LA JOLLA, CALIF.--(BUSINESS WIRE)--
DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), today announced that its lead non-invasive melanoma detection test, the DermTech Pigmented Lesion Assay (the “DermTech PLA”), is now available for use by clinicians and their patients via telemedicine. DermTech is the leader in precision dermatology with its adhesive patch test technology providing objective genomics data to help guide clinical decisions. This first-of-its-kind genomic diagnostic test enables patients, under the order of a physician, to non-invasively sample a lesion suspicious for melanoma at home via a supervised telemedicine appointment. DermTech’s teledermatology offering comes at a critical time for patients and physicians because it eliminates the need for unnecessary office visits during the COVID-19 pandemic.
Melanoma is the most deadly and aggressive form of skin cancer, and early detection is critical to provide patients with their best chance for a cure. It is the fastest growing cancer worldwide, and in the U.S. alone, melanoma diagnoses increased 53% from 2008 to 2018. For decades, biopsies have been the standard method for testing suspicious moles for melanoma, but using a scalpel to remove a portion of the mole is not always necessary and can be painful and leave scarring behind. Of the 4.5 million skin biopsies performed annually in the U.S. to rule out melanoma, approximately 180,000 cases of melanoma are detected, demonstrating the difficulty and subjectivity in detecting melanoma based on visual assessment alone.
“While the majority of skin cancers can be relatively slow growing, melanoma is an exception to this rule and any delay in diagnosis, by even a month or two, can be the difference between life and death,” said Dr. June K. Robinson, a dermatologist who is a Research Professor of Dermatology, Northwestern University Feinberg School of Medicine. “The DermTech PLA is an important tool to non-invasively rule in or out melanoma in suspicious pigmented lesions with excellent accuracy. Today, in the current COVID-19 climate, the DermTech PLA is an essential tool that assists the doctor providing teledermatology care. If I identify a lesion on my patient that is concerning, the DermTech PLA Adhesive Skin Collection Kit allows me to offer this assay as a way of acquiring useful and accurate information to guide clinical decision making and determine if an office visit is necessary to remove the lesion.”
“Melanoma won’t wait – this has been our rallying cry throughout this global pandemic, and it’s the reason we made the swift decision to close our offices early on and keep our genomics lab operational so we could pivot our melanoma testing to be available via telemedicine, a solution we always planned on promoting, but which healthcare providers now need immediately in these circumstances,” said John Dobak, MD, Chief Executive Officer of DermTech. “DermTech is committed to transforming the practice of dermatology through our revolutionary non-invasive adhesive patch, which provides greater accuracy and earlier detection of melanoma. The remote use of our DermTech PLA Adhesive Skin Collection Kit enabled through teledermatology reinforces our commitment to empowering dermatologists to safely serve patients during this unprecedented time and further establishes what we believe will be a valuable new offering for years to come.”
The DermTech PLA uses a revolutionary adhesive patch technology to collect skin cells from the surface of an entire lesion without a biopsy, leaving the lesion intact to offer dermatologists the option for additional analyses if necessary. The skin cells extracted from the patch are analyzed for genetic data associated with melanoma. The DermTech PLA is highly validated with proven clinical utility, and has a 91% sensitivity with less than a 1% chance of missing a melanoma (99% NPV) in studies conducted in a clinical office setting. DermTech is collecting data to verify that these clinical study results are replicable for patient-collected samples. Since its launch in 2016, the DermTech PLA has been used to assess more than 50,000 lesions and remains the first and only non-invasive gene expression test in dermatology.
For more information about the DermTech PLA Adhesive Skin Collection Kit:
About Use of DermTech PLA Adhesive Skin Collection Kit Via Teledermatology:
A clinician can assess the patient’s skin and suspicious lesion(s) via a teledermatology appointment and, if indicated, submit a patient-specific order to DermTech for the DermTech PLA. If requested by the clinician, the DermTech PLA Adhesive Skin Collection Kit will then be shipped directly to the patient with support from DermTech customer service. During a follow-up teledermatology appointment, a clinician will instruct and supervise the patient to collect their sample with the easy-to-use DermTech PLA adhesive patch. The patient will then return the collected sample(s) back to DermTech via the pre-labeled FedEx or UPS envelope for analysis. Assay results will be available to the ordering clinician within a few days. A clinician can assess the patient’s skin and suspicious lesion(s) via teledermatology where permitted by state law. Clinicians should confirm applicable laws and third party payor reimbursement rules governing telemedicine visits.
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 the practice of dermatology through more accurate diagnosis and treatment, and the elimination of unnecessary surgery, leading to improved patient care and lower costs. 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.
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,” “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 effects of the COVID-19 pandemic and the effectiveness of DermTech’s response thereto; changes in patient behavior and market conditions; patient and physician adoption of telemedicine and the effectiveness of the DermTech PLA administered via telemedicine; and the performance, patient benefits, cost-effectiveness and commercialization 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 with the Securities and Exchange Commission (the “SEC”) by the company, and (y) other documents filed or to be filed with the SEC by the company. 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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