Solid Tumors

The Bladder Cancer FISH test designed to detect aneuploidy for chromosomes 3, 7 and 17 and the 9p21 locus in urine specimens. This test is an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

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; however, these modalities have limited sensitivity. The Bladder Cancer FISH test 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). This test is useful for suspected bladder cancer patients with gross or microscopic hematuria, and may be used as an aid both in the initial diagnosis and the continued monitoring of previously-diagnosed patients.

methodology/product platform
Fluorescence in situ hybridization (FISH)

specimen type and requirements
Voided Urine: 33-60 mL voided urine mixed 2:1 with supplied PreservCyt within 30 minutes of collection for total volume ≥50 mL.
Refrigerate specimen. Do not freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

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

cpt code(s)
88121x1 automated. Codes may differ if manual analysis is performed.

medicare moldx cpt code
Not applicable

regulatory classification
New York-approved

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