DermTech Announces Positive Topline Results From Trust 2 Study Evaluating the DermTech Melanoma Test (DMT)
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Insights
The Trust 2 Study's reported high negative predictive value (NPV) of 99.7% for the DermTech Melanoma Test (DMT) is a significant finding within the field of precision dermatology. NPV is a statistical measure that indicates the likelihood of a test correctly identifying the absence of a condition—in this case, melanoma. A high NPV is particularly valuable in medical diagnostics as it minimizes the risk of false negatives, which can be critical in the early detection and treatment of cancer. The study's large sample size and real-world setting enhance the credibility of these findings, potentially leading to increased adoption of the DMT in clinical settings.
From a healthcare economics perspective, the potential reduction in unnecessary biopsies and associated procedures could translate into cost savings for the healthcare system. This is especially relevant as payers scrutinize the cost-effectiveness of new technologies. The DMT's high NPV and non-invasive nature could therefore be a compelling value proposition for insurance companies considering reimbursement, which would, in turn, affect the market adoption of this technology.
However, the specificity of 69.4% suggests that while the test is excellent at ruling out melanoma when negative, there is still a considerable number of false positives, which could lead to patient anxiety and additional follow-ups. The balance between NPV, sensitivity, specificity and positive predictive value (PPV) must be carefully considered by clinicians when integrating the DMT into their practice.
The positive results from the Trust 2 Study could have a meaningful impact on DermTech's market position. As precision medicine becomes more prevalent, tests like the DMT that offer high accuracy and non-invasive diagnostics could see increased demand. The DMT's ability to rule out melanoma with high confidence may differentiate it from other diagnostic methods, potentially leading to greater market share within the dermatological diagnostic space.
Moreover, the emphasis on real-world clinical utility is likely to resonate with practitioners and could drive up the rate of clinical adoption. This is particularly pertinent as discussions with payers regarding reimbursement are ongoing. Reimbursement approval could significantly lower barriers to entry for patients and providers, potentially leading to increased sales and revenue for DermTech.
Investors will likely monitor the company's progress in securing reimbursement, as well as any changes in competitive dynamics, regulatory environment and the broader adoption of genomic-based diagnostics. These factors will be critical in assessing the long-term commercial success of the DMT and DermTech's financial performance.
The Trust 2 Study's findings are encouraging for the field of oncology, particularly in melanoma management. Melanoma is a serious form of skin cancer that requires early detection for optimal treatment outcomes. The reported sensitivity of 95.8% indicates that the DMT is highly effective in correctly identifying melanoma when present, which is crucial for patient prognosis.
While the DMT's high NPV can reduce the number of unnecessary invasive procedures, it is essential to consider the patient management pathway post-test. A false positive result, indicated by a lower PPV, must be managed carefully to avoid overtreatment and patient distress. Clinicians will need to weigh the benefits of reduced biopsies against the potential for increased surveillance in patients with false positive results.
Furthermore, the integration of the DMT into standard clinical protocols would require education and training for healthcare providers to ensure appropriate interpretation and follow-up. The non-invasive nature of the test is a significant advantage for patient comfort and acceptance, potentially leading to earlier presentation and diagnosis of suspicious lesions.
- Trust 2 Study demonstrated powerful clinical utility for the DMT as a rule-out test for melanoma
- Negative predictive value (NPV) higher than
“The Trust 2 Study results reaffirm the DMT’s real-world clinical utility to rule out melanoma with a negative predictive value (NPV) that is higher than other currently available methods,” said Loren Clarke, M.D., chief medical officer, DermTech. “Importantly, for clinicians and patients, a high NPV delivers assurance that a suspicious pigmented lesion which tests negative is unlikely to be a melanoma. As a non-invasive test that has demonstrated an NPV of
Dr. Clarke continued, “The DMT may also help clinicians avoid biopsies and other procedures for benign lesions and thereby reduce healthcare costs. Finally, we believe these positive results will support re-engagement with payers as they consider reimbursement for the DMT.”
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
“The Trust 2 Study illustrates that a high NPV test such as the DMT can allow physicians to confidently rule out melanoma for their patients,” commented Maral K. Skelsey, M.D., Clinical Professor of Dermatology at Georgetown University’s Medical School and one of the lead Trust 2 Study investigators. “Our clinic at the Dermatologic Surgery Center of
About The DermTech Melanoma Test
DermTech originally marketed its foundational assay under the name Pigmented Lesion Assay (PLA). The PLA assesses pigmented skin lesions, moles or dark skin spots for melanoma. In particular, the PLA detects expression of the LINC00518 (LINC) and preferentially expressed antigen in melanoma (PRAME) genes using reverse transcription-polymerase chain reaction (RT-PCR). The Company introduced an add-on assay to the PLA in 2021, which is designed to identify the presence of mutations in TERT gene promoter region using DNA sequencing. The Company has since branded its PLA and TERT add-on-assay as the DermTech Melanoma Test (DMT). The DMT may be ordered with or without the add-on test for TERT. Positive results for LINC, PRAME or TERT correlate with a lesion at higher risk for melanoma. If none of the biomarkers are detected, this result indicates a
About DermTech
DermTech is a leading genomics company in dermatology and is creating a new category of medicine, precision dermatology, enabled by its non-invasive skin genomics technology. DermTech’s mission is to improve the lives of millions by providing non-invasive precision dermatology solutions that enable individualized care. DermTech provides genomic analysis of skin samples collected using its Smart Stickers™. DermTech develops and markets products that facilitate the assessment of melanoma. For additional information, please visit DermTech.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of DermTech may differ from its actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “runway,” "outlook," “anticipate,” “intend,” “plan,” “strive," “may,” “will,” “sustain,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations and evaluations with respect to: the performance, patient benefits, cost- effectiveness, commercialization and adoption of DermTech’s products and the market opportunity for these products; and expectations regarding agreements with or reimbursement by or cash collection patterns from government payers (including Medicare) and commercial payers and related billing practices or number of covered lives. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results including risks and uncertainties included in the “Risk Factors” section of the most recent Annual Report on Form 10-K filed by DermTech with the Securities and Exchange Commission (the “SEC”), and other documents filed or to be filed by DermTech with the SEC, including subsequently filed reports. DermTech cautions that the foregoing list of factors is not exclusive. You should not place undue reliance upon any forward- looking statements, which speak only as of the date made. DermTech does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
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Steve Kunszabo
DermTech
(858) 291-1647
steve.kunszabo@dermtech.com
Source: DermTech, Inc.
FAQ
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