Publications

JCAD: Genomic Evaluation of Clinically Ambiguous Pigmented Lesions

The clinical evaluation of pigmented lesions represents a ‘high-stakes’ scenario as a missed melanoma can be fatal. Traditional clinical assessment visually sorts pigmented lesions into those that merit a biopsy and those that do not. In our practice there exists a group of lesions judged to not merit biopsy where melanoma, while very unlikely, cannot be excluded with absolute certainty.

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Concordance of Preferentially Expressed Antigen in Melanoma by Non-Invasively Collected Polymerase Chain Reaction and Immunohistochemistry on Paraffin Embedded Tissue

There is a higher concordance with PCR when PRAME is positive by IHC than when it is negative by IHC. When PRAME is positive by IHC, it is usually also positive by PCR (87.5% concordance in this analysis). In contrast, the concordance rate when PRAME is negative by IHC is 54.8%. This suggests the DMT frequently detects PRAME expression that is below the level detectable by IHC.This difference in concordance rates maybe explained by the higher sensitivity of PCR compared to IHC.

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SKIN: Cost-Benefit Analysis of the Pigmented Lesion Assay When Introduced Into the Visual Assessment / Histopathology Pathway for Lesions Clinically Suspicious for Melanoma

The OptumInsights study demonstrates the economic value of the DermTech® Pigmented Lesion Assay (PLA) in the assessment of uncertain pigmented lesions to rule out melanoma. When the DermTech PLA is introduced into the current care pathway to guide pigmented lesion management decisions, the Optum model demonstrates $5.66 million in net savings, for a plan of 1 million commercial members.

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SKIN: Non-Invasive Detection of Genomic Atypia Increases Real-World NPV and PPV of the Melanoma Diagnostic Pathway and Reduces Biopsy Burden

Management of pigmented lesions currently relies on visual assessment with surgical biopsy and histopathologic examination for those lesions suspicious for melanoma. A non-invasive genomic assay that detects two melanoma-associated biomarkers (PLA, 2-GEP) has recently been validated as an adjunct to visual assessment for distinguishing high-risk pigmented lesions appropriate for biopsy from those that can be safely monitored via clinical surveillance.

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Long-term outcome of pigmented lesions clinically suspicious for melanoma previously tested with the Pigmented Lesion Assay (PLA): results from the TRUST Study

The assessment of pigmented lesions suspicious for melanoma remains a challenge. The non-invasive Pigmented Lesion Assay (PLA) guides biopsy decisions and detects melanoma at its earliest stages based on genomic atypia. The TRUST Study was designed to determine the proportion of true negative lesions among those that initially tested negative. Of the 1781 lesions in the long-term follow-up screening cohort, there were no known melanoma deaths or late-stage melanoma detected.

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Non-Invasively Stratifying Atopic Dermatitis Patients Based on Inflammatory Genes

Atopic dermatitis (AD) is a chronic inflammatory disease characterized by significant barrier disruption and intense pruritus. In recent years, there has been a growing number of targeted therapies in clinical development with a predominant focus on antagonizing Th2-mediated inflammation; however, these therapies are effective (IGA 0/1) in less than 50% of AD patients.

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