On March 5, 2020 DermTech, Inc. (NASDAQ:DMTK) ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported that the Journal of Drugs and Dermatology has published the results of a large registry study confirming the clinical utility of the DermTech Pigmented Lesion Assay (the "DermTech PLA") (Press release, DermTech International, MAR 5, 2020, View Source [SID1234555238]). The study also confirmed the value of DermTech’s adhesive patch by demonstrating that community-based clinicians using the DermTech PLA were able to reduce unnecessary biopsies by up to 90%, lower healthcare costs and rule out melanoma via a genomics approach that elevates pigmented lesion management beyond what the eye can see.

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"The DermTech PLA helps clinicians employ precision dermatology and harness genomics technology to detect malignant changes that are otherwise unable to be identified visually or with histopathology, reducing the probability of missing melanoma to <1%," said Ronald Moy, M.D., member of the DermTech Scientific Advisory Board and former president of the American Academy of Dermatology. "DermTech’s PLA test has the potential to elevate patient care by bringing precision genomics detection to a field that has been relying on highly subjective measures to inform biopsy decisions."

This large, yearlong utility study, conducted in the United States, included 90 providers across 53 dermatology offices and assessed 3,418 pigmented lesions clinically suspicious for melanoma with the DermTech PLA. The results of the study demonstrate that:

Clinicians use the DermTech PLA test results to guide how they practice medicine (97.53% of PLA positive lesions are surgically biopsied and 99.94% of PLA negative lesions are followed clinically and not biopsied).
90.52% (n = 3, 094) of DermTech PLA registry study test results were negative for melanoma and 9.49% (n = 324) were positive.
There is no difference in how board certified dermatologists and other licensed clinicians follow DermTech PLA results to guide biopsy decisions—potentially expanding access to care for underserved populations who often delay treatment for a disease in which early detection is critical.
The DermTech PLA identifies the gene expression associated with early melanoma by catching malignant changes a pathologist cannot see and reduces the risk of missing melanoma from 17% to less than 1%.
"Having used the DermTech PLA more than 600 times, I have seen it bring relief to people who were facing hundreds of biopsies, people concerned with facial scars and people who have experienced painful wound healing," said Brook Brouha, M.D., Ph.D., lead author on the study. "Using the PLA as a pain-free option allows providers to detect cancer before it spreads."

Up to 90% of all biopsies for suspected skin cancer are performed unnecessarily because the current standard to assess pigmented lesions remains ambiguous. These avoidable surgeries often result in multiple scars and research has shown that about 27% of older people biopsied experience poor wound healing, bleeding, or infection.

The study, "Real-world Utility of a Non-invasive Gene Expression Test to Rule out Primary Cutaneous Melanoma – A Large US Registry," is the 15th peer-reviewed publication validating the benefits of the DermTech PLA.

"This is our largest utility study to-date and these data further support the high utility of DermTech’s PLA and the high negative predictive value of this precision dermatology technology," said John Dobak, MD, Chief Executive Officer of DermTech. "The DermTech PLA can detect malignant changes in gene expression at earlier stages which can help avoid unnecessary biopsies and reduce costs."

DermTech’s PLA, which is covered by Medicare, uses RT-PCR (reverse transcriptase–polymerase chain reaction) to measure the gene expression of two genes, LINC00518 (long-intergenic non-coding RNA 00518) and PRAME (preferentially expressed antigen in melanoma) to identify the malignant changes of melanoma on the genomic level. A DermTech PLA test is positive if LINC, PRAME, or both target genes are detected as these molecular pathology findings are known to correspond with histopathology findings of in situ or invasive primary melanoma in 7%, 50% and 93% of cases, respectively.