Bladder Cancer by FISH

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 test. In this circumstance, additional clinical studies to exclude urothelial carcinoma should be pursued, as clinically indicated. Although this test was designed to detect genetic abnormality associated with most urothelial cancers, there will be some urothelial cancers whose genetic changes cannot be detected by this test.

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 probes were used to detect aneuploidy for chromosomes 3, 7, 17, and/or loss of 9p21 locus via fluorescence in situ hybridization (FISH). Results from this test are intended for use in conjunction with, and not in lieu of, current standard diagnostic procedures, as an aid for initial diagnosis of urothelial carcinoma and for monitoring for tumor recurrence in conjunction with cystoscopy in patients with previously diagnosed bladder cancer.