Epic Code LAB1231756 Biliary Tract Malignancy by FISH

Important Note

Brushes should be sent in ThinPrep-Cytolyt solution. Brushes received in formalin or 95% ETOH cannot be processed.

Test Name Alias

Bile duct cancer | Bile duct malignancy | Bile duct FISH

Interface Order Alias

1231756

Clinical Information

Biliary Tract Malignancy testing by fluorescence in situ hybridization (FISH) is useful in assessing bile duct brushing or hepatobiliary brushing specimens for biliary tract malignancy. FISH can be used to detect cells with chromosomal changes (eg, aneuploidy) that are indicative of malignancy. Studies have indicated that the use of FISH to detect malignant cells in biliary brush specimens is useful as a screening tool, in addition to conventional cytology.

References

1. Barr Fritcher EG, Voss JS, Brankley SM, et al. An optimized set of fluorescence in situ hybridization probes for detection of pancreatobiliary tract cancer in cytology brush samples. Gastroenterology. 2015;149(7):1813-1824. doi:10.1053/j.gastro.2015.08.046

2. Barr Fritcher EG, Kipp BR, Voss JS, et al. ST27: The development of a tailored pancreatobiliary fluorescence in situ hybridization (FISH) assay to improve detection of malignancy in pancreatobiliary brushings. J Mol Diagn. 2013;15(6):909

3. Barr Fritcher EG, Kipp BR, Halling KC, et al. A multivariable model using advanced cytologic methods for the evaluation of indeterminate pancreatobiliary strictures. Gastroenterology. 2009;136(7):2180-2186. doi:10.1053/j.gastro.2009.02.040

Specimen Type

Bile duct brushing, bile duct aspirate, hepatobiliary brushing, or hepatobiliary aspirate

Collection Instructions

Specimen Collection: Bile duct brushing, bile duct aspirate, hepatobiliary brushing, or hepatobiliary aspirate (fine-needle aspiration is not acceptable)

Container(s): ThinPrep Cytolyt solution

Minimum Volume to Collect: Entire collection

Collection Instructions:

Brushes should be sent in ThinPrep Cytolyt solution
Brushes received in formalin or 95% ETOH cannot be processed
Fine-needle aspiration is not acceptable

Processing Instructions (Laboratory, Outpatient or Off-site collection)

Transport Temperature: Refrigerated (Preferred); Ambient (Room Temperature)

Rejection Criteria

Brushes received in formalin or 95% ETOH cannot be processed
Fine-needle aspiration is not acceptable

Specimen Stability

Refrigerated (preferred)

Cytolyt solution: store the containers at 15°-30°C (59° -86°F) without cells.

Cells in Cytolyt solution are preserved for 8 days at room temperature. The 8 days at room temperature time pertains to samples in minimum Cytolyt solution to sample ratio of 1 part Cytolyt solution to 3 parts sample.

For best results, transport specimen to laboratory immediately for processing.

If there is a delay, refrigerate solution until it is delivered to the laboratory.

When transporting solution vials containing cells to the laboratory, make sure the vial is tightly sealed. Align the mark on the cap with the mark on the vial to prevent leakage.

Test Frequency

Test run Mondays - Fridays, 1st shift. Turn-around time is 5-7 business days

Reference Range

An interpretative report will be provided.

Performing Department

Cytogenetics

Performing Department Laboratory Location

Corewell Health Advanced Technology Laboratory (ATL), Grand Rapids, MI

Methodology

Performed by fluorescence in-situ hybridization (FISH), fluorescently labeled DNA probes to 1q21/MCL1, 7p12/EGFR, 8q24/MYC, and 9p21/CDKN2A (Vysis®) are hybridized to uncultured biliary cells. This test was developed and its performance characteristics determined by Corewell Health Cytogenetics West. It has not been cleared or approved by the U.S. FDA. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes.

CPT

88377 HC M/PHMTRC ALYS ISH QUANT/SEMIQ MNL EACH MULTIPRB

CDM Code

3108837702

Epic Test ID

Currently Unavailable

LOINC

Unavailable

Mayo Access Code