Test ID: FMEL
Melanoma, FISH, Tissue
NY State Approved 
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
This test is intended to be used in conjunction with clinical and pathologic information to aid the pathologist in the differentiation of benign from malignant melanocytic lesions.
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
This test does not include a pathology consult. If a pathology consult is requested, 5439 Surgical Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.
Method Name A short description of the method used to perform the test
Fluorescence In Situ Hybridization (FISH)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Melanocytes
Melanocytic tumors
Nevus
RREB1
Skin cancer
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.
Provide a pathology report with each tissue specimen. The laboratory will not reject a specimen that arrives without this information but will hold the specimen until a pathology report is received.
Specimen Type: Tissue
Preferred: Formalin-fixed, paraffin-embedded tumor tissue block
Acceptable: 7 consecutive unstained 5-micron thick sections placed on positively charged slides
Collection Instructions: Include 1 hematoxylin and eosin-stained slide.
Forms: New York Clients-Informed consent is required. Please document on the request form or electronic order that a copy is on file. An Informed Consent for Genetic Testing (Supply T576) is available in Special Instructions
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Tissue | Ambient (preferred) | |
| Refrigerated | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Melanocytic tumors arising in the skin can present a significant diagnostic challenge. While many lesions can be easily classified as benign nevi or malignant melanoma based on histologic features alone, there is a significant subset of lesions that cannot be clearly defined as either benign or malignant. Because the course of treatment for malignant melanoma relative to benign lesions varies significantly from the time of diagnosis, accuracy and expediency of the diagnosis are of paramount importance. A (FISH) based test panel has been developed that can be used as a diagnostic aid in the differentiation of malignant from benign melanocytic lesions.
This test is intended to be used in conjunction with clinical and pathologic information to aid the pathologist in the differentiation of benign from malignant melanocytic lesions.
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.
Interpretation Provides information to assist in interpretation of the test results
The panel test is considered abnormal if certain parameters are met that have been shown to be observed in malignant melanocytic lesions and within normal limits if these parameters are not met. An abnormal result is not diagnostic of malignancy, nor does a normal result exclude malignancy. The results are intended to be interpreted in the context of the pathologic and clinical findings.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not approved by the FDA and it is best used as an adjunct to existing clinical and pathologic information.
Fixatives other than formalin (eg, Prefer, Bouin's) may not be successful for FISH assays. Although FISH testing will not be rejected due to non-formalin fixation, results may be compromised.
Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin-and-eosin slide may find it necessary to cancel testing
Supportive Data
FISH analysis was performed on paraffin-embedded tissue samples from 26 histologically nonmalignant nevi (normal) and 29 samples from patients suspected or diagnosed with melanoma based on histologic review.
No abnormalities were identified in the 26 nonmalignant lesions. Of the 29 suspected or diagnosed with melanoma cases, 26 were abnormal for at least 1 of the probes tested and at least 50% of the nuclei exhibited the abnormality. Three cases were considered equivocal since the abnormality was identified in less than 50% of nuclei.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Gerami P, Zembowicz A: Update on fluorescence in situ hybridization in melanoma: state of the art. Arch Pathol Lab Med 2011;135:830-837
2. Gerami P, Mafee M, Lurtsbarapa T, et al: Sensitivity of fluorescence in situ hybridization for melanoma diagnosis using RREB1, MYB, Cep6, and 11q13 probes in melanoma subtypes. Arch Dermatol 2010;146:273-278
3. Morey AL, Murali R, McCarthy SW, et al: Diagnosis of cutaneous melanocytic tumours by four-colour fluorescence in situ hybridisation. Pathology 2009;41(4):383-387
4. Gammon B, Beilfuss B, Guitart J, et al: Enhanced detection of spitzoid melanomas using fluorescence in situ hybridization with 9p21 as an adjunctive probe. Am J Surg Pathol 2012; 36(1):81-88
5. Gerami P, Jewell S, Pouryazdanparast P, et al: Copy number gains in 11q13 and 8q34 are highly linked to prognosis in cutaneous malignant melanoma. J Mol Diagn 2011;13(3):352-358
6. Pouryazdanparast P, Cowen D, Beilfuss B, et al: Distinctive clinical and histologic features in cutaneous melanoma with copy number gains in 8q24. Am J Surg Pathol 2012;36(2):253-264
Method Description Describes how the test is performed and provides a method-specific reference
This test uses 3 commercially available probes sets: a) RREB1/D6Z1/MYB/CCND1, b) CDKN2A/D9Z1, and c) D8Z2/MYC. Formalin-fixed, paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin stained slide are performed by a pathologist. Using the hematoxylin-and-eosin slide as a reference, target areas are etched with a diamond-tipped etcher on the back of the unstained slide to be assayed. For each probe set, tissue sections are hybridized and 2 technologists analyze 25 interphase nuclei each (150 total) with the results expressed as a percent of abnormal nuclei.(Unpublished Mayo method)
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; 6 a.m.-9 p.m., Saturday, Sunday; 6 a.m.-4 p.m.
Test reported Monday through Friday: 8 a.m.-5 p.m.
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.
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.
88271 x 8-Molecular cytogenetics (eg, FISH), each probe
88275-Interphase in situ hybridization (100-300 cells)
88291-Cytogenetics and molecular cytogenetics, interpretation and report
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 |
|---|---|---|
| 51328 | Specimen | In Process |
| 51329 | Specimen ID | In Process |
| 51330 | Source | In Process |
| 51331 | Order Date | N/A |
| 51332 | Reason For Referral | In Process |
| 51333 | Method | In Process |
| 51334 | Results | In Process |
| 51335 | Interpretation | In Process |
| 51336 | Amendment | In Process |
| 51337 | Consultant | In Process |
| 51338 | Released Date | N/A |
External
link
PDF
document
Excel
document
Word
document