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Publications

Pigmented Lesion Assay

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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JAMA Letter 2019

We appreciate the comments by Beatson and Weinstock on our analysis of the pigmented lesion assay (PLA). We agree that it is important to develop tools that have the potential to help decrease biopsies of benign pigmented skin lesions such as the PLA, a gene expression melanoma rule-out test based on obtaining skin samples noninvasively via adhesive patches…

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Noninvasive Analysis of High-Risk Driver Mutations and Gene Expression Profiles in Primary Cutaneous Melanoma

Tools that help reduce the number of surgical biopsies performed on benign lesions have the potential to improve patient care. The pigmented lesion assay (PLA) is a noninvasive tool validated against histopathology that helps rule out melanoma and the need for surgical biopsies of atypical pigmented skin lesions. Genetic information is collected using adhesive patches and the expression of two genes, LINC and PRAME, is measured. By using genetic material collected noninvasively and to further validate the PLA, somatic hotspot mutations in genes known to be drivers of early melanoma development (BRAF other than V600E, NRAS, and the TERT promoter) can also be identified…

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Skin Therapy Letter: Non-Invasive Gene Expression Testing to Rule Out Melanoma

The Pigmented Lesion Assay (PLA) is a gene expression test that helps rule out melanoma and has the potential to reduce the need for surgical biopsies of atypical pigmented skin lesions. Utilizing a new technological platform for the non-invasive profiling of skin, the assay analyzes samples collected from adhesive patches for expression of two key genes (PRAME and LINC00518) known to be overexpressed in melanoma.

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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.

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JAMA: Economic Analysis of a Noninvasive Molecular Pathologic Assay for Pigmented Skin Lesions

Question: What are the economic implications of using a noninvasive gene expression test (the pigmented lesion assay) to rule out melanoma and the need for surgical biopsy of atypical pigmented lesions suggestive of melanoma? Findings: In this cost-savings analysis of the pigmented lesion assay using model inputs for patients with pigmented lesions suggestive of melanoma, a $447 (47%) cost reduction per assessed pigmented lesion vs the current histopathologic standard of care was achievable if the assay was priced at $500.

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