UroVysion FISH
8100600
 
Ordering Recommendation
May be useful in diagnosis of urothelial carcinoma and monitoring of tumor recurrence.
Mnemonic
UF
Methodology
Fluorescence in situ Hybridization/Computer Assisted Analysis/Microscopy
Performed
Weekly
Reported
4-12 days
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Indications: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as 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.  
Collect
A minimum of 35 mL of voided urine specimens.

Supplies:
ThinPrep UroCyte Urine Collection Kit (UroVysion FISH Collection Kit # 41440),or PreservCyt or Saccomanno fixative, and a Cytology test request form.
UroCyte Urine Collection Kits can be ordered through ARUP Client Services at (800) 522-2787 or (801) 583-2787 extension 2170.

Collection Procedure:
Collection Kit: For purposes of obtaining the greatest yield of diagnostic material, a second-morning, clean-catch voided urine specimen should be collected, if possible. Urine is collected in the blue capped specimen collection cup. If urine exceeds 60mL pour off the excess into a second specimen collection cup. Carefully pour the entire contents of the PreservCyt solution into the specimen collection cup(s) containing urine. Tightly secure the blue cap on the specimen collection cup. Keep turning until you hear the audible click. Alternatively, if you do not have a collection kit, urine can be collected and mixed two parts urine to one part PreservCyt or Saccomanno fixative.The specimen should be labeled with the patient's first and last name, date of birth, specimen source, medical record number (or other unique identifier), and collection date. Submit the specimen along with the completed Cytology request form to the Cytopathology Laboratory. Specimen needs to be stored and transported refrigerated. The specimen must be accompanied by a Cytology test request form with the requested test marked and pertinent clinical history recorded.  
Specimen Preparation
 
Storage/Transport Temperature
 
Unacceptable Conditions
Refrigerated specimens not fixed in Saccomanno or PreservCyt. Urine volume less than 35 mL.  
Remarks
 
Stability
Refrigerated: 72 hours (must be fixed with Saccomanno or PreservCyt fixative)  
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: 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 the Vysis UroVysion Kit was designed to detect genetic abnormality associated with most urothelial cancers, there will be some urothelial cancers for which genetic changes cannot be detected by the UroVysion Test.

Positive:
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 Vysis UroVysion Bladder Cancer Kit (UroVysion Kit) is approved for use by the U.S. Food and Drug Administration.
Note
CPT Code(s)
88121; If manual: 88120
Components
Cross References
  • Bladder Cancer FISH
  • Urinary Tract Cancer
  • Urothelial Carcinoma