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Response to Marchetti et al.

      Recently,
      • Marchetti M.A.
      • Nanda J.K.
      • Mancebo S.E.
      • Dusza S.W.
      Real-world application of a noninvasive two-gene expression test for melanoma diagnosis [e-pub ahead of print].
      used decision-curve analysis and hypothetical models of melanoma biopsy prevalence to retrospectively evaluate the clinical utility of the two Gene Expression Profile Pigmented Lesion Assay (PLA) (DermTech, San Diego, CA). Although the further evaluation of the PLA is appreciated, significant concerns exist regarding material flaws in
      • Marchetti M.A.
      • Nanda J.K.
      • Mancebo S.E.
      • Dusza S.W.
      Real-world application of a noninvasive two-gene expression test for melanoma diagnosis [e-pub ahead of print].
      ’s analyses and characterizations. These include (i) incorrectly characterizing the PLA as a test for melanoma diagnosis, (ii) significant challenges within the hypothetical models used and the data input and interpretations employed, and (iii) erroneous assumptions and implications that the social cost of not biopsying a melanoma is equivalent to performing an unneeded biopsy.

      Abbreviation:

      PLA (Pigmented Lesion Assay)
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        • Marchetti M.A.
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        Real-world application of a noninvasive two-gene expression test for melanoma diagnosis [e-pub ahead of print].
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      Linked Article

      • Real-World Application of a Noninvasive Two-Gene Expression Test for Melanoma Diagnosis
        Journal of Investigative DermatologyVol. 141Issue 9
        • Preview
          A two-gene noninvasive molecular test (pigmented lesion assay [PLA], DermTech, La Jolla, CA) for the diagnosis of melanoma is commercially available in the United States. The test measures gene expression for LINC00518 and PRAME from stratum corneum samples (Gerami et al., 2017). However, the 2017 validation study and 2018 registry study provided different estimates of the test’s diagnostic accuracy (sensitivity of 91–95% and specificity of 53–91%) (Ferris et al., 2018; Gerami et al., 2017). The factors that contribute to different estimates of the PLA’s diagnostic accuracy are not well characterized, which has raised concerns about its validity and potential for harm (Beatson and Weinstock, 2019).
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