TEST:

DermTech Melanoma Test

"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)."

No abstract available

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.

No abstract available

"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%."

No abstract available

"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."

"DermTech, Inc...announced a favorable coverage policy from Highmark Inc. (Highmark). Highmark and its Blue-branded affiliates provide health insurance to approximately 7 million members in Pennsylvania, West Virginia, Delaware and New York. 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."

"DermTech, Inc...announced that ECRI completed its evaluation of the Pigmented Lesion Assay (PLA), the foundational assay for the DermTech Melanoma Test (DMT), and changed its rating from ‘Inconclusive’ to ‘Somewhat Favorable’. ECRI is an independent, nonprofit organization focused on healthcare technology evaluation and safety to improve quality, reduce cost and achieve better outcomes across all healthcare settings."

"DermTech, Inc...announced an agreement with a Blues plan in Hawaii. The contract, which is in addition to a favorable coverage policy, enhances access to the foundational assay of the DermTech Melanoma Test (DMT) for the nearly 800,000 members of this plan."

"DermTech, Inc...announced that the DermTech Melanoma Test (DMT) has tested more than 200,000 suspicious pigmented lesions. The DMT uses non-invasive Smart Stickers™ to test for select genomic markers associated with melanoma, one of the deadliest forms of skin cancer. With a negative predictive value of over 99 percent, the test rules out melanoma with high probability."

"DermTech, Inc...announced agreements with a Blues plan in South Carolina and the United Mine Workers of America Health and Retirement Funds ('UMWA Funds'). The contracts, which are both effective April 1, 2023, enhance access to the foundational assay of the DermTech Melanoma Test ('DMT') for the approximately 1.7 million members of the Blues plan in South Carolina and the 90,000 beneficiaries of the UMWA Funds. The UMWA Funds is a group of multi-employer plans that provide health and pension benefits to retired coal miners and their eligible dependents. The DMT is an innovative, non-invasive way to enhance melanoma detection with a greater than 99 percent negative predictive value ('NPV')."

We found that asymmetry of color was a significant predictor for PRAME expression (Odds Ratio (OR) 5.5, 95% Confidence Interval (CI) 1.6-34.5, p = 0.004), blue color and negative pigment network were significant predictors for LINC00518 expression (adjusted OR 2.7, 95% CI 1.2-5.5, p = 0.014 and adjusted OR 5.4, 95% CI 1.6-16.9, p = 0.010, respectively), and atypical polymorphous vessels present in a pigmented skin lesion were a significant predictor for TERT promoter mutations (OR 5.8, 95% CI 1.3-23.4, p = 0.022). The results presented suggest a hierarchy in the significance of these dermoscopic features and may help guide evaluation and management of pigmented skin lesions.

"DermTech, Inc...announced an agreement with a Blues plan in North Carolina. The contract, which is in addition to a favorable coverage policy that became effective March 15, 2023, enhances access to the foundational assay of the DermTech Melanoma Test (DMT) for the more than 3.8 million members of this plan."

Overall quality of studies was low, and the reliability of sensitivity and specificity is questionable. However, TS may supplement well-established diagnostic methods as pooled analysis of five studies indicates a moderate sensitivity. Future studies are needed to obtain more reliable data as independent studies with no conflict of interest.

"DermTech, Inc...announced that it is participating in the 2023 American Academy of Dermatology (AAD) Annual Meeting, which will take place on March 17-21 in New Orleans...DermTech will present four new posters focused on topics including the efforts in development of a basal cell carcinoma diagnostic gene signature and evaluation of the DermTech Melanoma Test (DMT) in higher Fitzpatrick Skin Types."

New technologies for the diagnosis and prognosis of melanocytic lesions have been emerging to ensure earlier and more accurate detection. In this article, we review multiple technologies that improve melanoma diagnostic accuracy such as electrical impedance spectroscopy, pigmented lesion assay, reflectance confocal microscopy, and gene expression profile tests.

"DermTech, Inc...announced an agreement with a Blues plan in Arizona. The agreement makes the foundational assay of the DermTech Melanoma Test (DMT) available to the approximately 1.9 million members of this plan. The DMT is an innovative, non-invasive way to enhance melanoma detection with a greater than 99 percent negative predictive value (NPV)."

These results suggest the PLA performs as expected in FP IV-VI and that melanin content does not influence assay performance, or the ability of the test to generate a result. Self-collection of samples appears similar to clinician collected samples with respect to pre-test quality assessment.

"DermTech, Inc...announced that U.S. General Services Administration has recommended the Company’s foundational assay included in the DermTech Melanoma Test (DMT) for coverage by the Veterans Health Administration (VHA)."

"DermTech, Inc...announced favorable coverage policies from two commercial payers comprising a Blues plan in Hawaii and a physician-founded, member-focused and community-based not-for-profit health plan in New York. The coverage policies resulted from an independent technology assessment by the second largest laboratory benefits manager in the U.S. and are similar to the Medicare coverage policy of the Company’s foundational assay included in the DermTech Melanoma Test (DMT)."

"DermTech, Inc...announced that the Defense Health Agency’s Lab Joint Working Group has recommended the Company’s foundational assay included in the DermTech Melanoma Test (DMT) for coverage by TRICARE. TRICARE is the health care program for uniformed service members, retirees and their families around the world."

"DermTech, Inc...announced favorable coverage policies from four commercial payers including Blue Cross Blue Shield of North Carolina (BCBS NC), Blue Cross Blue Shield of South Carolina (BCBS SC), Blue Cross Blue Shield of Louisiana (BCBS LA) and Blue Cross Blue Shield of Kansas City (BCBS KC). These coverage policies were announced pursuant to an independent technology assessment by the second largest laboratory benefits manager in the U.S. and are similar to the policy issued by Medicare for coverage of the Company’s foundational assay for the DermTech Melanoma Test (DMT)."

Conclusion The high proportion of non-actionable results and discrepant cases highlights potential barriers to the widespread adoption of PLA testing. The high proportion of genetic analysis failure seen for TERT and limited influence on the proposed risk suggests TERT does not offer significant clinical value.

"DermTech, Inc...announced...an agreement with Sonora Quest Laboratories (Sonora Quest)...to expand access to enhanced melanoma detection. As a result of the agreement, Sonora Quest will be the exclusive laboratory in Arizona to offer the DermTech Melanoma Test to its vast network of healthcare providers...The DermTech Melanoma Test uses a non-invasive Smart Sticker™ to lift skin cells from the surface of a patient’s skin to be tested for select genomic markers associated with melanoma."

"DermTech, Inc...announced today that SKIN: The Journal of Cutaneous Medicine has published its original research study...By incorporating the Pigmented Lesion Assay ('PLA') into the current care pathway of assessing pigmented skin lesions or moles suspicious for melanoma, the study highlights the potential reduction in cost for commercial health insurance plans, in addition to a higher quality of care for patients and improved health outcomes."

Tape stripping is unique and advantageous in its ability to provide a non-surgical approach to evaluating the human epidermis. The cellular and molecular components of the skin are used to diagnose different skin conditions without invasive skin biopsy.

RS showed high accuracy for the diagnosis of skin cancer, although more clinical studies are required. Advances in these technologies for the diagnosis of skin cancer can lead to the realization of optimized and individualized treatments.

Study findings are limited by the small case volume. Dermatologists should recognize the potential limitations of PLA use in the evaluation of equivocal lesions for melanoma, including risk for false-positive results, which may require unnecessary biopsies for patients and the costs associated with indeterminate test results.

We estimated that publicly funding pigmented lesion assay in Ontario over the next 5 years would result in additional costs of $3.44 million (if used exclusively by primary care providers) or $2.56 million (if used exclusively by specialists). For people who had experienced biopsy for suspected melanoma, it was felt that pigmented lesion assay could represent an effective tool to increase early detection and avoid unnecessary biopsies, if the tool was accurate.

"All 34 lesions (100%) were surgically biopsied, with 3 (1%) diagnosed as Stage 0 (in situ ), identified 13, 14 and 19 months after the initial PLA (NPV = 99.0% [CI95% = 97.1 - 99.8]). This long-term repeat-testing study confirmed the NPV of the PLA and found no adverse outcomes related to the test’s routine use."