UROVYSION® BLADDER CANCER KIT
Intended Use: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use in conjunction with (and not in lieu of) current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
FOR IN VITRO DIAGNOSTIC USE
Can help detect chromosomal abnormalities associated with the development and progression of bladder cancer, even when cystoscopy is negative.
Delivers an overall specificity of 93%, as noted in assay package insert. However, if UroVysion results are negative but standard clinical or diagnostic tests (such as cytology or cystoscopy) are positive, the standard procedures take precedence over UroVysion. Although the UroVysion Kit was designed to detect genetic changes associated with most bladder cancers, there will be some bladder cancers whose genetic changes cannot be detected by the UroVysion test.
1 Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescencein situ hybridization for the detection of urothelial carcinoma. J Urol, 2000; 164; 1768-1775.