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. 2017 Jul 1;153(7):675-680.
doi: 10.1001/jamadermatol.2017.0473.

Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy

Laura K Ferris  1 , Burkhard Jansen  2 , Jonhan Ho  1 , Klaus J Busam  3 , Kenneth Gross  4 , Doyle D Hansen  5 , John P Alsobrook 2nd  2 , Zuxu Yao  2 , Gary L Peck  6 , Pedram Gerami  7
Affiliations

Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy

Laura K Ferris et al. JAMA Dermatol. .

Abstract

Importance: Expression of long intergenic non-protein coding RNA 518 (LINC00518) and preferentially expressed antigen in melanoma (PRAME) genes, obtained via noninvasive adhesive patch biopsy, is a sensitive and specific method for detection of cutaneous melanoma. However, the utility of this test in biopsy decisions made by dermatologists has not been evaluated.

Objective: To determine the utility of the pigmented lesion assay (PLA) for LINC00518/PRAME expression in decisions to biopsy a series of pigmented skin lesions.

Design, setting, and participants: In this secure web-based, multiple-reader-multiple-case study, 45 board-certified dermatologists each evaluated 60 clinical and dermoscopic images of clinically atypical pigmented lesions, first without and then with PLA gene expression information and were asked whether the lesions should be biopsied. Data were collected from March 24, 2014, through November 13, 2015.

Interventions: Participants were given a report for each lesion, which included the results of an assay for expression of LINC00518/PRAME and a PLA score with data on the predictive values of the information provided.

Main outcomes and measures: Biopsy sensitivity and specificity with vs without PLA data.

Results: Forty-five dermatologists (29 male and 16 female) performed the evaluation. After incorporating the PLA into their decision as to whether to biopsy a pigmented lesion suggestive of melanoma, dermatologists improved their mean biopsy sensitivity from 95.0% to 98.6% (P = .01); specificity increased from 32.1% to 56.9% (P < .001) with PLA data.

Conclusions and relevance: The noninvasive PLA enables dermatologists to significantly improve biopsy specificity while maintaining or improving sensitivity. This result may increase the number of early melanomas biopsied and reduce the number of benign lesions biopsied, thereby improving patient outcomes and reducing health care costs.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs Ferris, Hansen, Alsobrook, Peck, and Gerami report serving as consultants to DermTech, Inc. Drs Jansen and Yao report employment by DermTech, Inc. Drs Jansen, Alsobrook, and Yao report stock ownership or options in DermTech, Inc. No other disclosures were reported.

Figures

Figure.
Figure.. Mean Reader Accuracy With and Without Use of the Pigmented Lesion Assay (PLA)
Accuracies in phase A (without the PLA) and phase B (with the PLA) are shown. Each symbol represents the mean accuracy of 1 individual reader for all 60 cases. The mean accuracies of 40.4% (phase A) and 62.4% (phase B) are indicated by arrows (P < .001).
See this image and copyright information in PMC

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