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Epic Code LAB2111388 UroVysion for Detection of Bladder Cancer, Urine

Additional Codes

Mayo Code:  FUROC

Epic Code: LAB2111388

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

Specimen Type

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


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.


Specimen Minimum Volume

See Specimen Required

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 Stability Information

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

Reject Due To

Unfixed specimens 48 hours after collection Reject

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.

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 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.

Method Name

Fluorescence In Situ Hybridization (FISH) using DNA Probes

Report Available

7 to 10 days

Reporting Name

UroVysion (R) for Bladder Cancer

Reference Values

An interpretive report will be provided.

Interpretation

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

Method Description

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.)

Day(s) Performed

Monday through Friday

Clinical Reference

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

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FUROC UroVysion (R) for Bladder Cancer 82251-0

 

Result ID Test Result Name Result LOINC Value
54674 Result Summary 50397-9
54675 Result 82251-0
54676 Interpretation 69047-9
54677 Reason for Referral 42349-1
54678 Specimen 31208-2
54679 Source 31208-2
54680 Released By 18771-6

Special Instructions