Pigmented Lesion Assay

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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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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JAMA Letter

Not missing melanomas in daily practice keeps dermatologists up at night and is a challenge even for dermatologists who see pigmented lesion cases regularly.

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