A new 2-gene pigmented lesion test that classifies skin lesions as melanoma or nonmelanoma could help with diagnostic challenges physicians frequently face with the visual image and pattern recognition approach. 

Accurate clinical and histopathological analysis of pigmented skin lesions is difficult even for experts. Accurate, noninvasive diagnostic techniques could help in skin cancer diagnoses.

In this study, researchers created a 2-gene classification approach based on LINC00518 and preferentially expressed antigen in melanoma (PRAME) gene expression levels. Researchers then validated this method in 555 pigmented lesions, 157 of which were training lesions and 398 of which were validation samples. Clinicians retrieved these samples noninvasively by adhesive patch biopsy. 

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This study compared results with standard histopathologic analyses in lesions with a consensus diagnosis among 3 expert dermatopathologists.

In the 398 validation samples, 87 samples were melanomas and 311 were nonmelanomas. This 2-gene approach with LINC00518 and/or PRAME detection distinguished melanoma from nonmelanoma with 91% sensitivity and 69% specificity.

Researchers validated this approach in adhesive patch melanoma samples, underlying formalin-fixed, paraffin-embedded samples of surgically excised primary melanomas, and in melanoma lymph node metastases

This approach cannot be used on mucous membranes, on the palms of hands, or on the soles of feet.


1. Gerami P, Yao Z, Polsky D, et al. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017;76(1):114-120.e2