay uRNA® and its derivative Cxbladder® have greater sensitivity for the detection of bladder cancer than cytology, NMP22™ BladderChek™ and NMP22™ ELISA, and whether they are useful in risk stratification.Materials and Methods: A total of 485 patients presenting with gross hematuria but without a history of urothelial cancer were recruited prospectively from 11 urology clinics in Australasia. Voided urine samples were obtained before cystoscopy. The sensitivity and specificity of the RNA tests were compared to cytology and the NMP22 assays using cystoscopy as the reference. The ability of Cxbladder to distinguish between low grade, stage Ta urothelial carcinoma and more advanced urothelial carcinoma was also determined.Results: uRNA detected 41 of 66 urothelial carcinoma cases (62.1% sensitivity, 95% CI 49.3–73.8) compared with NMP22 ELISA (50.0%, 95% CI 37.4–62.6), BladderChek (37.9%, 95% CI 26.2–50.7) and cytology (56.1%, 95% CI 43.8–68.3). Cxbladder, which was...