How do results with the UroVysion Kit compare with those of conventional urine cytology tests?
The UroVysion Kit looks for abnormalities in chromosomal DNA that can occur independent of significant changes in cell morphology; this makes it more sensitive than conventional urine cytology. Both tests look for stray cancer cells that have been shed into the urine, but the UroVysion Kit is able to identify potential cancer cells by their DNA content. The following data tables from the Clinical Trials for the UroVysion Kit compare its sensitivity to urine cytology sensitivity for various stages and grades of bladder cancer (Tables 1 and 2): Table 1. Sensitivity (%) by Stage Stage UroVysion Kit Urine cytology TaG1 55% 20% TaG2,3 83% 33% T1 83% 67% T2 100% 33% Tis 100% 33% Table 2. Sensitivity (%) by Grade Grade UroVysion Kit Urine cytology 1 55% 18% 2 78% 44% 3 94% 41% High sensitivity translates into few false negatives. Specificity of traditional cytology and the UroVysion Kit are both ~95% among healthy and non-healthy test subjects. This translates into few false positives. High s
