LA JOLLA, Calif.–(BUSINESS WIRE)–DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, today announced that SKIN, the official journal of the National Society for Cutaneous Medicine, published proof-of-concept data demonstrating that patients are able to reliably perform remote self-sampling of concerning moles using the DermTech Pigmented Lesion Assay (the “DermTech PLA”) under physician supervision via telemedicine, enabling actionable molecular testing for accurate melanoma detection.
As part of the Institutional Review Board (IRB) approved pilot study, 258 eligible melanoma survivors were contacted, and of the 211 who expressed interest in the DermTech PLA, there were seven cases of self-identified concerning lesions, which were confirmed by a clinician to be suspicious of melanoma. These patients then conducted sample collections using DermTech’s non-invasive adhesive skin collection kit at home under the supervision of a clinician via telemedicine.
Results from the study showed that skin samples collected by patients enabled successful PLA testing to objectively rule out melanoma in all (100%) of the cases evaluated. These findings are in line with sample collection results by licensed providers.
In addition, survey findings indicated that anxiety around skin self-examination increased during COVID-19 due to the lack of, or limited, physician access. Responses also uncovered a desire among high-risk patients for accurate melanoma detection options for circumstances such as this.
“It is critical to catch and treat melanoma early for the best chance of survival,” said the lead author of the study, Dr. June K. Robinson, a dermatologist who is a Research Professor of Dermatology at the Northwestern University Feinberg School of Medicine. “This non-invasive remote sample collection option has the potential to bring greater peace of mind to patients, especially those who are at high-risk for melanoma. During a time when physician visits are limited, this at-home mole sample collection option is a benefit to the patient, who is likely anxious or concerned about a suspicious mole. The DermTech PLA allows me to offer quick and accurate results with this easy-to-use, trusted and validated test, which helps to determine if an office visit is necessary to surgically biopsy a mole that looks suspicious clinically. In over 90% of cases, the PLA helps to avoid an unnecessary surgical biopsy.”
“These findings come at a critical time, demonstrating the clinical utility of this remote sample collection approach during the COVID-19 pandemic. The DermTech PLA provides an effective and reliable solution to empower patients and physicians to remain vigilant and attentive to suspicious lesions, especially when physician access is limited,” said Burkhard Jansen, MD, Chief Medical Officer of DermTech. “Even as we move beyond the current shelter in place restrictions, non-invasive remote collection by the patient with the DermTech PLA, under the guidance of a clinician, has potential to expand patient access to important and objective testing for this deadly disease. Skin cancer doesn’t wait, and now patients don’t have to either.”
The DermTech PLA uses a revolutionary adhesive patch technology to collect skin cells from the surface of an entire lesion without a surgical biopsy, leaving the lesion intact to offer dermatologists the option for further analyses if necessary. The skin cells extracted from the patch are analyzed for gene expression 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). 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.
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 an order for the DermTech PLA. Once requested by the clinician, the DermTech PLA Adhesive Skin Collection Kit is shipped directly to the patient with support from DermTech customer service. During a follow-up teledermatology appointment, the clinician will instruct and supervise the patient to collect their sample with the easy-to-use DermTech PLA adhesive collection kit. The patient will then return the collected sample(s) back to DermTech 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.