DermTech, Inc. announced that it will discontinue the optional TERT promoter mutation add-on assay for its DermTech Melanoma Test (DMT) effective March 1, 2024. Multiple studies, including the Company's recently completed Trust 2 Study, demonstrated the DMT's negative predictive value (NPV) to be 99% or higher. A high NPV for a rule-out test provides assurance to clinicians and patients that a suspicious pigmented lesion which tests negative is unlikely to be a melanoma.

The TERT promoter mutation assay was offered as an optional add-on to the foundational gene expression assay for LINC00518 and PRAME based on initial validation data suggesting it conferred a modest increase in NPV. However, in the clinical setting, less than one-third of patient samples contain sufficient genomic material for TERT analysis. In the Trust 2 Study, the addition of TERT analysis decreased specificity slightly without providing a statistically significant increase in NPV.