Ordering Recommendation

Detect aneuploidy for chromosomes 3, 7, and 17. Use in conjunction with current standard diagnostic procedures as an aid for diagnosis of pancreatic cancer.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Bile or pancreatic duct brushings, biliary stent, or fine needle aspirates of the pancreas in UroCyte Collection Kit (ARUP Supply #41440) available online through eSupply using ARUP Connect™ or contact Client Services at 800-522-2787. For specific instructions, refer to Specimen Collection & Handling.

Specimen Preparation

Place specimen in Cytolyt or PreservCyt fixative vial. If the specimen is a brushing, submit the brush in the fixative. Specimen should be placed in fixative vial immediately after collection.

Storage/Transport Temperature

Ambient or refrigerated.

Unacceptable Conditions

Frozen specimens.
Unfixed specimens not collected in Cytolyt or PreservCyt fixative.

Remarks

Specimen source is required.

Stability

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

Methodology

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 pancreatobiliary carcinoma identified.
Positive: Numeric chromosomal aberrations associated with pancreatobiliary carcinoma identified.

Interpretive Data

NEGATIVE results indicate a lack of evidence for the presence of numeric chromosomal abnormalities commonly associated with pancreatobiliary cancer within the cells collected in this specimen. Negative results in the presence of other symptoms/signs of pancreatobiliary carcinoma may suggest the possibility of a false negative test. In this circumstance, additional clinical studies to exclude pancreatobiliary carcinoma should be pursued, as clinically indicated.
Although this test was designed to detect genetic abnormality associated with most pancreatobiliary cancers, there will be some pancreatobiliary 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 pancreatobiliary carcinoma or other pancreatic malignancy from another site (bile or pancreatic duct brushings, biliary stent, orfi ne needle aspirates of the pancreas) within the cells collected in this specimen. Positive results in the absence of clinical documentation may require further clinical evaluation to exclude these as a source of the abnormal cells is justified.
UroVysion Bladder Cancer Kit probes were used 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 proceduresas an aid for initial diagnosis of pancreatobiliary carcinoma or related sources.

Compliance Category

Laboratory Developed Test (LDT)

Note

Results of this test must be interpreted in conjunction with clinical evidence and other laboratory testing and should not be used alone as a diagnosis of pancreatobiliary carcinoma.

A positive fluorescence in situ hybridization (FISH) result does not identify location or type of malignancy. FISH abnormalities may be associated with high-grade dysplasia or carcinoma in situ. Cytology and biopsy may help clarify such situations.

Hotline History

N/A

CPT Codes

88366 

Components

Component Test Code* Component Chart Name LOINC
2002452 Pancreatobiliary FISH Specimen Source 66746-9
2002458 Fixative 8100-0
2002459 Pancreatobiliary FISH Clinical History 22636-5
2002463 Pancreatobiliary FISH 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

  • Bile Duct FISH
  • Bile Duct Tumor
  • Biliary Tract Malignancy FISH
  • Cholangiocarcinoma FISH
  • Cytology
  • FISH
  • Pancreas FISH
  • UroVysion
Pancreatobiliary FISH