DermTech’s Pigmented Lesion Assay (PLA) assesses gene expression consistent with melanoma and can aid in the clinician’s biopsy decision. The PLA development involved over 500 lesion samples including over 250 melanomas. The expression profile was developed by screening the entire genome for differential gene expression between melanoma and non-melanoma pigmented skin lesions (British Journal of Dermatology, 2011).
In two validation studies comparing the 2-gene expression profile to histopathology diagnosis (n=398), the Pigmented Lesion Assay demonstrated 91% accuracy in identifying non-melanoma and melanoma lesions, with a sensitivity of 91% and a specificity of 69%. At a projected melanoma prevalence of 7%, the negative predictive value was greater than 99%. Studies show that the current standard clinical assessment of pigmented lesions demonstrates an accuracy of less than 20% with sensitivities ranging from 70-80% and specificities ranging from 5-20%. 1,2,3
The DermTech Pigmented Lesion Assay provides information on gene expression associated with melanoma. The test is intended for use on pigmented lesions suspicious for melanoma that meet at least one of the ABCDE criteria for which the clinician would like additional information prior to surgical biopsy. The test has been validated in samples collected using the Adhesive Skin Biopsy Kit, distributed by DermTech and used according to the instructions for use.
Instructions for Use