Polymedco, Inc, announced the availability of the BTA Stat test—a point of care 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% to 95% in patients with nongenitourinary diseases and cancers and healthy individuals tested in a multicenter study. The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early-stage and low-grade cancers that cytology often misses. Requiring only three drops of urine, the result is delivered in 5 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 test is clinical laboratory improvement amendments (CLIA) waived and also available for prescription home use.