Pancreatobiliary FISH by UroVysion
- Tech Only CPT
- Tech Pro CPT 88121
- PowerPath Code UROFISH Bile
- Schedule Monday - Thursday
- Turn Around Time 4-7 days
- Disease State Pancreatic Cancer
- Methodology FISH
Organs
Specimen Requirements
1. Obtain specimen on brush by brushing lesion.
2. Cut off brush end and place in CytoLyt/Saline solution immediately.
Clinical Significance
The UroVysion™ Kit is designed to detect aneuploidy for chromosomes 3, 7 and 17 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 pancreatobiliary carcinoma in biliary brushing and fine needle aspiration biopsy samples.
Storage and Transportation
Store and transport refrigerated or room temperature
Cause for Rejection
Specimens received in inappropriate fixative; Specimen containers without two (2) patient identifiers.
Retention
1 week after final report is issued.
Comments
Though UroVysion FISH has a high PPV, a negative result does not completely rule out malignancy and cytologic correlation is recommended. A positive polysomy FISH result significantly increases the specificity for malignancy.
This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.