LA JOLLA, Calif.--(BUSINESS WIRE)--DermTech, Inc., the global leader in non-invasive molecular dermatology, announced today the publication of “Real-world performance and utility of a noninvasive gene expression assay to evaluate melanoma risk in pigmented lesions,” by Dr. Laura Ferris of the University of Pittsburgh, et al, in Melanoma Research. The main objective of this clinical study was to determine the real-world clinical performance of PLA use and to assess how the PLA improves patient outcomes. In an analysis of 381 patients assessed with the PLA, 100% of PLA (+) test results were clinically managed with surgical biopsy, while 99% of PLA (-) cases were clinically managed with surveillance. No missed melanomas were identified in the 6-9 month follow up period after a negative PLA test. The number of surgical biopsies needed to find one melanoma was 2.7 with the PLA versus ~25 for the current standard of care, demonstrating a near 10-fold reduction in surgical procedures. For the 19 melanomas found in the PLA(+) cohort, all were melanoma in situ or Stage 1a, demonstrating the PLA identifies melanoma at the earliest stages when it is entirely curable by wide excision. A high clinical performance of the PLA was demonstrated from this data with an estimated 95% sensitivity and 91% specificity.
“We knew we had a very well validated non-invasive melanoma rule-out test with a negative predictive value of over 99%. Preliminary utility data from an earlier reader study showed that dermatologists biopsy less often while detecting more early-stage melanomas when using DermTech’s pigmented lesion assay. This study now confirms similar exceptional utility in the real-world. The PLA effectively helps clinicians manage pigmented lesions, by avoiding unnecessary biopsies while identifying early melanoma. Consistent with the high NPV of the test, there were no missed melanomas in the follow up period,” said Dr. Laura Ferris.
DermTech is the global leader in molecular dermatology, bringing precision medicine to the diagnosis and treatment of skin disease. We market and develop products that facilitate the early detection of skin cancers, assess inflammatory diseases, and customize drug treatments. DermTech analyzes skin biopsy samples collected non-invasively using an adhesive patch rather than a scalpel. Our mission is to transform dermatology by delivering highly accurate and objective information to the clinician to improve care and reduce costs and to pharma partners to support the development of targeted therapeutics. For additional information visit dermtech.com.