DermTech, Inc. reported positive topline results from its Trust 2 Study, which evaluated the foundational gene expression assay component of the DermTech Melanoma Test (DMT) in a real-world clinical setting. The Trust 2 Study, initiated in 2021, enrolled over 20,000 patients tested with the DMT in a real-world clinical setting. Follow-up evaluations occurred for more than 5,000 tested lesions, with median and mean follow-up durations of 348 days and 337 days, respectively.

Follow-up evaluations included pathology diagnoses for lesions that were biopsied, and visual re-examination for lesions that were monitored rather than biopsied, in which the lesion was classified as either stable/unchanged or changed in a manner concerning for melanoma. The Trust 2 Study results demonstrated an NPV of 99.7% for the foundational gene expression assay component of the DMT. The NPV of 99.7% was observed (rather than calculated from an assumed prevalence), and was associated with a narrow 95% confidence interval of 99.5% to 99.9%.

The Trust 2 Study results also included a sensitivity of 95.8%, a specificity of 69.4% and a positive predictive value (PPV) of 13.4%. The Trust 2 Study results further validate the 99% NPV observed in a similar real-world study (Trust 1) published in 2021, which evaluated the tested lesions of more than 1,500 patients.