UroVysion for Detection of Bladder Cancer
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Fluorescence In Situ Hybridization (FISH) Using DNA Probes
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
UroVysion(TM) for Bladder Cancer
FISH for Bladder Cancer
FISH for Upper Urinary Tract Cancer
FISH, Urothelial Cancer
FISH for Bladder Cancer
FISH for Upper Urinary Tract Cancer
FISH, Urothelial Cancer
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Specimen Type: Urine
Preferred: FISH for Urothelial Carcinoma in Urocyte Urine Collection Kit (Supply T509)
Acceptable: 70% ethanol, PreservCyt, CytoLyt
Specimen Volume: 30 mL is recommended, however, will not reject if <30 mL
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.
Additional Information: Provide reason for referral and status of diagnosis (known previous diagnosis or suspected/unknown).
Forms: If not ordering electronically, submit a Pathology/Cytology Request Form (Supply T246) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
30 mL is recommended, however, will not reject if <30 mL
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
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 tumor(s) 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 but similar specificity than urine cytology 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 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.
Positive: 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 > or =20% of the cells analyzed
For cases that are positive, the percentage of abnormal cells and type of chromosomal abnormality (ie, polysomy, trisomy, tetrasomy, or homozygous 9p21 deletion) are indicated in the test report.
-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
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). The 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 Provides recommendations for further in-depth reading of a clinical nature
1. 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(5):1768-1775
2. 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(3):116-123
3. Halling KC, King W, Sokolova IA, et al: A comparison of BTA stat, hemoglobin dipstick, telomerase, and Vysis UroVysion assays for the detection of urothelial carcinoma in urine. J Urol 2002;167(5):2001-2006
4. Halling KC: Vysis UroVysion for the detection of urothelial carcinoma. (erratum appears in Expert Rev Mol Diagn. 2004 Mar,4:266). Expert Review of Molecular Diagnostics. 2003 Jul;3(4):507-19
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 Vysis UroVysion probe set, which contains fluorescently labeled DNA probes specific to the centromeres of chromosomes 3, 7, and 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. 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; Halling KC, King W, Sokolova IA, et al: A comparison of BTA stat, hemoglobin dipstick, telomerase, and Vysis UroVysion assays for the detection of urothelial carcinoma in urine. J Urol 2002; 167:2001-2006)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 6 a.m.- 8 p.m., Saturday 10:00 a.m. â€“ 6:30 p.m. and Sunday; 1 p.m.- 9:30 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|16872||Reason For Referral||42349-1|