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Test ID FUROC UroVysion for Detection of Bladder Cancer, Urine


Necessary Information


1. Specimen source is required on request form (ie, voided, catheterized, bladder washing).

2. Provide fixative, source, reason for referral (evaluate for urothelial carcinoma or hematuria) and status of diagnosis (known previous diagnosis or suspected/unknown).



Specimen Required


Specimen Type: Urine

Sources: Voided urine, catheterized urine, bladder washings, stoma collections, ureteral brushings or washings, renal pelvic brushings or washings

Supplies: FISH for Urothelial Carcinoma Urine Collection Kit (T509)

Container/Tube:

Preferred: FISH for Urothelial Carcinoma in Urocyte Urine Collection Kit

Acceptable: 70% ethanol, PreservCyt, CytoLyt, ThinPrep UroCyte (UroCyte PreservCyt Solution)

Specimen Volume: 30 mL

Collection Instructions:

1. Follow instructions included with Urocyte Urine Collection Kit.

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


Forms

1. Pathology/Cytology Information (T707)

2. If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Secondary ID

35328

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

Special Instructions

Method Name

Fluorescence In Situ Hybridization (FISH) using DNA Probes

Reporting Name

UroVysion (R) for Bladder Cancer

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

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 fluorescence in situ hybridization (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 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.

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 tumors and does not provide information on tumor stage.

 

Biopsy may help clarify the diagnosis and tumor stage.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic 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. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88120

NY State Approved

Yes