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Bladder Cancer, FISH

Bladder Cancer, FISH

Test Highlight

Bladder Cancer, FISH


Clinical Use

  • Diagnose bladder cancer in patients with hematuria (in conjunction with standard diagnostic procedures)

  • Detect bladder cancer recurrence

Clinical Background

It is estimated that in 2012 the number of new cases of bladder cancer in the U.S. will be 73,510.1 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 (Table),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.

Table. Sensitivity of Urine Cytology and the UroVysion FISH Assay3
Urine Cytology FISH












Overall sensitivity 58 81


In this fluorescence in-situ hybridization (FISH) method, a mixture of CEP 3, CEP 7, CEP 17, and LSI p16 probes, each labeled with a different fluorochrome, is used to enumerate chromosomes 3, 7, and 17 and detect the 9p21 locus deletion on chromosome 9.

Interpretive Information

A positive result is consistent with a diagnosis of bladder cancer or bladder cancer recurrence, either in the bladder or in another site within the urinary system. A negative result is suggestive of the absence of bladder cancer but does not rule it out.


  1. American Cancer Society. Cancer Facts and Figures 2012. Available at: http://www.cancer.org/Research/CancerFactsFigures/index. Accessed September 28, 2012.

  2. UroVysion® 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.

Content reviewed 05/2013

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