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.,
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.,