The current "gold standard" for the diagnosis of bladder cancer is cystoscopy and urine cytology. Cystoscopy, a naked eye assessment of the bladder, is invasive, uncomfortable and costly while cytology has high specificity but low sensitivity (40-60%) particularly for low-grade lesions. Therefore, there is a need for a molecular tumor marker assay that is simple to perform and sensitive, particularly for low-grade lesions.
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