DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today that SKIN: The Journal Of Cutaneous Medicine has published research including the results of DermTech’s TRUST study. The large research study supports that evaluation of genomic atypia with DermTech’s Pigmented Lesion Assay (“PLA” or the “DermTech Melanoma Test”) increases both the real-world negative predictive value (NPV) and positive predictive value (PPV) of the melanoma diagnostic pathway and reduces biopsy burden, relative to the current visual assessment and histopathology pathway.
The publication, “Non-Invasive Detection of Genomic Atypia Increases Real-World NPV and PPV of the Melanoma Diagnostic Pathway and Reduces Biopsy Burden,” reports that the non-invasive detection of genomic atypia by the PLA can complement visual assessment of pigmented lesions and enhance the early detection of melanoma, enabling clinicians to triage suspicious lesions more effectively to determine which lesions are high risk and should be biopsied versus safely managing benign lesions via clinical surveillance.
The TRUST study was conducted in the U.S. by examining a cohort of 2,575 PLA-tested lesions for evidence of melanoma detected during a protracted follow-up period of up to 36 months and by re-testing a subset of 302 PLA-negative lesions up to 24 months after the initial PLA test. These results demonstrate that in this real-world intended use population, the PLA has an NPV of greater than 99%, confirming the high NPV established in previous clinical studies.
Real-world PPV of 18.7% was determined by identifying melanoma diagnoses among PLA-positive lesions within a US-based registry of 3,418 PLA-tested cases. The PLA’s detection of genomic atypia enriched the pool of biopsied lesions nearly five-fold for those most likely to be diagnosed as high-risk or severely atypical and malignant.
Of the 5,993 lesions tested with the PLA (TRUST Study and registry cases), the vast majority of PLA tests were negative and not subjected to surgical biopsy.
The published findings in SKIN can be found here: https://jofskin.org/index.php/skin/article/view/1327
“Many tests require a compromise with respect to NPV and PPV in which optimizing one comes at the expense of the other. Maximum NPV is priority for a test designed to safely rule out melanoma, yet this study confirms that the PLA’s high NPV is balanced by a PPV that offers a significant improvement over the current care pathway,” commented Dr. Maral Kibrian Skelsey, lead author and Clinical Associate Professor of Dermatology at Georgetown University.
“The TRUST Study illustrates that the PLA can detect melanoma at the earliest stages when it is curable. This long-term follow-up data of PLA-negative tests also provides clinicians confidence in use of this precision genomic technology to effectively rule out lesions not harboring melanoma,” commented Dr. Gary Peck, co-author and melanoma expert at the Dermatologic Surgery Center of Washington.
DermTech is the leading genomics company in dermatology and is creating a new category of medicine, precision dermatology, enabled by our non-invasive skin genomics platform. DermTech’s mission is to transform dermatology with our non-invasive skin genomics platform, to democratize access to high quality dermatology care, and to improve the lives of millions. DermTech provides genomic analysis of skin samples collected non-invasively using an adhesive patch rather than a scalpel. DermTech markets and develops products that facilitate the early detection of skin cancers, and is developing products that assess inflammatory diseases and customize drug treatments. For additional information on DermTech, please visit DermTech’s investor relations site at: www.DermTech.com.
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,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations with respect to: the performance, patient benefits, cost-effectiveness, commercialization and adoption of DermTech’s products, including the DermTech Melanoma Test and Smart Sticker platform, and the market opportunity therefor. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of DermTech and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against DermTech; (2) DermTech’s ability to obtain additional funding to develop and market its products; (3) the existence of favorable or unfavorable clinical guidelines for DermTech’s tests; (4) the reimbursement of DermTech’s tests by Medicare and private payors; (5) the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for DermTech’s products; (6) DermTech’s ability to grow, manage growth and retain its key employees; (7) changes in applicable laws or regulations; (8) the market adoption and demand for DermTech’s products and services together with the possibility that DermTech may be adversely affected by other economic, business, and/or competitive factors; and (9) other risks and uncertainties included in (x) the “Risk Factors” section of the most recent Quarterly Report on Form 10-Q filed by DermTech with the Securities and Exchange Commission (the “SEC”), and (y) other documents filed or to be filed by DermTech with the SEC. 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.