Point-of-Care Test Detects Recurrent Bladder Cancer

A point-of-care technology for the early detection of recurrent bladder cancer uses monoclonal antibodies to detect the presence of bladder tumor-associated antigen in urine.

The test is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen (BTA) in voided urine. The specificity of the BTA stat test was 93-95% in patients with non-genitourinary diseases and cancers, and healthy individuals tested as part of a multi-center study. The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early stage and grade cancers that cytology often misses. Requiring five drops of urine, the result is delivered in only five minutes. The appearance of a line in the patient window indicates a positive result. The BTA stat test requires one voided urine sample with no sample preparation.

The bladder tumor-associated antigen has been shown to be produced by bladder tumor cells in cell culture and shed into the urine of bladder cancer patients, where it can be detected using the BTA stat test and/or BTA Trak assay. It has also been shown to be produced by bladder tumor cells using in situ hybridization. In addition, cultured cells, including bladder cancer cells, have been shown to be significantly more susceptible to lysis by complement in the presence of specific monoclonal antibodies.

Bladder cancer is the fourth most common cancer among men and tenth among females. It has a five-year survival rate of 94% if caught early, and recurs in over 88% of patients within 15 years, calling for regular testing and lifelong management.

The BTA stat test is a product of Polymedco, Inc. (Cortland Manor, NY, USA).


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