- Diagnose bladder cancer in patients with hematuria (in conjunction with standard diagnostic procedures)
- Detect bladder cancer recurrence
Bladder cancer is the fourth most common cancer in men and the ninth in women, with a combined estimate of 63,210 new cases in the U.S. in 2005.1 Non-invasive, superficial cancers can usually be cured, especially when well differentiated. Many bladder cancers, however, will recur: despite complete tumor resection, about 66% of patients will have a recurrence within 5 years and 88% within 15 years. Frequent monitoring (up to four times per year) for early detection of recurrence is key to increased survival of these patients. Traditionally, cystoscopy-guided biopsy, followed by histology, has been used for initial diagnosis, and cystoscopy and voided urine cytology (VUC) have been used for monitoring.
Vysis UroVysion is a molecular cytology test that detects aneuploidy of chromosomes 3, 7, and 17 and deletion of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens. In a study of 497 patients with hematuria, the Vysis UroVysion test showed a diagnostic sensitivity of 69% and specificity of 78% compared with cystoscopy followed by histology. The positive and negative predictive values were 27% and 95%, respectively (prevalence, 10.8%).2 Thus, the Vysis UroVysion test appears useful for diagnosis of bladder cancer in patients with hematuria.
Researchers have found that increased chromosomal instability and aneuploidy, such as that detected by the Vysis UroVysion test, are characteristic of bladder tumor progression. Due to its high specificity (~96%) and increased sensitivity (Figure 1),3 the Vysis UroVysion test is useful for early detection of bladder cancer recurrence when used in conjunction with cystoscopy. When the Vysis UroVysion test is positive and cystoscopy is negative, cancer recurs on average 4 months earlier than when both tests are negative; thus, a positive Vysis UroVysion test may indicate a need for increased surveillance in these cases.
Figure 1. Sensitivity of the Vysis UroVysion test as compared to that of urine cytology. Figure 1A shows sensitivity for tumor stages PTa, PTis, and PT1-PT4; Figure 1B shows sensitivity for tumor grades 1, 2, and 3; and Figure 1C shows overall sensitivity.3
1. Leading sites of new cancer cases and deaths. American Cancer Society Web site. Available at: http://www.cancer.org/downloads/stt/Leading_Sites_of_New_Cancer_Cases_and_Deaths_2005_Estimates.pdf. Accessed September 15, 2005.
2. UroVysionTM Bladder Cancer Kit – P030052. Food and Drug Administration Web Site. Available at: http://www.fda.gov/cdrh/pdf3/p030052b.pdf. Accessed September 15, 2005.
3. 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;164:1768-1775.
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