Ordering Recommendation

May aid in diagnosis of urothelial carcinoma and monitoring for tumor recurrence.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Second-morning, clean-catch voided urine specimen collected in PreservCyt collection vial included in UroCyte Urine Collection Kit (ARUP Supply #41440). Collection kit is available online through eSupply using ARUP Connector contact Client Services at 800-522-2787. For specific instructions refer to Specimen Collection & Handling.

Specimen Preparation

Specimens must be transported in PreservCyt fixative. Acceptable source is voided urine. (Min: 35 mL)

Storage/Transport Temperature

Ambient or refrigerated

Unacceptable Conditions

Unfixed specimens not in PreservCyt fixative. Frozen specimens. Specimens submitted in expired collection vials.

Remarks

Submit source information with the specimen.

Stability

Ambient: 1 week from collection; Refrigerated: 1 week from collection; Frozen: Unacceptable

Methodology

Qualitative Fluorescence in situ Hybridization (FISH)/Computer Assisted Analysis/Microscopy

Performed

Mon-Fri

Reported

4-14 days

Reference Interval

Negative: No evidence of numeric chromosomal aberrations associated with urothelial carcinoma identified.
Positive: Numeric chromosomal aberrations associated with urothelial carcinoma identified.

Interpretive Data

NEGATIVE results indicate a lack of evidence for the presence of numeric chromosomal abnormalities commonly associated with urothelial carcinoma within the cells collected in this specimen. Negative results in the presence of other symptoms/signs of urothelial carcinoma may suggest the possibility of a false negative test. In this circumstance, additional clinical studies to exclude urothelial carcinoma should be pursued, as clinically indicated. Although this test was designed to detect genetic abnormality associated with most urothelial cancers, there will be some urothelial cancers whose genetic changes cannot be detected by this test.

POSITIVE results indicate the presence of one or more numeric chromosomal abnormalities commonly associated with urothelial carcinoma within the cells collected in this specimen. Positive results in the absence of clinical documentation of urothelial carcinoma within the bladder suggest the possibility of urothelial carcinoma or other urologic malignancy from another site (including ureter, kidney, urethra, and prostate). In this circumstance, further clinical evaluation to exclude these as a source of the abnormal cells is justified.

The UroVysion Bladder Cancer Kit probes were used to detect aneuploidy for chromosomes 3, 7, 17, and/or loss of 9p21 locus via fluorescence in situ hybridization (FISH). Results from this test are intended for use in conjunction with, and not in lieu of, current standard diagnostic procedures, as an aid for initial diagnosis of urothelial carcinoma and for monitoring for tumor recurrence in conjunction with cystoscopy in patients with previously diagnosed bladder cancer.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

88121

Components

Component Test Code* Component Chart Name LOINC
3016657 Bladder Cancer FISH Specimen Source 66746-9
3016658 Fixative 8100-0
3016659 Clinical History 22636-5
3016660 Gross Description 22634-0
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Bladder Cancer
  • Bladder Cancer FISH
  • Bladder Tumor
  • Bladder Tumor FISH
  • Cytology
  • FISH
  • Urinary Tract Cancer
  • Urothelial Carcinoma
  • UroVysion
Bladder Cancer by FISH