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High negative predictive value of >99% suggests role

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greens12   Thursday, 05/21/20 12:50:04 AM
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High negative predictive value of >99% suggests role for DermTech PLA as a non-invasive rule-out tool for melanoma

LA JOLLA, Calif.--(BUSINESS WIRE)--May 20, 2020-- DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, today announced that the DermTech Pigmented Lesion Assay (the “DermTech PLA”) is reviewed in the Journal of the American Academy of Dermatology (“JAAD”) by leading dermatologists at the New York University School of Medicine as one of four novel molecular technologies with the potential to address current gaps in melanoma management through improved diagnostic accuracy and prognostication. Since its launch in 2016, the DermTech PLA, DermTech’s non-invasive adhesive patch test for melanoma detection, has been used to assess more than 50,000 lesions and remains the first and only non-invasive gene expression test in dermatology, providing objective genomic data to help guide clinical decisions.

The article published in JAAD summarizes a review of four molecular technologies that analyze skin cells and inherited genetic variations as adjunct tools for melanoma management, providing a comprehensive, evidence-based foundation for clinicians regarding the management of difficult pigmented lesions. The review examined the fundamental principles behind each test, peer-reviewed literature assessing tool performance, and the utility and limitations of each assay. The published summary cites six peer-reviewed studies of the DermTech PLA. Key points from the article in reference to the DermTech PLA include:

The DermTech PLA’s high negative predictive value (“NPV”) of >99% suggest a role as a rule-out tool for melanoma, providing clinicians with additional information to reduce biopsies of benign lesions
The molecular test measures the levels of PRAME and LINC00518, two genes preferentially identified in melanoma
The non-invasive adhesive patch removes only the outermost layers of the stratum corneum and does not impact future histologic examination of the underlying epidermis
Reduction of unnecessary biopsies not only decreases patient morbidity but may reduce costs to the overall healthcare system
Physician follow-up within 6-12 months on negative results, per standard of care, should mitigate any remaining risk of missed melanoma(s)

“This review underscores the growing importance of genomic information and objective diagnostic tools in melanoma diagnosis. The revolution in cancer care brought about by genomics is beginning to take hold in dermatology, and DermTech is at the forefront of this change,” said John Dobak, M.D., Chief Executive Officer of DermTech. “Early melanoma detection is very challenging, and the DermTech PLA can reduce unnecessary pain and scarring from surgical biopsies, while improving the overall accuracy of diagnosis. As the authors note, the DermTech PLA is validated with proven clinical utility and a high sensitivity and low probability of missing melanoma.”

Surgical biopsies are the current standard method for testing suspicious lesions for melanoma, though they can cause discomfort and scarring for patients, and still carry a 17% chance of missing melanoma. Of the 4.5 million skin biopsies performed annually in the U.S. to rule out melanoma, approximately 180,000 cases of melanoma are detected. In addition, 8%-20% of pathologist-evaluated lesions are classified as ambiguous or indeterminate, demonstrating the difficulty and subjectivity in detecting melanoma based on a clinical visual assessment alone.

The DermTech PLA uses a revolutionary adhesive patch technology to collect skin cells from the surface of an entire lesion without a biopsy, leaving the lesion intact to offer dermatologists the option for additional analyses if necessary. The skin cells extracted from the patch are analyzed for genetic data associated with melanoma. The DermTech PLA is validated with proven clinical utility, and has a 91% sensitivity with less than a 1% chance of missing a melanoma (99% NPV).

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