Real-World Utility Of A Noninvasive Gene Expression Test To Rule Out Primary Cutaneous Melanoma: A Large Us Registry Study

Introduction: The Pigmented Lesion Assay (PLA) is a non-invasive gene expression test that helps clinicians rule out melanoma via a genomics approach that elevates pigmented lesion management beyond what the eye can see. PLA improves care with a negative predictive value of >99% while reducing biopsies by 90% and while reducing cost. Methods: The registry study described here (53 US dermatology offices, 90 providers, median patient age 48 years, 60.80% female and 39.20% male patients) assesses real-world utility to determine if the PLA changes clinical practice. Results: Of 3,418 pigmented skin lesions clinically suspicious for melanoma and assessed by PLA, 324 lesions (9.48%) were PLA(+) and 3,094 (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, 97.53% of PLA(+) lesions were surgially biopsied, while 99.94% of PLA(-) cases were clinically monitored and not biopsied. Discussion: These findings demonstrate that community-based clinicians who employ the PLA to improve pigmented lesion management use the test's results to guide how they practice. Pigmented lesions with PLA(+) test results are subjected to surgical biopsies, whereas PLAN lesions are followed clinically and not biopsied.