Appropriate Use Criteria for the Integration of Diagnostic and Prognostic Gene Expression Profile Assays into the Management of Cutaneous Malignant Melanoma: An Expert Panel Consensus-Based Modified Delphi Process Assessment

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.