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25208 UroVysion for Bladder Cancer Detection (FUROC)

UroVysion for Bladder Cancer Detection (FUROC)
Test Code: UROVYSO
Synonyms/Keywords
​Bladder Cancer; FISH for Bladder Cancer; FISH for Upper Urinary Tract Cancer; FISH Urothelial Cancer; UroVysion; FURO; Cytology FISH; UroVysion for Detection of Bladder Cancer, Urine; UroVysion for Bladder Cancer Detection (FUROC); U UROVYSO
Useful For
Monitoring for tumor recurrence in patients with a history of urothelial carcinoma involving the bladder or upper urinary tract and for assessing patients with hematuria for urothelial carcinoma
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Urine​ ​Urocyte Urine Collection Kit ​ ​30 mL 30 mL; but less than 30 mL will not be rejected​ ​
Collection Processing Instructions
​Please call Marshfield Labs' Customer Service to obtain kits. Follow instructions included with the Urocyte Urine Collection Kit. If kit is not used, submit a random urine specimen with an equal volume of 70% ethanol, PreservCyt, or CytoLyt.
Specimen Stability Information
Specimen Type Temperature
​Urine ​ Refrigerated (preferred)​
​Ambient
Interference

​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.​​

Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available
 Methodology/Instrumentation
Mayo Clinic Laboratories​ Monday through Friday
 7-10 days
Fluorescence In Situ Hybridization (FISH) Using DNA Probes​
Reference Lab
Mayo Clinic Laboratories
Test 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.

Reference Range Information
Interpretive Report
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

Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
88120​ ​ ​ ​ ​
Synonyms/Keywords
​Bladder Cancer; FISH for Bladder Cancer; FISH for Upper Urinary Tract Cancer; FISH Urothelial Cancer; UroVysion; FURO; Cytology FISH; UroVysion for Detection of Bladder Cancer, Urine; UroVysion for Bladder Cancer Detection (FUROC); U UROVYSO
Ordering Applications
Ordering Application Description
​COM UroVysion for Bladder Cancer Detection (FUROC)
​Cerner UroVysion for Bladder Cancer Detection (FUROC)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Urine​ ​Urocyte Urine Collection Kit ​ ​30 mL 30 mL; but less than 30 mL will not be rejected​ ​
Collection Processing
​Please call Marshfield Labs' Customer Service to obtain kits. Follow instructions included with the Urocyte Urine Collection Kit. If kit is not used, submit a random urine specimen with an equal volume of 70% ethanol, PreservCyt, or CytoLyt.
Specimen Stability Information
Specimen Type Temperature
​Urine ​ Refrigerated (preferred)​
​Ambient
Interference

​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.​​

Useful For
Monitoring for tumor recurrence in patients with a history of urothelial carcinoma involving the bladder or upper urinary tract and for assessing patients with hematuria for urothelial carcinoma
Reference Range Information
Interpretive Report
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

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available
 Methodology/Instrumentation
Mayo Clinic Laboratories​ Monday through Friday
 7-10 days
Fluorescence In Situ Hybridization (FISH) Using DNA Probes​
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
88120​ ​ ​ ​ ​
For most current information refer to the Marshfield Laboratory online reference manual.