Barrett's-Associated Neoplasia, Cytology and FISH
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Aid to identifying dysplasia and adenocarcinoma in patients with Barrett's esophagus
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
|Test ID||Reporting Name||Available Separately||Always Performed|
|8026||Barrett's Neoplasia, Cytology||No||Yes|
|88704||Barrett's Neoplasia, FISH||No||Yes|
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When this test is ordered, esophageal cytology and esophageal brushing FISH test will always be performed at an additional charge.
Light Microscopy/Fluorescence In Situ Hybridization (FISH)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Barrett's Neoplasia Cytology,FISH
Esophageal Cancer Brushing
Esophageal Cancer Brushing
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Test available ONLY to the Florida and Scottsdale/Phoenix accounts.
Container/Tube: ThinPrep vial containing 20 mL PreservCyt solution (Supply T536)
Specimen Volume: Esophageal brushing
Note: Source of specimen, physician's name and telephone number, and a copy of the cytology report are required.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Barrett's esophagus is a preneoplastic condition that results in the transformation of benign squamous epithelium of the esophagus into specialized glandular intestinal mucosa. Patients with Barrett's esophagus are at a significantly increased risk for developing esophageal adenocarcinoma and, therefore, require close monitoring. Guidelines recommend periodic endoscopic examination of the esophagus with 4-quadrant biopsies taken every 1 cm to 2 cm of affected esophagus. Currently, histology results are considered the gold standard for diagnosing esophageal dysplasia and adenocarcinoma. However, there are many limitations of biopsy including limited sampling of the affected area, lengthy procedure time for biopsy collection, poor interobserver reproducibility of pathologists to diagnose dysplasia or adenocarcinoma, and an inability of histologic findings to predict patient progression from Barrett's esophagus to esophageal adenocarcinoma.(1)
FISH, a technique that utilizes fluorescently labeled DNA probes to examine cells for chromosomal alterations, can be used to detect cells with chromosomal changes (eg, polysomy) that are indicative of neoplasia (dysplasia or adenocarcinoma). Studies indicate that a multicolor, multitarget FISH assay that utilizes probes to 8q24 (MYC), 9p21 (CDKN2A), 17q12 (ERBB2; alias HER-2), and 20q13.2 (ZNF217), is able to detect dysplasia and adenocarcinoma in endoscopic esophageal brushing specimens collected from patients with Barrett's esophagus.(1,2)
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided.
An interpretive report is provided based on the combination of routine cytology and FISH results.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Negative FISH results do not rule out the presence of dysplasia or adenocarcinoma.
While polysomic FISH results are suggestive of high-grade dysplasia or adenocarcinoma, biopsy confirmation should be obtained before therapeutic interventions are instituted. Patients with a positive FISH result but negative biopsy should be followed closely.
This test cannot distinguish high-grade dysplasia from adenocarcinoma; both have been shown to exhibit the same type of FISH abnormalities.
A study was performed at Mayo Clinic to determine the relative sensitivities and specificities of FISH, conventional cytology, and DNA ploidy analysis with digital image analysis (DIA).(3) This study utilized 119 specimens from 97 patients. Endoscopic histology results were used as the gold standard for determining sensitivity and specificity of the assay. The histologic classification and number of specimens analyzed were as follows: benign squamous epithelium, 24; intestinal metaplasia, 22; low-grade dysplasia (LGD), 25; high-grade dysplasia (HGD), 24; adenocarcinoma, 24. The sensitivity of cytology, DIA, and FISH for LGD was 4%, 8%, and 48% (P < or =0.05); for HGD was 29%, 42%, and 79% (P < or =0.05); and for adenocarcinoma was 42%, 47%, and 89% (P < or =0.05). The specificity of cytology, DIA, and FISH among patients with a corresponding benign squamous epithelium biopsy result of was 88%, 88%, and 96%, respectively, (P=0.51), and was 93%, 93%, and 76%, respectively, among patients with a corresponding biopsy of either benign squamous epithelium or intestinal metaplasia.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Brankley SM, Wang KK, Harwood AR, et al: The development of a fluorescence in situ hybridization assay for the detection of dysplasia and adenocarcinoma in Barrett's esophagus. J Mol Diagn 2006 May;8(2):260-267
2. Rygiel AM, Milano F, Ten Kate FJ, et al: Gains and amplifications of c-myc, EGFR, and 20q13 loci in the no dysplasia-dysplasia-adenocarcinoma sequence of Barrett's esophagus. Cancer Epidermiol Biomarkers Prev 2008;17:1380-1385
3. Barr Fritcher EG, Brankley SM, Kipp BR, et al: A comparison of conventional cytology, DNA ploidy analysis, and fluorescence in situ hybridization for the detection of dysplasia and adenocarcinoma in patients with Barrett's esophagus. Hum Pathol 2008;39:1128-1135
Method Description Describes how the test is performed and provides a method-specific reference
For cytology analysis, brushing specimens are processed and slides are prepared using the ThinPrep 2000 processor. Specimens are then stained using a Papanicolaou stain and analyzed microscopically by a cytotechnologist and pathologist.
For FISH analysis, slides prepared from esophageal brushing specimens are assessed by FISH for the presence of cells that have chromosomal abnormalities consistent with a diagnosis of malignancy (Barr Fritcher EG, Brankley SM, Kipp BR, et al: A comparison of conventional cytology, DNA ploidy analysis, and fluorescence in situ hybridization for the detection of dysplasia and adenocarcinoma in patients with Barrett's esophagus. Human Pathology 2008;39:1128-1135)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
88112-Cytology, bronchial brush
88368 x 4-Morphometric analysis, manual, FISH
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|20408||Ref Path/Phys Address||In Process|
|20416||SP Signing Pathologist:||N/A|
|20417||*Previous Report Follows*||N/A|