TEST:

DermTech Melanoma Test

The overall positive predictive value for surgically actionable melanocytic lesions was 24.0%. The positive predictive values of the individual genes were determined to be 28.2% for LINC00518, 34.7% for PReferentially expressed Antigen in Melanoma, and 31.8% for telomerase reverse transcriptase.

"DermTech, LLC...announced the publication of an important study in the Journal of the American Academy of Dermatology (JAAD) entitled 'Clinical Performance of a Noninvasive Melanoma Rule-Out Test Across Fitzpatrick Skin Types.'...This study assessed the DermTech Melanoma Test (DMT) across all skin types in a real-world clinical setting (73 sites) and compared the test'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)."

In our experience this ABPLA has a sensitivity of 92.0%, a specificity of 79.5%, a positive predictive value of 16.9%, and a negative predictive value of 99.5% for the detection of melanoma.

"DermTech, Inc...announced the presentation of two research abstracts at the 2024 American Academy of Dermatology (AAD) Annual Meeting, taking place March 8th-12th in San Diego, California...The first research abstract, 'Non-invasive gene expression analyses to rule out melanoma in patients with Fitzpatrick skin types IV-VI” will be presented'..."

"DermTech, Inc...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...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)....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."

"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."

"DermTech, Inc...today 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....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%."

"DermTech, Inc...announced agreements with Highmark Inc. (Highmark). The contracts, which are in addition to a favorable coverage policy, enhance access to the foundational assay of the DermTech Melanoma Test (DMT)."

"DermTech, Inc...announced a favorable coverage policy with a Blues plan in Michigan. The favorable coverage policy, which is in addition to a contract that became effective in August 2022, enhances access to the foundational assay of the DermTech Melanoma Test (DMT) for the approximately 4.5 million members of this plan. The Pigmented Lesion Assay (PLA), the foundational assay of the DMT, is an innovative, non-invasive way to rule out melanoma with a 99 percent negative predictive value (NPV)....DermTech’s total covered lives in the U.S. are approximately 133 million, which includes 68 million for Medicare/Medicare Advantage and 65 million for commercial and governmental payers."