A Retrospective Review: Our Experience With an Adhesive-Based Pigmented Lesion Assay Used to Evaluate Cutaneous Lesions Suspicious for Melanoma.

Abstract

Background: Being one of the largest dermatology groups in the country with an in-house pathology laboratory, we have seen a significant increase in the number of adhesive-based pigmented lesion assays (ABPLAs) in addition to biopsies and excisions following a moderate-risk or high-risk result with this test.

Objective: To report our clinical experience and independently confirm that our results with this ABPLA (Pigmented lesion assay, DermTech. San Diego, CA) are consistent with the results of the validation studies completed by the test manufacturer.

Methods: A retrospective review of our electronic medical records for results of ABPLAs, corresponding histopathologic results and available clinical follow-up, along with their statistical analysis was completed.

Results: After reviewing our electronic medical records, we found that 893 ABPLAs for pigmented lesions concerning for melanoma were obtained in a period of 14 months. Of the 893 ABPLAs completed, 161 biopsies and excisions were performed after the initial results of these assays. Additional clinical follow-up data were recorded and used for the statistical analysis of the performance and accuracy of this test.

Limitations: The small number of lesions reported as low risk for melanoma with corresponding histopathologic results limits our evaluation of the performance of this test. In addition, there may have been some melanomas that were not identified because the duration of the clinical follow-up was insufficient or because some patients were lost to follow-up.

Conclusion: In our experience this ABPLA has a sensitivity of 92.0%, a specificity of 79.5%, a positive predictive value of 16.9%, and a negative predictive value of 99.5% for the detection of melanoma.