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Background: Despite the clinical availability and widespread usage of diagnostic and prognostic gene expression profiles (GEP) for the management of melanoma, no recommendations for Appropriate Use Criteria (AUC) exist to guide their integration into clinical practice.Objective: To develop a set of consensus-based AUC recommendations for the use of GEP profiling technology in the diagnosis and management of melanoma in specifically-defined situations commonly encountered by the practicing dermatologist.Methods: A systematic Medline literature search was performed to identify all existing evidence pertinent to the clinical efficacy and utility of three melanoma GEP tests that met the inclusion criteria (validated in peer-reviewed literature, US governmentally approved, and currently widely used) for review. A modified Delphi technique was used to achieve consensus and standard SORT criteria were applied. An expert panel of nine dermatologists/dermatologic surgeons/dermatopathologists developed a set of 29 clinical scenarios for the appropriate use of GEP assays and reviewed the available literature to make evidence-based recommendations for each indication.Results: The 2-GEP assay for melanoma diagnosis received 1 B-strength and 6 C-strength recommendations. The 23-GEP diagnostic test received 1 A-strength, 3 B-strength, and 4 C-strength recommendations. The 31-GEP prognostic assay received 1 A-strength, 7 B-strength, and 6 C-strength recommendations.Conclusions: These AUC recommendations provide an evidence-based framework for the integration of melanoma GEP tests into clinical practice.

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To decrease morbidity and mortality from melanoma, it is imperative to identify patients who are at high risk for developing widespread disease. Gene expression profiling (GEP) technology may impact melanoma management as physicians are better equipped to measure prognosis. Many different GEP signatures have been investigated. We searched Pubmed, Cochrane CENTRAL, and Embase for studies on GEP in primary melanoma prognosis and assessed GEP signatures for prognostic and analytic validity and clinical impact. The relationship between GEP and survival was measured using hazard ratios (HR) and odds ratios (OR). We found twenty-nine articles comprising 9 gene signatures meeting inclusion criteria and conducted a meta-analysis on 6 studies on a 31-gene signature. High-risk GEP status was associated with poorer recurrence-free survival (HR=7.22; 95% CI, 4.75-10.98), distant metastasis-free survival (HR=6.62; 95% CI, 4.91-8.91), and overall survival (HR=7.06; 95% CI, 4.44-11.22); as well as sentinel lymph node biopsy positivity (OR=2.99; 95% CI, 2.15-4.15). With recent improvements in treating advanced melanoma, accurately assessing prognosis is important. This study has clinical implications for melanoma patients who may benefit from prognostic testing. These results may be useful to clinicians when ordering GEP testing and help them make better management decisions.

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