Clinical and economic implications of a noninvasive molecular pathology assay for early detection of melanoma

Background: More than 90% of ∼2.5 million surgical biopsies performed to rule out melanoma in the U.S. alone are benign and classified as neither invasive melanomas nor melanomas in situ by histopathology. A recently described adhesive patch skin biopsy based noninvasive gene expression test (pigmented lesion assay; PLA) demonstrated utility and differentiated benign from malignant pigmented skin lesions with a test performance that exceeded visual inspection (VI) and a sensitivity that matching the criterion standard of dermatopathology.