A new clinical study confirms the clinical utility of the DermTech’s pigmented lesion assay (PLA)in the early detection of melanoma. 

The PLA is a non-invasive test that uses molecular gene expression to identify malignant changes in a skin sample collected with adhesive patches. With a demonstrated negative predictive value of 99%, the PLA significantly reduces the probability of missing melanoma to less than 1%, DermTech says.

In a study led by Laura K. Ferris, MD, PhD, of the University of Pittsburgh Medical Center, investigators assessed long-term follow-up after a negative PLA test result. Twelve-month data confirmed the PLA’s high negative predictive value.  

Data from a patient registry also reported in the study further substantiated the impact of the PLA on clinical decision making. Data collected from 1,575 patients from 62 providers across 40 US dermatology offices in a real world setting indicated 1,433 PLA negative tests, of which 1,431 (99.9%) were not biopsied during 12 months of follow-up. Of the 142 PLA positive tests identified through the registry, 137 (96.5%) were subsequently biopsied, thus suggesting that physicians use the test results to guide their biopsy decisions.