eClinical Technology and Industy News


Excerpt from the Press Release:

LA JOLLA, Calif.–(BUSINESS WIRE)–Apr. 22, 2021– DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today the launch of DermTech PLAplusTM, its next generation test for the enhanced early detection of melanoma. PLAplusdelivers objective and actionable information to guide clinical management decisions for skin lesions suspicious of melanoma.

The new PLAplus test adds TERT (Telomerase Reverse Transcriptase) promoter DNA driver mutation analyses to the current RNA gene expression based Pigmented Lesion Assay (PLA), which includes LINC00518 and PRAME. TERT is individually associated with histopathologic features of aggressiveness and poor survival in melanoma. The combined tests (LINC00518 and PRAME, plus TERT) elevate the sensitivity from 91%1 to 97% and maintain a negative predictive value of >99%, resulting in a less than 1% probability of missing melanoma2,3. By combining RNA gene expression and DNA mutation analyses, PLAplus provides a highly accurate non-invasive genomic test for enhanced early melanoma detection.

“Identifying melanoma at its earliest stages provides patients with the highest cure rate, and TERT promoter mutations are independently associated with poor overall survival and more aggressive disease,” said Laura Ferris, M.D., Ph.D., Associate Professor, Dermatology, University of Pittsburgh and senior author of Risk Stratification of Severely Dysplastic Nevi by Non-Invasively Obtained Gene Expression and Mutation Analyses.2 “Having additional genomic information to objectively assess disease risk beyond what can be ascertained visually can help physicians make an earlier, more accurate diagnosis.”

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