DermTech, Inc. (DMTK) - Get Report ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today the launch of DermTech PLA plus TM, its next generation test for the enhanced early detection of melanoma. PLA plus delivers objective and actionable information to guide clinical management decisions for skin lesions suspicious of melanoma.
The new PLA plus test adds TERT (Telomerase Reverse Transcriptase) promoter DNA driver mutation analyses to the current RNA gene expression based Pigmented Lesion Assay (PLA), which includes LINC00518 and PRAME. TERT is individually associated with histopathologic features of aggressiveness and poor survival in melanoma. The combined tests (LINC00518 and PRAME, plus TERT) elevate the sensitivity from 91% 1 to 97% and maintain a negative predictive value of >99%, resulting in a less than 1% probability of missing melanoma 2,3. By combining RNA gene expression and DNA mutation analyses, PLA plus provides a highly accurate non-invasive genomic test for enhanced early melanoma detection.
"Identifying melanoma at its earliest stages provides patients with the highest cure rate, and TERT promoter mutations are independently associated with poor overall survival and more aggressive disease," said Laura Ferris, M.D., Ph.D., Associate Professor, Dermatology, University of Pittsburgh and senior author of Risk Stratification of Severely Dysplastic Nevi by Non-Invasively Obtained Gene Expression and Mutation Analyses. 2 "Having additional genomic information to objectively assess disease risk beyond what can be ascertained visually can help physicians make an earlier, more accurate diagnosis."
"DermTech is thrilled about the addition of DNA TERT promoter mutation analyses to our test menu for the enhanced early detection of melanoma," said Claudia Ibarra, chief operating officer at DermTech. "As always, it is our commitment to deliver high quality testing and laboratory services to our patients and clinicians, and PLA plus is a prime example of this."
The National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology recognize the use of pre-diagnostic non‑invasive genomic patch testing for melanoma, like the DermTech PLA TM, to help guide biopsy decisions for lesions suspicious of melanoma. There are over 21 peer reviewed publications summarizing its clinical validity and utility of the DermTech PLA TM in studies of over 7,000 patients.
- The lowest sensitivity of DermTech PLA demonstrated in our clinical studies to date
- Jackson SR et al. J of SKIN. 2020; 4(2):124-129
- Gerami P et al. J Am Acad Dermatol. 2017;76(1):114- 120.e2
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 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 Annual Report on Form 10-K 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.
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