Bladder cancer detection with urinary survivin, an inhibitor of apoptosis.

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. By looking to the pathophysiology of bladder cancer, we identified survivin, an inhibitor of apoptosis that is not generally expressed in fully differentiated adult tissue and is highly expressed in bladder cancer. Survivin is detected in whole urine of patients with TCC using a simple antibody based test. The sensitivity of survivin testing for new or recurrent bladder cancer is 100% while the specificity for other neoplastic and non-neoplastic genitourinary disease is 95%. The high sensitivity of this simple, noninvasive test is well suited to bladder cancer, a disease with high rates of recurrence.