Publications

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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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.

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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.

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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.

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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.

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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…

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