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

Laura K. Ferris, Darrells Rigel, Danielm Siegel, Maralk Skelsey, Garyl Peck, Catherine Hren, Christopher Gorman, Tana Frumento, Burkhard Jansen, Zuxu Yao, Jim Rock, Stevan R. Knezevich, Clay J Cockerell

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number2
JournalDermatology Online Journal
Volume25
Issue number5
StatePublished - May 1 2019

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Registries
Melanoma
Dermatology
Gene Expression
Unnecessary Procedures
Dermatologists

Keywords

  • Clinical utility
  • Gene expression
  • Melanoma
  • Noninvasive
  • Pigmented
  • Rule-out test

ASJC Scopus subject areas

  • Dermatology

Cite this

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, Darrells; Siegel, Danielm; Skelsey, Maralk; Peck, Garyl; Hren, Catherine; Gorman, Christopher; Frumento, Tana; Jansen, Burkhard; Yao, Zuxu; Rock, Jim; Knezevich, Stevan R.; Cockerell, Clay J.

In: Dermatology Online Journal, Vol. 25, No. 5, 2, 01.05.2019.

Research output: Contribution to journalArticle

Ferris, LK, Rigel, D, Siegel, D, Skelsey, M, Peck, G, Hren, C, Gorman, C, Frumento, T, Jansen, B, Yao, Z, Rock, J, Knezevich, SR & Cockerell, CJ 2019, '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', Dermatology Online Journal, vol. 25, no. 5, 2.
Ferris, Laura K. ; Rigel, Darrells ; Siegel, Danielm ; Skelsey, Maralk ; Peck, Garyl ; Hren, Catherine ; Gorman, Christopher ; Frumento, Tana ; Jansen, Burkhard ; Yao, Zuxu ; Rock, Jim ; Knezevich, Stevan R. ; Cockerell, Clay J. / 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. In: Dermatology Online Journal. 2019 ; Vol. 25, No. 5.
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abstract = "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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