Advances in Technology for Melanoma Diagnosis and Prognosis: An Expert Consensus Panel

September 2024 | Volume 23 | Issue 9 | 774 | Copyright © September 2024


Published online August 30, 2024

doi:10.36849/JDD.8365R1

Joshua Burshtein MDa, Danny Zakria MD MBAa, Brian Berman MD PhDb,g, Seemal R. Desai MDc, Aaron S Farberg MDd, Gary Goldenberg MDa, Brad Glick DO MPHe,f, Mark Nestor MD PhDb,g, Keyvan Nouri MD MBAb, Theodore Rosen MDh, Mark Lebwohl MDa, Darrell Rigel MD MSi, Milaan Shah MDa

aDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NYbDepartment of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FLcDepartment of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX, & Innovative Dermatology, Plano, TXdBare Dermatology, University of North Texas Health Science Center, Baylor Scott & White Health, Dallas, TXeGlick Skin Institute, Margate, FLfLarkin Community Hospital Palm Springs Campus Dermatology Resident Program, Hialeah, FLgCenter for Clinical and Cosmetic Research in Aventura, FLhDepartment of Dermatology, Baylor College of Medicine, Houston, TXiDepartment of Dermatology, NYU Grossman School of Medicine, New York, NY

Abstract
Background: Cutaneous melanoma (CM) is associated with a higher mortality rate than most other skin cancers. The purpose of this expert consensus panel was to review the published literature on new technological advancements for the diagnosis and prognosis for CM and provide updated guidance on their usage. Methods: A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the topics of non-invasive diagnostic and prognostic testing for CM, including gene expression profiling (GEP) and electrical impedance spectroscopy (EIS). A panel of 10 dermatologists with significant expertise in the treatment of CM gathered to review the articles and create consensus statements. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using widely recognized Strength of Recommendation Taxonomy criteria. Results: The literature search produced 200 articles that met the criteria. A screening of the studies resulted in 19 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 7 consensus statements and recommendations, 5 of which were given a strength of "A", 1 of which was given a strength of "B," and 1 of which was given a strength of "C". Conclusion: The 2-GEP test and EIS can aid in the precise diagnosis of clinically indeterminate lesions and the 23-GEP test can be used when histopathology is equivocal. The 31-GEP test can enhance prognostic assessment beyond AJCC8 staging and improve clinical decision-making. J Drugs Dermatol. 2024;23(9):774-781. doi:10.36849/JDD.8365R1

INTRODUCTION

Cutaneous melanoma (CM) is one of the most common malignancies in the United States and its incidence is growing.1 CM has a higher mortality rate than most skin cancers and early detection is critical, as prognosis is directly related to depth of invasion.2,3 The current standard of care for evaluating pigmented lesions is visual assessment, followed by biopsy for histopathological analysis if concerning features are present. Further, traditional CM prognostication is based on the eighth edition of the American Joint Committee on Cancer (AJCC8), which includes specific clinicopathologic features. To enhance patient care and improve outcomes, new technologies have been developed to aid clinicians in accurately diagnosing CM and determining prognosis.

The current standard for diagnosing melanoma via visual assessment has low sensitivity (84%) and specificity (<30%) for early-stage tumors, and 94% of lesions biopsied are negative for melanoma.4-7 In the clinical setting, dermoscopy is commonly used to improve diagnostic accuracy.8 However, there is a need for additional non-invasive testing that can reliably improve diagnostic sensitivity and specificity for melanoma. The 2-gene expression profile (GEP) test (DermTech, La Jolla, CA) is a gene expression assay using an adhesive patch-based sample collection platform for epidermal RNA. This test has demonstrated clinical utility and >99% negative predictive value (NPV) for CM.9-12 Another genetic-based test is the 23-GEP (MyPath Melanoma, Castle Biosciences, Inc.,
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