TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: MELF    
Melanoma, FISH, Tissue

Useful For Suggests clinical disorders or settings where the test may be helpful

An aid in the differentiation of benign from malignant melanocytic lesions when used in conjunction with clinical and pathologic information

Testing Algorithm Delineates situations 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 consultation is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.

 

This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results.

 

Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 US Food and Drug Administration and it is best used as an adjunct to existing clinical and pathologic information.

                          

Fixatives other than formalin (eg, Prefer, Bouin) 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-stained slide may find it necessary to cancel testing.

Supportive Data

FISH analysis was performed on 55 formalin-fixed, paraffin-embedded tissue samples, including 29 samples from patients suspected or diagnosed with melanoma and 26 histologically nonmalignant nevi (normal). The normal controls were used to generate a normal cutoff for this assay. Of the 29 suspected or diagnosed cases with melanoma, 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 <50% of nuclei.

Clinical Reference Recommendations for 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