Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 380,000 new cases of bladder cancer (BC) occur around the world each year (Van Rhijn et al, Cytology and Urinary Markers for the Diagnosis of Bladder Cancer European Urology Supplements 8 (2009), 536-541), of which 70,000 are in the US. BC is the fourth most common cancer in men and eighth most common cancer in women. The worldwide age standardized incidence rate (ASR) is 10.1 per 100,000 for males and 2.5 per 100,000 for females.
Lifelong surveillance is required for bladder cancer patients who are initially diagnosed with noninvasive disease. In Europe, current patient monitoring protocols generally consist of regularly scheduled urethro-cystoscopy (UCS) as the gold standard and urine cytology as an adjunct. For the urological practice, in terms of cost reduction and convenience for patients, markers to detect recurrent disease would be particularly useful. Unfortunately, molecular urinary markers have not yet improved the combination of UCS and cytology with relation to detection of bladder tumors.
In the U.S., urine-based tests, particularly for low-grade lesions, have been developed for the detection and surveillance of urothelial carcinoma molecular markers on exfoliated cells in voided urine and are used in conjunction with urine cytology. The most prominent molecular markers include BTA Stat™ (Polymedco, Inc.), uCyt™/ImmunoCyt™ (Scimedx Corp.), and NMP22™ (Alere). The UroVysion™ DNA-FISH test (Abbott Molecular, IL) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) (see U.S. Pat. Nos. 6,174,681, 6,376,188, 7,232,655, and 7,998,670).
There remains a need for improved non-invasive bladder cancer tests.