DermTech Pigmented Lesion Assay (PLA) to Enrich Melanoma Positivity Nearly Five-Fold in Biopsied Lesions: Findings from a Large US Registry
LA JOLLA, Calif.: DermTech, Inc., a leader in precision dermatology enabled by a non-invasive skin genomics platform, has announced that SKIN has published the results of a large registry study finding that the evaluation of genomic atypia using DermTech’s Pigmented Lesion Assay (the “PLA”) 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.
The published findings in SKIN can be found here: https://jofskin.org/index.php/skin/article/view/1146
Dr. Brook Brouha, M.D., Ph.D., the study’s lead author commented, “I start every skin exam with a visual clinical inspection. When I find difficult borderline lesions, the PLA’s objective genomic information informs my treatment decision. I now detect more early-stage melanomas with fewer invasive procedures.”
“There is clear patient and clinician benefit when genomic atypia information is added to visual inspection to guide biopsy decisions and enhance early melanoma detection. Patients love the additional peace of mind that the high performance of the PLA offers, and they also appreciate not being cut when avoidable,” added Burkhard Jansen, M.D., DermTech’s chief medical officer.
