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Unit Code 81975:
UroVysion for Detection of Bladder Cancer

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Useful For

Monitoring for tumor recurrence in patients with a history of UC

involving the bladder or upper urinary tract and for assessing

patients with hematuria for urothelial carcinoma.

Clinical Information

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 r

ecurrent 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.

Reference Values

An interpretive report will be provided.

Interpretation

Positive:  any specimen satisfying 1 of the following criteria.

1. Four or more cells with gains of 2 or more chromosomes

2. 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)

3. 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.

 

Negative:

1. Fewer than 4 cells with gains of 2 or more chromosomes

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

3. Less than 20% of cells with homozygous 9p21 deletion

Cautions

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.

Special Instructions and Forms

• MayoConnect Additional Test Information 

Clinical Reference

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

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