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 United States alone, melanoma diagnoses increased 53 percent 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 United States 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, M.D., CEO 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 percent sensitivity with less than a 1 percent chance of missing a melanoma (99 percent 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.
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.