UroVysion FISH

Negative: Negative results indicate a lack of evidence for the presence of numeric chromosomal abnormalities commonly associated with urothelial carcinoma, within the cells collected in this specimen. Negative results in the presence of other symptoms/signs of urothelial carcinoma may suggest the possibility of a false-negative result. In this circumstance, additional clinical studies to exclude urothelial carcinoma should be pursued as clinically indicated. Although the UroVysion Kit was designed to detect genetic abnormality associated with most urothelial cancers, there will be some urothelial cancers for which genetic changes cannot be detected by the UroVysion Test.

Positive: Positive results indicate the presence of one or more numeric chromosomal abnormalities commonly associated with urothelial carcinoma, within the cells collected in this specimen. Positive results in the absence of clinical documentation of urothelial carcinoma within the bladder suggest the possibility of urothelial carcinoma or other urologic malignancy from another site (including ureter, kidney, urethra, and prostate). In this circumstance, further clinical evaluation to exclude these as a source of the abnormal cells is justified.

The UroVysion Bladder Cancer Kit (UroVysion Kit) is approved for use by the U.S. Food and Drug Administration.