LA JOLLA, Calif.–(BUSINESS WIRE)–DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today that Geisinger Health System (“Geisinger”) has issued a positive medical benefit policy for its Commercial and Medicare Business Segment for the DermTech Pigmented Lesion Assay (“PLA”).
DermTech’s PLA is the first non-invasive gene expression test for the early detection of melanoma. The PLA has a 99% negative predictive value (NPV), meaning there is a less than 1% probability of the PLA missing a melanoma when administered properly.
Per the policy, which closely mirrors the final local coverage determination by the Medicare Administrative Contractor, Palmetto GBA MolDx: Gene expression profiling for cutaneous melanoma utilizing the Pigmented Lesion Assay RNA gene expression test on skin samples obtained via adhesive patches is considered medically necessary when the following criteria are met:
- The lesion must meet one or more ABCDE criteria (Asymmetry, Border, Color, Diameter, Evolving)
- Primary melanocytic skin lesions is between 5mm and 19mm
- Lesion skin is intact (i.e., non-ulcerated or non-bleeding lesions)
- Lesion does not contain a scar or has been previously biopsied
- Lesion is not located in areas of psoriasis, eczema or similar skin conditions
- Lesion has not already been diagnosed as melanoma or for which the clinical suspicion is sufficiently high that the treating clinician believes melanoma is a more likely diagnosis than not
- Lesion is in areas other than palms of hands, soles of feet, nails, mucous membranes and hair covered areas that cannot be trimmed.
“We are thrilled that Geisinger Health System, an organization with a well-known commitment to quality healthcare delivery and innovation, reviewed the clinical dossier and peer-reviewed publication library for the PLA and issued a positive medical benefit policy. Using the PLA will enhance the early detection of melanoma sparing the patient the need for an invasive biopsy,” said Dan Visage, Senior Vice President of Payor Access for DermTech.
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 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.