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Pigmented lesion assay prevents unnecessary biopsies in skin lesions
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Twelve-month data from a large U.S. registry study confirmed the clinical utility and high negative predicative value of a pigmented lesion assay as a diagnostic tool in melanoma, according to research in Dermatology Online Journal.
“The clinical impact of the [pigmented lesion assay] is enhanced early melanoma detection leading to fewer unnecessary biopsies,” Laura K. Ferris, MD, PhD, associate professor in the department of dermatology at University of Pittsburgh, told Healio Dermatology. “This means fewer scars, fewer biopsy sites at risk of infection, fewer specimens sent to pathology paired with improved care at lower cost.”
Ferris and colleagues enrolled 734 pigmented lesion assay negative, or PLA(-), skin lesions clinically suspicious for melanoma from five dermatology practices in the U.S. Each center used the PLA test (DermTech) for more than 12 months. Charts were reviewed for lesion characteristics and current lesion disposition, according to the study.
The test uses adhesive patches that are applied over a lesion on the skin that is concerning for melanoma and noninvasively collects a sample from that lesion, Ferris said in an interview.
“When the patch is removed it brings with it some cells from the underlying pigmented skin lesion,” Ferris said. “From these cells, DNA and RNA can be isolated and evaluated for the expression (RNA) of two genes, LINC and PRAME, and for the presence of mutations in the (DNA) in genes known to drive melanoma progression including BRAF, NRAS and the TERT promoter.”
The presence of these genes and mutations suggests a higher probability that melanoma is present, and the clinician can use the information to decide whether to biopsy, Ferris said.
“The absence of these mutations and LINC and PRAME expression has over a 99% negative predictive value, meaning that it is very unlikely that the lesion without these molecular risk factors is melanoma,” Ferris added.
Monitoring without surgical biopsy occurred in 721 (98.2%) of lesions and 13 (1.8%) lesions were subjected to biopsies within the 12-month follow-up, the researchers wrote.
In the biopsied lesions, 11 were nevi with various degrees of cellular atypia, one was a basal cell carcinoma and one was a squamous cell carcinoma, according to the study.
Additionally, they initiated a registry study from 40 dermatology practices in the U.S., of which 1,575 pigmented lesions were evaluated by PLA.
In total, 1,433 PLA(-) cases were reported and 1,431 (99.9%) of these cases were managed with a lesion monitoring that prevented surgical procedures, according to the study. Of those, 132 (9.2%) cases were scheduled for follow-up in 3 months, 383 (26.7%) in 6 months of follow-up and 732 (51%) in 12 months.
From the 142 PLA(+) test results, 96.5% were surgically biopsied. Detected levels of LINC and PRAME transcripts were identified in 21 (21.8%) of all assessed PLA(+) cases, 85 (59.9%) tests showed detectable levels of the LINC transcript only and 26 (18.3%) had detectable levels of the PRAME transcript only, according to the study.
The PLA tool identifies melanoma at the earliest stages and facilitates monitoring lesions that do not need biopsy, according to the study.
The test is widely available to clinicians, is covered by some insurance plans and has a maximum patient out-of-pocket cost of $50 per test for those commercially insured, Ferris said.
The next steps involve providing both RNA and DNA information on every test, Ferris added.
“The noninvasive sample collection platform and the approach used also lends itself to applications in nonmelanoma skin cancers and in inflammatory skin conditions,” Ferris said. – by Abigail Sutton
Disclosures: The study was partially supported by DermTech. Ferris is a member of the DermTech scientific advisory board.