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Press Release

The BTA stat® test is a one-step device that detects recurrent bladder cancer from five drops of voided urine.

Cortlandt Manor, NY - February 18, 1998 The BTA stat® test is a new technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine. It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen 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 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.

Bladder cancer is the fourth most common cancer among men and ninth most common among women. It recurs in over 50% of patients, calling for regular testing and lifelong management. The current standard urine test is cytology, which detects cancer cells shed into the urine. However, cancer cells are not consistently present in samples, or cannot be preserved, leading to poor detection rates especially for early stage and grade disease.

 

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