What is UroVysion®?

The UroVysion® test uses fluorescence in situ hybridization (FISH) assays on voided urine specimens fixed on microscope slides. FISH is a type of hybridization in which a DNA "probe" is labeled with fluorescent molecules so that it can be seen with a microscope. The term "in situ" means that the hybridization occurs "in place," in this case, within the nucleus of specimen cells that have been fixed to a microscope slide. The UroVysion® test consists of a four-color, four-probe mixture of DNA probe sequences homologous to specific regions on chromosomes 3, 7, 9, and 17. This UroVysion™ kit is designed for the detection and quantification of chromosomes 3, 7, and 17, and the 9p21 locus in human urine specimens by FISH. UroVysion® is the first genetic test approved by the FDA for both the diagnosis and monitoring of bladder cancer recurrence in conjunction with cystoscopy. Cystoscopy is a procedure used by urologists to examine the bladder wall with a cystoscope, a slender fiber optic tube with a light and lens. During the cystocopy procedure the urologist may take a small piece of tissue known as a biopsy specimen.

Why do I need UroVysion®?

There are approximately 57,000 new cases and 12,500 deaths from bladder cancer each year in the United States. Cystoscopy and cytology are currently the primary modalities used to detect and monitor urothelial carcinoma. Urinary cytology is the microscopic analysis of cells collected from a urine sample. However, cytology has relatively poor sensitivity for the detection of bladder cancer. The poor sensitivity of cytology and extensive training required to interpret urine cytology have led to the development of numerous tests for the detection of urothelial carcinoma in urine. FISH has a significantly higher sensitivity than cytology (81% vs. 58%) for the detection of bladder cancer, and clarifies cases in which the cystoscopy or cytology results are equivocal or suspicious (see table). The UroVysion® performed extremely well in patients receiving BCG intravesical treatment. Test result agreement with gold standard cystoscopy/histology was 92%, indicating that the test results are unaffected by BCG-treatment.

One bladder cancer cell showing increased copy numbers for chromosomes 3 (4 red dots) and 7 (4 green dots).

One benign urothelium on the right with a normal chromosomal pattern (2 red dots for chromosome 3, 2 green dots for chromosome 7). One bladder cancer cell on the left with gain of chromosomes 3 (5 red dots) and 7 (4 green dots).p>

Table: Sensitivity and Specificity of Cytology and FISH*

What does my UroVysion® result mean?

Results from the Vysis® UroVysion® Bladder Cancer Recurrence™ kit (UroVysion®) are intended for use as a non-invasive method for monitoring tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. If your urine specimen is positive for UroVysion® testing, a cystoscopy and/or bladder biopsy procedure might be needed. Your doctor will discuss with you the next steps to take.

1. Halling KC, King W, Sokolova IA, et al. A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. J Urol. 2000 Nov;164(5):1768-75.
2. Halling KC, King W, Sokolova IA, et al. A comparison of BTA stat, hemoglobin dipstick, telomerase and Vysis UroVysion assays for the detection of urothelial carcinoma in urine. J Urol. 2002 May;167(5):2001-6.
3. Varella-Garcia M, Akduman B, Sunpaweravong P, et al. The UroVysion fluorescence in situ hybridization assay is an effective tool for monitoring recurrence of bladder cancer. Urol Oncol. 2004 Jan-Feb;22(1):16-9.
4. Kipp BR, Karnes RJ, Brankley SM, et al. Monitoring intravesical therapy for superficial bladder cancer using fluorescence in situ hybridization. J Urol. 2005 Feb;173(2):401-4.