Interpretive Handbook

Test 81975 :
UroVysion for Detection of Bladder Cancer

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Cystoscopy and urine cytology have been the primary methods for detecting urothelial carcinoma (UC). Unfortunately urine cytology has relatively poor sensitivity for the detection of recurrent UC. This is problematic because patients who have undetected recurrent tumor(s) may have tumor progression that places them at increased risk of developing metastatic UC.


The UroVysion assay is a FISH assay for the detection of recurrent UC. The UroVysion probe set contains probes to the centromeres of chromosomes 3, 7, and 17, and a locus-specific probe to the 9p21 band (site of the P16 tumor suppressor gene). The UroVysion assay detects cells with chromosomal abnormalities that are consistent with a diagnosis of UC. Studies have shown that the assay has higher sensitivity but similar specificity than urine cytology for the detection of recurrent UC. The UroVysion assay also demonstrates higher specificity than the BTA-stat assay for recurrent UC.


See Fluorescence In Situ Hybridization for the Detection of Urothelial Carcinoma in Publications.

Useful For Suggests clinical disorders or settings where the test may be helpful

Monitoring for tumor recurrence in patients with a history of urothelial carcinoma involving the bladder or upper urinary tract and for assessing patients with hematuria for urothelial carcinoma

Interpretation Provides information to assist in interpretation of the test results

Positive: any specimen satisfying 1 of the following criteria.

-Four or more cells with gains of 2 or more chromosomes

-Ten or more cells with a gain of a single chromosome or 10 or more cells with tetrasomic signal patterns (ie, 4 copies for each of the 4 probes)

-Homozygous deletion of the 9p21 locus in > or =20% of the cells analyzed


For cases that are positive, the percentage of abnormal cells and type of chromosomal abnormality (ie, polysomy, trisomy, tetrasomy, or homozygous 9p21 deletion) are indicated in the test report.



-Fewer than 4 cells with gains of 2 or more chromosomes

-Fewer than 10 cells with gain of a single chromosome or tetrasomy

-Less than 20% of cells with homozygous 9p21 deletion

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Significant cell populations with chromosomal gains or homozygous 9p21 deletion indicate that the patient has a genitourinary malignancy, which is most frequently bladder cancer, or (much less likely) a metastatic involvement of the genitourinary tract. However, the patient may have another genitourinary malignancy (eg, renal pelvic or ureteral transitional cell carcinoma, prostatic carcinoma with urethral invasion, renal cell carcinoma, or metastatic cancer involving the genitourinary tract). The assay is intended for detecting tumor and does not provide information on tumor stage. Biopsy may help clarify the diagnosis and tumor stage.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Clinical References Provides recommendations for further in-depth reading of a clinical nature

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;164(5):1768-1775

2. Sokolova IA, Halling KC, Jenkins RB, et al: The development of a multi-target, multi-color fluorescence in situ hybridization assay for the detection of urothelial carcinoma in urine. J Mol Diagn 2000;2(3):116-123

3. 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;167(5):2001-2006

4. Halling KC: Vysis UroVysion for the detection of urothelial carcinoma. (erratum appears in Expert Rev Mol Diagn. 2004 Mar,4[2]:266). Expert Review of Molecular Diagnostics. 2003 Jul;3(4):507-19