UroVysion for Detection of Bladder Cancer, Urine
Use
The UroVysion assay is useful for monitoring for tumor recurrence in patients with a history of urothelial carcinoma involving the bladder or upper urinary tract. It is also used for assessing patients with hematuria for urothelial carcinoma. The test detects chromosomal abnormalities in urinary cells, specifically targeting the centromeres of chromosomes 3, 7, 17, and the 9p21 band, which is associated with the P16 tumor suppressor gene, helping to identify recurrent urothelial carcinoma with higher sensitivity than urine cytology.
Special Instructions
It is important to follow the instructions included with the Urocyte Urine Collection Kit for accurate specimen collection and avoid rejection of specimens, especially if unfixed for more than 48 hours after collection. Additionally, special forms may be needed for pathology and oncology test requests if not ordering electronically.
Limitations
This assay does not provide information on tumor stage and is not suitable as a standalone test for definitive diagnosis. Significant cell populations with chromosomal gains or homozygous 9p21 deletion most commonly indicate bladder cancer but may also suggest other genitourinary malignancies. Improper specimen handling, such as using unfixed specimens beyond 48 hours after collection, can lead to test rejection.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 82251-0
- 50397-9
- 82251-0
- 69047-9
- 42349-1
- 31208-2
- 18771-6
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Specimen
Urine
Volume
30 mL
Minimum Volume
Not provided
Container
FISH for Urothelial Carcinoma in Urocyte Urine Collection Kit
Collection Instructions
Follow instructions included with Urocyte Urine Collection Kit. If the kit is not used, submit a random urine specimen with an equal volume of 70% ethanol, PreservCyt, or CytoLyt.
Causes for Rejection
Unfixed specimens 48 hours after collection
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | Refrigerated (preferred) |