DermTech Pigmented Lesion Assay to Enrich Melanoma Positivity Nearly Five-Fold in Biopsied Lesions
January 14, 2021 at 09:30 pm
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DermTech, Inc. announced that SKIN has published the results of a registry study finding that the evaluation of genomic atypia using DermTech’s Pigmented Lesion Assay may be a superior approach to guide treatment decisions and manage pigmented lesions, when compared to visual assessment of pigmented lesions. Melanoma is a life-threatening skin cancer where early detection and intervention can significantly improve clinical outcomes and eliminate disease. An estimated 196,060 cases of melanoma were expected to be diagnosed in the United States in 2020 and expected to cause approximately 6,850 deaths, many of which could have been prevented through early detection. The study Genomic Atypia to Enrich Melanoma Positivity in Biopsied Lesions: Gene Expression and Pathology Findings – A Large U.S. Registry reports that lesions biopsied based on genomic atypia criteria identified by the PLA were associated with a nearly five-fold enrichment of melanoma in the patient specimens compared to those biopsied based solely on visual assessment criteria. This is the 20th peer-reviewed publication supporting use of the PLA to better guide treatment decisions. This large, year-long registry study conducted in the U.S. included 90 providers across 53 dermatology offices and assessed 3,418 pigmented lesions clinically suspicious for melanoma using the PLA. PLA-positive lesions were then biopsied using standard pathological methods. Pathology reports for 313 of 316 PLA-positive cases biopsied to rule out melanoma based on genomic atypia were available for subsequent analysis by the research team. The results of the study demonstrate that: Overall, 18.7% (59/316) of PLA positive lesions were histopathologically diagnosed as melanomas with 14.9% (47/316) diagnosed as melanomas in situ and 3.8% (12/316) as invasive melanomas. 47.5% of the histopathologically-confirmed melanomas demonstrated a double positive genomic signature (LINC and PRAME) while 23.7% were single-positive for LINC and 28.8% were single-positive for PRAME. Gene expression of both LINC and PRAME was present in increasing percentages of melanocytic lesions, corresponding with pathology reports showing increasing levels of atypia.
DermTech, Inc. is a molecular diagnostic company. The Company is engaged in developing and marketing non-invasive genomics tests to aid in the diagnosis and management of melanoma. Its technology enhances evaluation of lesions suspicious for melanoma using non-invasive sample collection and detecting genomic markers associated with melanoma to identify higher risk lesions or rule out melanoma with a 99% or higher negative predictive value (NPV). It offers DermTech Melanoma Test (the DMT), which is a non-invasive way to enhance evaluation of pigmented lesions suspicious for melanoma. Its genomics platform has been designed to work with its Smart Sticker, which provides an easy and non-invasive way to collect a skin sample, in contrast to the existing standard of care of using a scalpel to biopsy suspicious lesions. It also provides its research services and technology platform on a contract basis to pharmaceutical companies that use the technology to support their clinical trials.
DERMTECH, INC. 
