UroVysion®: FISH

Methodology: 
Fluorescence in-situ hybridization (FISH)
Performed: 
Weekly
Reported: 
Within 7 days
Use: 
The UroVysion® Bladder Cancer Kit is an FDA-approved test that is designed to detect aneuploidy for chromosomes 3, 7 and 17, as well as the loss of the 9p21 locus via fluorescence in-situ hybridization (FISH), in urine specimens. Results from the UroVysion® Kit are intended:
  • As an aid for the initial diagnosis of bladder carcinoma in patients with hematuria (in conjunction with current standard diagnostic procedures such as urinary cytology); and
  • As subsequent monitoring for tumor recurrence in patients who have been previously diagnosed with bladder cancer.
Result: 
Interpretive report
Specimen Requirements: 

At least 35 mL of voided urine specimens or bladder wash

Specimen containers with preservative are available upon request. Alternatively, specimen can be preserved by mixing 2:1 with PreservCyt®. If urine is not shipped immediately after collection, refrigerate immediately and ship via overnight courier within 24 hours. Ship on ice packs. Specimens need to be stored and shipped at 2° - 8° C. In order to obtain the greatest yield of diagnostic material, a second-morning, clean-catch, voided urine specimen should be collected.
 
Unacceptable Conditions:
  • Frozen specimens
  • Urine volume less than 35 mL
  • Specimens not fixed with a UF PathLabs-provided Stabilur® tablet or in Saccomanno or PreservCyt® fixative
  • Specimens stored or shipped at temperatures at or above 25° C (room temperature)
  • Specimens more than 72 hours old
Stability (collection to initiation of testing):
  • Ambient: 12 hours
  • Refrigerated: Specimens greater than 24 hours old; specimens greater than 72 hours old (with a Stabilur® tablet)
Reference Values: 
  • Negative (interpretative report provided)
  • Normal signal pattern (2 signals per probe)
CPT Code (s): 
  • 88120 (manual)
  • 88121 (computer-assisted)
Notes: 

UFHPL Test #: 90055

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