Bladder Cancer by FISH

Also known as: BC REQUEST

Clinical Use

Use

This test aids in the diagnosis of urothelial carcinoma and monitoring for tumor recurrence. It utilizes the UroVysion Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, and 17, and/or the loss of the 9p21 locus using fluorescence in situ hybridization (FISH). It is designed to detect genetic abnormalities commonly associated with urothelial cancers, providing critical information for both diagnosis and ongoing management of bladder cancer patients.

Special Instructions

Not provided.

Limitations

Negative results indicate a lack of chromosomal abnormalities indicative of urothelial carcinoma. However, negative results do not rule out cancer, particularly in the presence of clinical symptoms suggesting urothelial carcinoma. Further clinical evaluation may be needed in such cases. Positive results suggest the presence of urothelial carcinoma or other urologic malignancies, but confirmatory diagnostics and clinical correlation are necessary to determine the exact source of the cancerous cells. Some urothelial cancers might not be detected if they involve genetic changes outside the scope of this test.

Test Details

FDA Approved

New York Approved

Methodology

Chromosomal / Cytogenetics (FISH)

Biomarkers

4 targets

Unknown CNVUnknown CNVUnknown CNVUnknown CNV

LOINC Codes

Order Codes

66746-9 - Specimen type

Result Codes

66746-9 - Specimen type
8100-0 - Specimen preparation
22636-5 - Path report.relevant Hx Spec
22634-0 - Path report.gross Spec

Result Turnaround Time

4-14 days

Specimen

Urine

Volume

85 mL

Minimum Volume

35 mL

Container

PreservCyt collection vial

Collection Instructions

Collect a second-morning, clean-catch voided urine specimen using the UroCyte Urine Collection Kit.

Storage Instructions

Store transported specimens at ambient or refrigerated temperatures.

Causes for Rejection

Unfixed specimens not in PreservCyt fixative and frozen specimens are unacceptable. Specimens submitted in expired collection vials are also not accepted.