Test Catalog

Test Id : FUROC

UroVysion for Detection of Bladder Cancer, Urine

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

 

Assessing patients with hematuria for urothelial carcinoma

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Fluorescence In Situ Hybridization (FISH) using DNA Probes

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

UroVysion (R) for Bladder Cancer

Aliases
Lists additional common names for a test, as an aid in searching

Bladder Cancer

FISH for Bladder Cancer

FISH for Upper Urinary Tract Cancer

FISH, Urothelial Cancer

UroVysion

FURO

Cytology FISH

Specimen Type
Describes the specimen type validated for testing

Varies

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
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

1. Pathology/Cytology Information (T707) in Special Instructions

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Unfixed specimens 48 hours after collection Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred)
Ambient

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

 

Assessing patients with hematuria for urothelial carcinoma

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 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 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.

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.

Interpretation
Provides information to assist in interpretation of the test results

Lower Tract Samples:

Abnormal: 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 20% or more of the cells analyzed

 

For cases that are abnormal, 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:

-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

 

Upper Tract Samples:

Abnormal: any upper tract specimen satisfying 1 of the following criteria:

-Four or more hypertetrasomy cells with at least 5 copies of 2 or more chromosomes

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

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

 

Negative:

-Fewer than 4 cells with hypertetrasomy with at least 5 copies of 2 or more chromosomes

-Fewer than 10% of cells with 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).

 

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

 

Biopsy may help clarify the diagnosis and tumor stage.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Halling KC, Kipp BR: Bladder cancer detection using FISH (UroVysion assay). Adv Anat Pathol. 2008:15(5):279-286. doi: 10.1097/PAP.0b013e3181832320.

2. Gayed BA, Seideman C, Lotan Y: Cost-effectiveness of fluorescence in situ hybridization in patients with atypical cytology for the detection of urothelial carcinoma. J Urol. 2013 Oct;190(4):1181-1186. doi: 10.1016/j.juro.2013.03.117

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Urinary cells are harvested, fixed, and placed on a slide. The UroVysion probe set, which contains fluorescently labeled DNA probes specific to the centromeres of chromosomes 3, 7, 17, and to the 9p21 locus is hybridized to the cells on the slide. The slide is washed and counterstained with 4',6-diamidino-2'-phenylindole dihydrochloride (DAPI) stain. Fluorescence microscopy with unique band filters is then used to scan the slide for atypical cells (eg, cells with nuclear enlargement or irregularity). These cells are assessed for gains of chromosomes (3, 7, 17) or homozygous 9p21 deletion. If the number of cells with chromosomal gains (polysomy or trisomy) or homozygous 9p21 deletion observed on scanning is sufficient to consider the test result positive, the percentage of transitional cells with polysomy, trisomy, or homozygous 9p21 deletion is determined.(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; 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;2:116-123. doi: 10.1016/S1525-1578(10)60625-3.)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Call Lab

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88120

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports