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Urine cytology and urine-based markers for bladder urothelial carcinoma detection and monitoring: developments and future prospects.

Bladder cancer is currently diagnosed using cystoscopy and cytology in patients with suspicious signs and symptoms. These tests are also used to monitor patients with a history of bladder cancer. The recurrence rate for bladder cancer is high, thus necessitating long-term follow-up. Urine cytology has a high sensitivity and specificity for the detection of high-grade urothelial carcinoma, but lacks the sensitivity to detect low-grade tumors. Recently, multiple noninvasive urine-based bladder cancer tests have been developed. Many markers (BTA stat((R)), BTA TRAK((R)), ImmunoCyt, NMP22((R)) and UroVysion) have already been approved by the US FDA for bladder cancer surveillance, while other markers are still undergoing development, preclinical and clinical investigation. An ideal bladder cancer test would be noninvasive, highly sensitive and specific, inexpensive, easy to perform and yield highly reproducible results. Many of the tests reviewed herein meet some, but not all, of these criteria.