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" 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 "
Ferris, Laura K.; Rigel, Darrell S.; Siegel, Daniel M; Skelsey, Maral K; Peck, Gary L.; Hren, Catherine; Gorman, Christopher; Frumento, Tana; Jansen, Burkhard; Yao, Zuxu; Rock, Jim; Knezevich, Stevan R; Cockerell, Clay J
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AL
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| Record Number
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924580
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LA61w6h7mn
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| Language of Document
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English
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| Main Entry
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Ferris, Laura K.; Rigel, Darrell S.; Siegel, Daniel M; Skelsey, Maral K; Peck, Gary L.; Hren, Catherine; Gorman, Christopher; Frumento, Tana; Jansen, Burkhard; Yao, Zuxu; Rock, Jim; Knezevich, Stevan R; Cockerell, Clay J
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| Title & Author
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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 [Article]\ Ferris, Laura K.; Rigel, Darrell S.; Siegel, Daniel M; Skelsey, Maral K; Peck, Gary L.; Hren, Catherine; Gorman, Christopher; Frumento, Tana; Jansen, Burkhard; Yao, Zuxu; Rock, Jim; Knezevich, Stevan R; Cockerell, Clay J
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Dermatology Online Journal
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25/5
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2019
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| Abstract
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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. A 12-month chart review follow-up of 734 pigmented lesions that had negative PLA results from 5 US dermatology centers was performed. Thirteen of these lesions (1.8%) were biopsied in the follow-up period and submitted for histopathologic review. None of the lesions biopsied had a histopathologic diagnosis of melanoma. The test's utility was studied further in a registry (N=1575, 40 US dermatology offices, 62 participating providers), which demonstrated that 99.9% of PLA(-) lesions were clinically monitored, thereby avoiding a surgical procedure, and 96.5% of all PLA(+) lesions were appropriately biopsied, most commonly with a tangential shave. This long-term follow-up study confirms the PLA's high negative predictive value and high utility in helping guide the management of pigmented lesions to avoid unnecessary surgical procedures.
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