15335 Real-world utility of a noninvasive gene expression test to rule out primary cutaneous melanoma: A large US registry study

Abstract

The Pigmented Lesion Assay (PLA) analyzes gene expression to objectively rule out melanoma. The test uses a noninvasive adhesive patch-based sample collection platform that enables guidance on biopsy decisions and elevates pigmented lesion management beyond what can be visually ascertained. The test’s negative predictive value of 99%, and rapid, painless application make it an attractive pre-biopsy solution. It reduces biopsies by 90% while improving care and reducing cost. This registry study (53 US dermatology offices, 90 providers, median patient age 48 years, 60.80% female patients) assesses real-world utility to determine if the PLA changes clinical practice. The PLA assessed 3418 concerning pigmented skin lesions. Three hundred twenty-four lesions (9.48%) were PLA(+) and 3094 (90.52%) were negative. A PLA test result is positive if LINC, PRAME, or both target genes are detected. These molecular pathology findings are known to correspond with histopathology findings of in situ or invasive primary melanoma in 7%, 50%, and 93%, respectively. The 9.48% PLA(+) cases consisted of 5.15% LINC-only, 1.93% PRAME-only, and 2.40% LINC and PRAME double positive cases. Notably, PLA(+) lesions were almost universally surgically biopsied (97.53%), while PLA(−) cases were nearly always monitored and not biopsied (99.94%). These studies demonstrate that the PLA has true clinical value in community-based practices where providers make important decisions based on the test’s results. Pigmented lesions with PLA(+) test results are subjected to surgical biopsies, whereas PLA(−) lesions are followed clinically and not biopsied.