PUBLICATIONS
Pigmented Lesion Assay Publications
The American Journal of Dermatopathology | A Retrospective Review: Our Experience With an Adhesive-Based Pigmented Lesion Assay Used to Evaluate Cutaneous Lesions Suspicious for Melanoma
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.
JAAD | Clinical Performance of a Noninvasive Melanoma Rule-Out Test Across Fitzpatrick Skin Types
Numerous studies suggest that melanoma in individuals with higher Fitzpatrick skin types (FST) is more likely to present at an advanced stage and result in higher mortality. A non-invasive genomic rule-out test assessing gene expression of LINC00518 and PRAME has been introduced to help augment detection of melanoma at an early stage while reducing the number of biopsies performed for benign pigmented lesions that simulate melanoma.
JDD: Genomic Analysis Aids in the Management of Dermoscopically Atypical Pigmented Lesions
Clinical and dermoscopic features alone could not differentiate MIS from ATN. Non-invasive genomic testing helped differentiate lower from higher-risk lesions and aid in clinical management decisions. Genomic testing was particularly helpful in patients with large numbers of lesions with several being considered for biopsy based on clinical and dermoscopic examination.
SKIN: Real-World Performance of a Noninvasive Cutaneous Melanoma Rule-Out Test: A Multicenter U.S. Registry Study
Non-invasive adjuncts to visual assessment of pigmented lesions may reduce biopsies of benign lesions without compromising melanoma detection. A non-invasive genomic melanoma rule-out assay analyzes RNA extracted from stratum corneum cells for PRAME and LINC00518, two genes commonly expressed in melanomas but less often in benign lesions. This study sought to characterize performance of this test in a large patient cohort tested in the real-world clinical setting.
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.
JDD: Real-world utility of a non-invasive gene expression test to rule out primary cutaneous melanoma: a large US registry study
Efforts to unambiguously assess and adjudicate primary melanocytic skin lesions clinically suspicious of melanoma to rule out melanoma via the existing standard of care of visual assessment and histopathology remains a challenge even for pigmented lesion experts because of inherent limitations of image recognition.
JAAD: Use of the Pigmented Lesion Assay to rapidly screen a patient with numerous clinically atypical pigmented lesions
The goal of early melanoma detection is to biopsy melanomas before they become invasive and avoid unnecessary biopsies of benign pigmented lesions.1 Noninvasive gene expression profile testing has the potential to serve both purposes by improving clinical diagnostic accuracy and informing biopsy decision making. The Pigmented Lesion Assay (PLA) (DermTech, La Jolla, CA) involves tape-stripping lesions to obtain stratum corneum from which RNA is isolated and expression levels of the noncoding long RNA Linc00518 (Linc) and PRAME genes are assessed.
Findings from a large US registry study to assess the real-world utility of a non-invasive gene expression test designed to rule out primary cutaneous melanoma
The Pigmented Lesion Assay (PLA) analyzes gene expression to objectively rule out melanoma. The test uses a non-invasive adhesive patch–based sample collection platform that enables guidance on biopsy decisions and elevates pigmented lesion management beyond what can be visually ascertained. The test’s negative predictive value of >99%, and rapid, painless application make it an attractive pre-biopsy solution. It reduces biopsies by 90% while improving care and reducing cost.
Dermatology Online Journal: Impact on clinical practice of a non-invasive gene expression melanoma rule-out test: 12-month follow-up of negative test results and utility data from a large US registry study
The Pigmented Lesion Assay (PLA, sensitivity 91-95%, specificity 69-91%, negative predictive value >99%) is a commercially available, non-invasive gene expression test that helps dermatologists guide pigmented lesion management decisions and rule out melanoma. Earlier studies have demonstrated high clinical utility and no missed melanomas in a 3-6-month follow-up period. We undertook the current investigations to provide 12-month follow-up data on PLA(-) tests, and to further confirm utility…
Melanoma Research: Real-world performance and utility of a noninvasive gene expression assay to evaluate melanoma risk in pigmented lesions
About 3 million surgical pigmented skin lesion biopsies are performed each year in the USA alone to diagnose fewer than 200 000 new cases of invasive melanoma and melanoma in situ using the current standard of care that includes visual assessment and histopathology. A recently described noninvasive adhesive patch-based gene expression rule-out test [pigmented lesion assay (PLA)] may be helpful in identifying high-risk pigmented skin lesions to aid with surgical biopsy decisions.
Development and Validation of a Non-Invasive 2-Gene Molecular Assay for Cutaneous Melanoma
A 2-gene classification method based on LINC00518 and preferentially expressed antigen in melanoma (PRAME) gene expression was evaluated and validated in 555 pigmented lesions (157 training and 398 validation samples) obtained noninvasively via adhesive patch biopsy. Results were compared with standard histopathologic assessment in lesions with a consensus diagnosis among 3 experienced dermatopathologists.