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DermTech Melanoma Test

Laboratory Developed Test
DermTech originally marketed its foundational assay under the name Pigmented Lesion Assay (PLA). The PLA assessed pigmented skin lesions, moles or dark skin spots for melanoma. In particular, the PLA detected expression of the LINC00518 (“LINC”) and preferentially expressed antigen in melanoma (“PRAME”) genes using an amplification process called reverse transcription-polymerase chain reaction (“RT-PCR”). The Company introduced its second-generation PLA test, PLAplus, in 2021, which could also identify the presence of TERT using a DNA sequencing technique and adding the TERT promoter mutation analyses to the PLA gene expression test. The DMT tests for LINC and PRAME, and may be ordered with or without the add-on test for TERT. Positive results for LINC, PRAME, or TERT correlate with the presence of melanoma. If the biomarkers are not detected, this result indicates a greater than 99% probability that the mole being tested is not melanoma.
LINC00518 (Long Intergenic Non-Protein Coding RNA 518), PRAME (Preferentially Expressed Antigen In Melanoma)