DermTech Launches DermTech PLAplus
DermTech has launched DermTech PLAplus (TM), its next generation test for the enhanced early detection of melanoma, intended to provide objective and actionable information to guide clinical management decisions for skin lesions suspicious of melanoma.
PLAplus 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 percent to 97 percent and maintain a negative predictive value of >99 percent, resulting in a less than one percent probability of missing melanoma. 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,” says Laura Ferris, MD, PhD, 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. “Having additional genomic information to objectively assess disease risk beyond what can be ascertained visually can help physicians make an earlier, more accurate diagnosis.”
“DermTech is thrilled about the addition of DNA TERT promoter mutation analyses to our test menu for the enhanced early detection of melanoma,” says Claudia Ibarra, chief operating officer at DermTech. “As always, it is our commitment to deliver high quality testing and laboratory services to our patients and clinicians, and PLAplus is a prime example of this.”
The National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology recognize the use of pre-diagnostic non‑invasive genomic patch testing for melanoma, like the DermTech PLATM, to help guide biopsy decisions for lesions suspicious of melanoma. There are over 21 peer reviewed publications summarizing its clinical validity and utility of the DermTech PLATM in studies of over 7,000 patients.