Real-world performance and utility of a noninvasive gene expression assay to evaluate melanoma risk in pigmented lesions

Melanoma Research
Laura K FerrisDaniel M Siegel

Abstract

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. The main objective of this utility study was to determine the real-world clinical performance of PLA use and assess how the PLA changes physician behavior in an observational cohort analysis of 381 patients assessed with the PLA. All (100%) of 51 PLA(+) test results were clinically managed with surgical biopsy. Of these, 19 (37%) were melanomas, corresponding to a number needed to biopsy of 2.7 and a biopsy ratio of 1.7. All melanomas were histopathologically classified as melanoma in situ or stage 1. Nearly all (99%) of 330 PLA(-) test results were clinically managed with surveillance. None of the three follow-up biopsies performed in the following 3-6 months, were diagnosed as melanoma histopathologically. The estimated sensitivity and specificity of ...Continue Reading

References

Apr 19, 2005·Proceedings of the National Academy of Sciences of the United States of America·Christopher HaqqMohammed Kashani-Sabet
Jul 16, 2011·The Journal of Dermatological Treatment·Rebekah L WilsonAlan B Fleischer
Sep 30, 2014·Journal of the American Academy of Dermatology·Lauren StrazzulaDaniela Kroshinsky
Aug 10, 2016·Assay and Drug Development Technologies·Zuxu YaoBurkhard Jansen
Oct 7, 2016·Journal of the American Academy of Dermatology·Pedram GeramiLaura K Ferris

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Citations

Jan 31, 2019·JAMA Dermatology·Daniel M Siegel, John Hornberger
Oct 23, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Prathamesh M KulkarniYvonne M Saenger
Jan 13, 2021·Journal of Cutaneous Pathology·Mary E LohmanJeffrey P North
May 4, 2020·Journal of the American Academy of Dermatology·Lauren FriedJennifer A Stein
Feb 23, 2021·Bioinformatics and Biology Insights·Mozhdeh Shahmoradi, Zahra Rezvani
Mar 22, 2021·The Journal of Investigative Dermatology·Michael A MarchettiStephen W Dusza
Jul 18, 2021·The Journal of Investigative Dermatology·Michael A Marchetti, Stephen W Dusza
Jul 18, 2021·The Journal of Investigative Dermatology·Darrell S RigelBurkhard Jansen

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Methods Mentioned

BETA
biopsy
biopsies

Software Mentioned

R
Excel

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