UroVysion® FISH

The assay 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 subjects with transitional cell carcinoma of the bladder. This assay does not detect other chromosomal or genetic alterations. Results are intended for use as a noninvasive method of monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The clinical interpretation of test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results.

Specimens should be received at the laboratory within 72 hours postcollection for optimal testing. Specimens older than 72 hours will not be rejected; however, results not guaranteed. In these instances, clients should consider recollection if possible.

Positive FISH results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract-related cancers (eg, ureter, urethra, renal, and/or prostate in males), and further patient follow-up may be helpful. Negative FISH results in the presence of other signs and symptoms of bladder cancer recurrence may need to be regarded as suspicious false-negative results; repeat testing may be indicated. Although the assay was designed to detect chromosome changes associated with most bladder cancers, there are some bladder cancers whose genetic changes are not targeted by this test.

Fluorescence in situ hybridization (including diagnostic interpretation by MD pathologist)