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FISH Bladder Cancer (UroVysion)

T151

UroVysion® FISH

The assay is an FDA-approved diagnostic assay for the detection of bladder cancer, designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens. May also be used in subsequent monitoring for tumor recurrence in previously diagnosed patients. This assay does not detect other chromosomal or genetic alterations. Results are intended for use as a noninvasive method of monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The clinical interpretation of test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results.


Methodology: Fluorescence in situ Hybridization (FISH)
Performed: Varies
Reported: 3-4 days
Specimen Required: Collect: Random Urine -  33 ml urine

Specimen Preparation: Perform urine collection  at the physician's office or Patient Service Center (PSC) in a sterile urine specimen container. Mix voided urine with CytoLyt  a 1:1 solution (33 ml urine and 33 ml Cyto-Solution). See attached file.
OR  mix urine with CytoLyt  2:1 (33 ml urine and 15 ml Cyto-Solution).
It is recommended that specimens be processed within 72 hours of collection. 
Samples received without preservative will be assayed; any study under these conditions yielding insufficient cells or an abnormal result should have a follow-up study with urine in a preservative. 

Storage/Transport Temperature:
Refrigerated.
DO NOT FREEZE 

Stability:
Refrigerated 72 hours

Comment:
Specimen collection date is required.

NOTE: * This test is not available for New York patients, please refer to test code B454 for specimen requirements.*


Performing Laboratory 
Lincoln Diagnostics LLC, NJ
CPT Code(s): 88120

Clinical Use
  • Diagnose bladder cancer in patients with hematuria (in conjunction with standard diagnostic procedures)
  • Detect bladder cancer recurrence

Synonyms:
- Bladder Cancer
- Bladder Cancer FISH
- Bladder Tumor
- Bladder Tumor FISH
- FISH
- Urinary Tract Cancer
- Urothelial Carcinoma
- Urovysion

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