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Melanoma
Non-Melanoma Skin Cancer
Inflammatory Diseases
Microbiome
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.