Study demonstrated the DMT’s effectiveness as a melanoma rule-out test for all skin types
The PLA assesses pigmented skin lesions, moles or dark skin spots for melanoma. (Credit: Amplitude Magazin on Unsplash)
DermTech, a leader in precision dermatology enabled by a non-invasive skin genomics technology, today reported positive topline results from a study evaluating the foundational gene expression assay component of the DermTech Melanoma Test (DMT) across all skin types in the real-world clinical setting. The peer-reviewed study entitled, “Non-invasive gene expression analysis rules out melanoma with high negative predictive value regardless of skin phototype” was presented at the Winter Clinical Dermatology Conference (January 12-17, 2024).
Using follow-up information and biopsy results from a large registry database that also served as the basis for the Company’s recently completed Trust 2 Study, this study compared the DMT’s performance in patients with Fitzpatrick skin phototypes I-III (n=4,152) to its performance in patients with skin phototypes IV-VI (n=130). As in prior DMT studies, lesions on acral skin (palms, soles and nailbeds) were excluded because the thicker skin on acral sites may interfere with the test’s non-invasive sample collection method.
The negative predictive value (NPV) for both groups (I-III and IV-VI) was greater than 99%, and the 95% confidence interval for the difference in NPV between the groups indicated that there was no significant difference between the skin phototype groups. Additional analysis limited to subjects with re-examination of DMT-negative lesions at least 6 months after testing confirmed the results observed in the full cohort. These data establish that the DMT’s performance does not vary across Fitzpatrick skin types.
“This study demonstrated that regardless of a patient’s skin type, the DMT can help clinicians rule out melanoma non-invasively, with an NPV of over 99%,” said Loren Clarke, M.D., chief medical officer, DermTech. “A high NPV means a suspicious pigmented lesion that tests negative is unlikely to be a melanoma. The DMT provides genomic information that can help guide biopsy decisions for suspicious pigmented lesions across all skin types.”
“This study shows that the DMT can help clinicians improve outcomes for cutaneous melanomas in patients of all skin types,” commented Neal Bhatia, M.D., director of Therapeutics Clinical Research and a co-author of the study. “This is significant progress toward making this test available for patients with Fitzpatrick skin types IV-VI, which is important because ruling out melanoma in individuals with these skin types can be particularly challenging.”
Source: Company Press Release