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Test ID FUROC UroVysion for Detection of Bladder Cancer, Urine

Useful For

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

 

Assessing patients with hematuria for urothelial carcinoma.

Method Name

Fluorescence In Situ Hybridization (FISH) Using DNA Probes

Reporting Name

UroVysion (R) for Bladder Cancer

Specimen Type

Varies

Specimen Type: Urine (voided urine, catheterized urine, bladder washings, stoma collections, ureteral brushings or washings, and renal pelvic brushings or washings)

Container/Tube:

Preferred: FISH for Urothelial Carcinoma in Urocyte Urine Collection Kit (T509)

Acceptable: 70% ethanol, PreservCyt, CytoLyt

Specimen Volume: 30 mL

Collection Instructions:

1. Specimen source is required on request form.

2. Follow instructions included with Urocyte Urine Collection Kit.

3. If kit is not used, submit a random urine specimen with an equal volume of 70% ethanol, PreservCyt, or CytoLyt.

Additional Information: Provide fixative, source, reason for referral (Evaluate for urothelial carcinoma or Hematuria. Evaluate for urothelial carcinoma.) and status of diagnosis (known previous diagnosis or suspected/unknown).

Forms: If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

Pathology Test Request Form (T246) (http://www.mayomedicallaboratories.com/it-mmfiles/pathology-request-form.pdf)

Oncology Test Request Form (T729) (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

Specimen Minimum Volume

30 mL is recommended, however, will not reject if <30 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Refrigerated (preferred)
  Ambient 

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 tumors 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 than urine cytology but similar specificity 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.

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).

 

This assay is intended for detecting tumor and does not provide information on tumor stage.

 

Biopsy may help clarify the diagnosis and tumor stage.

Day(s) Performed

Monday through Friday; 6 a.m.-8 p.m., Saturday 10 a.m.-6:30 p.m. and Sunday; 1 p.m.-9:30 p.m.

Report Available

4 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

88120

NY State Approved

Yes