Solid Tumors

The UroVysion Bladder Cancer Kit is FDA-approved and designed to detect aneuploidy for chromosomes 3, 7 and 17 and the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from patients with hematuria who are suspected of having bladder cancer.

UroVysion® is a registered trademark of Abbott Laboratories.

disease state indication(s)
Bladder Cancer

clinical use
Cystoscopy and morphologic cytology review are the current standard of care for the diagnosis and surveillance of bladder cancer [1]; however, these modalities have limited sensitivity. The UroVysion Bladder Cancer Kit is comprised of four FISH probes which evaluate for aneuploidies commonly associated with urothelial carcinoma: copy number gain of chromosomes 3, 7 and 17, and copy number loss of cytoband 9p21 (which includes the p16/CDKN2A tumor suppressor gene locus). The UroVysion Kit is FDA-approved for urine specimens from suspected bladder cancer patients with gross or microscopic hematuria, and is intended for use as an aid both in the initial diagnosis and the continued monitoring of previously-diagnosed patients.
The sensitivity of UroVysion was shown to be higher than that of cytology alone across all stages and grades [2]. However, negative results in the presence of clinical symptoms/signs may suggest the possibility of a false negative, and additional studies should be pursued as clinically indicated; definitively positive cystoscopy/cytology findings take priority over negative FISH. Positive UroVysion results in the absence of demonstrable bladder cancer may indicate another primary tumor site (such as ureter, urethra, kidney, or prostate), and further examination may be warranted. The performance of the UroVysion Bladder Cancer Kit depends on the number of tumor cells present on the slide analyzed; solitary stage Ta tumors <5mm in size are not detectable. [3]

References:
1. Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Bladder Cancer, Version 2.2018, page BL-1.
2. Sarosdy MF, et al. J Urol. 2006 Jul;176(1):44-7.
3. UroVysion Bladder Cancer Kit Package Insert 30-608385/R7

methodology/product platform
Fluorescence in situ hybridization (FISH)

specimen type and requirements
Only Voided Urine is accepted. If Bladder Wash is sent, Genoptix will run FISH probes as a LDT. Pour 60 mL(cc) urine into blue-capped container with PreservCyt® Solution.
A minimum of ≥ 33 mL(cc) voided urine is required. If collecting less than 60 mL(cc) of urine, prior to pouring urine adjust the volume of PreservCyt® to maintain a 2:1 ratio (v:v) of urine to PreservCyt® Solution. Recommended preservatives are Carbowax™ (2% polyethylene glycol in 50% ethanol) or PreservCyt®.

It is recommended to place urine in preservative immediately after collection. Keep the specimen refrigerated prior to shipping. Recommended to ship specimen with ice packs to Genoptix within 24 hours of collection. Specimen should not exceed 25°C.
DO NOT FREEZE.

turnaround time
Tech-only (TC): 3 days
Global (TC & PC): 5 days

cpt code(s)
88120 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
FDA approved/cleared

ordering option
Global (TC & PC) or Tech-only (TC)