New Publications
PLA Publications
Winter Clinical Miami: Large US Registry Study Confirms 2-GEP Negative Predictive Value Over 99%
The Trust 2 Study results reaffirm the DMT’s real-world clinical utility to rule out melanoma with a negative predictive value (NPV) that is higher than other currently available methods. As a non-invasive test that has demonstrated an NPV of 99% or higher in multiple, large studies, the DMT provides actionable genomic information for a suspicious pigmented lesion.
Non-invasive Gene Expression Analysis Rules Out Melanoma with High Negative Predictive Value Regardless of Skin Phototype
The performance of the 2-GEP assay in patients with Fitzpatrick skin types IV-VI did not differ from its performance in patients with Fitzpatrick skin types I-III. Sensitivity and specificity were 90% or higher in both groups, and most importantly, the NPV for each group was greater than 99%.
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.
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.
Journal of Dermatology for Physician Assistants: A Non-invasive Technique for Detecting Melanoma
Advances in genomic technology have allowed providers to evaluate pigmented lesions with greater reliability. Using all available methods to evaluate changing lesions has led to earlier detection and actionable results.
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.
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.
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.
SKIN: Genomic Atypia to Enrich Melanoma Positivity in Biopsied Lesions: Gene Expression and Pathology Findings From a Large U.S. Registry Study
Importance: Melanoma is diagnosed in approximately 200,000 people within the US each year and is responsible for more than 6,850 deaths. Currently, clinical suspicion guides biopsy decisions and melanoma is confirmed in approximately 4% of biopsied lesions. A non-invasive two-gene expression test (2-GEP) was shown to enhance the physical exam by evaluating genomic atypia to guide biopsy decisions. This study examines the corresponding histopathology of real-world 2-GEP-positive cases.
SKIN: Caring for Melanoma Survivors with Self-Detected Concerning Moles During COVID-19 Restricted Physician Access: a Cohort Study
Background: Physician appointments for non-essential care ceased during COVID-19. Objective: To pilot test a telehealth solution for patients to rule out melanomas and need for surgical biopsies based on genomic analyses of pigmented lesion samples obtained via adhesive patches. Methods: Surveys assessed SSE anxiety. Under remote clinician guidance, patients or partners obtained samples using adhesive patches (DermTech, La Jolla, CA). Results: SSE anxiety increased. Guided self-sampling led to molecular risk factor analyses in 7/7 (100%) of cases compared to 9/10 (90%) randomly selected physician-sampled control cases. Conclusions: Adhesive patch self-sampling under remote physician guidance is a viable specimen collection option.