LA JOLLA, Calif.--(BUSINESS WIRE)--DermTech, Inc., a molecular genomics company pioneering precision dermatology, announces the publication of a new clinical study, confirming the clinical utility of the pigmented lesion assay (PLA) in the early detection of melanoma.
The PLA is a breakthrough, 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%.
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 follow-up data confirm the PLA’s high clinical utility and high negative predictive value. Clinicians follow the guidance of the test and rely on it during long-term follow-up. PLA negative lesions are monitored clinically and generally not biopsied, avoiding unnecessary surgical procedures; PLA positive lesions are biopsied as intended," commented Dr. Ferris.
Data from a patient registry also reported in the study, further substantiated the impact of the PLA on clinical decision making. Data collected from 1575 patients from 62 providers across 40 U.S. dermatology offices in a real world setting indicated 1433 PLA negative tests, of which 1431 (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.
"The results of this study confirm that the PLA transforms the current diagnostic pathway from one that is subjective, invasive and of low accuracy to one that is objective, non-invasive and highly accurate," said Dr. Maral Skelsey.
“This study again supports the PLA’s high utility and high negative predictive value in the assessment of pigmented lesions clinically suspicious for melanoma. The PLA offers enhanced early detection by measuring malignant changes in gene expression that can’t be identified clinically or with histopathology, thereby reducing the probability of missing melanoma to <1%,” said John Dobak, MD, Chief Executive Officer of DermTech.
The study, "Impact on Clinical Practice of a Non-Invasive Gene Expression Melanoma Rule-Out Test: 12-Month Follow-Up of Negative Test Results and Utility Data From a Large US Registry Study," is published in Dermatology Online Journal and can be viewed online here: https://escholarship.org/uc/item/61w6h7mn
DermTech is the global leader in precision dermatology. Our mission is to transform the practice of dermatology through more accurate diagnosis and treatment and the elimination of unnecessary surgery, leading to improved patient care and lower costs. DermTech analyzes skin biopsy samples collected non-invasively using an adhesive patch rather than a scalpel. We market and develop products that facilitate the early detection of skin cancers, assess inflammatory diseases, and customize drug treatments. For additional information visit: dermtech.com.