DermTech
DMTK]

Although melanoma accounts for less than five percent of all skin cancer cases, it is responsible for the vast majority of skin cancer deaths. This form of cancer starts in the melanocytes—cells deep in the epidermis—or moles on the skin’s surface that produce pigment. Early detection and treatment is critical to prevent melanoma from spreading throughout the body. When melanoma is caught early, the survival rate is 99 percent. However, when a diagnosis is delayed, melanoma can spread internally in as little as three to six months, at which point the survival rate lowers to 80 percent or worse.

For several years, dermatologists have been struggling with the accurate detection of the disease. The reason? Traditional methods to detect melanoma essentially follow an algorithmic approach of visual inspection and subsequent biopsy. Doctors initially inspect the skin with their naked eye to determine its condition and decide on the best treatment. This is followed by an invasive biopsy and a histopathologic evaluation, which involves surgically removing the affected tissue and examining it under a microscope. The drawback of this process is that it typically reveals the presence of melanoma only 3.5 to 5 percent of the time. The subjectivity of the procedures leads to inaccuracy in the diagnosis and treatment of the disease.

DermTech [NASDAQ: DMTK], a San Diego, CA-based firm, is now changing the status quo of melanoma detection with its non-invasive genomic testing. “Our groundbreaking innovation enables dermatologists to look past the skin’s cells and deep within the skin’s genes to find and detect disease earlier and more accurately,” says John Dobak, M.D., president and CEO, DermTech.

Bringing Precision Dermatology to the Table

At the core of DermTech is an innovative non-invasive skin genomics platform—The DermTech Melanoma Test, which is enabled by a Smart Sticker™ that non-invasively assesses genomic and proteomic changes in the skin before they can be visually detected. In other words, it identifies altered cancerous cells long before they show up under a microscope through a proprietary gene expression test.

In essence, the Smart Sticker is an adhesive patch that can be used to painlessly collect skin cells from a suspicious skin spot—without the need for a scalpel. It empowers doctors to diagnose skin cancer—without cutting or scarring. “The process is painless, feels more like removing a scotch tape from the surface of the skin. It reduces unnecessary surgical procedures by ten-fold and the probability that there will be a missed melanoma,” adds Dobak.

Another notable aspect of the DermTech Melanoma Test is that patients can use the Smart Sticker to collect a skin sample from the comfort of their homes. All a dermatologist has to do is order the DermTech Melanoma Test through a telehealth visit and guide patients through the easy process of collecting their samples.

We are a genomics company, we deal with DNA but it is in our DNA that we always persevere. Our motto is: try, fail, pivot and learn

The sample is then submitted to the DermTech Gene Lab to analyze genomic changes (RNA and DNA) that correlate with melanoma. If changes in the genes are found, dermatologists can conclude the lesion is likely malignant and perform a standard biopsy to investigate further. The results from the tests help guide doctors in their decisions surrounding the need for future in-office procedures. “Testing for skin cancer with genomics non-invasively increases the diagnostic precision for a process that is often subjective. Besides, the DermTech Melanoma Test also facilitates effective skin examinations via telehealth, which is traditionally difficult due to the technical limitations that prohibit a clear view of the atypical lesion in question,” adds Dobak.

There’s a big difference between the subjective visual assessment and DermTech’s objective, genomic level DermTech Melanoma Test. The Test has a 99 percent negative predictive value (a negative test means that an individual doesn’t have the disease). Furthermore, in contrast to a biopsy, which evaluates only 1 to 2 percent of the mole, DermTech’s Smart Sticker captures cells from 100 percent of the mole’s surface. It looks for melanoma at the gene level, 10,000 times closer than the traditional biopsy care pathway. All in all, the DermTech Melanoma Test enhances the detection of melanoma by reducing unnecessary surgery and the probability of missing melanoma, all while improving the negative predictive value and enhancing the positive predictive value of the overall pathway.

Advancing Skin Cancer Treatment with Genomics

The company takes pride in being the first to bring genomics to the field of dermatology, particularly clinical dermatology. Alongside facilitating drops in the cost of a biopsy, the DermTech Melanoma Test improves the speed of patient care, particularly if a suspicious lesion is first noticed or addressed by a primary care provider rather than a dermatologist. In addition to its product offering, the company is recognized for high-quality clinical work. “We study our products extensively in clinical studies. We have 22 peer reviewed publications that have enrolled several patients and it is proven that our product truly identifies melanoma at the earlier stage much more accurately than the current pathway,” asserts Dobak.

Among the other factors that differentiate DermTech in the dermatology landscape is that the firm has raised enough capital, which gives it a competitive edge. Dobak further elaborates, “As a public company, we have been able to raise the capital that allows us to effectively bring our new technologies to the commercial stage.

Furthermore, we have tremendous R&D capabilities and very talented R&D professionals that are committed to significantly reduce unnecessary deaths from a potentially curable disease.” From a cultural perspective, DermTech’s team is very resilient and possesses a tremendous amount of grit. “We also pride ourselves in being agile and nimble. We are a genomics company, we deal with DNA but it is in our DNA that we always persevere. Our motto is: try, fail, pivot and learn,” adds Dobak.

Changing the Diagnostic Paradigm

Highlighting the efficacy of DermTech’s platform is a case study involving a young woman who had a mole on her lower leg. She visited a dermatologist who suspected it could be a melanoma after examining the mole and assessing her family history. However, she didn’t want to have a surgical biopsy and a scar on her lower leg. That is when the doctor suggested she take DermTech’s non-invasive test. “The result came back positive and it turned out to be an early stage melanoma. Our test helped her understand that her mole required further attention and she was able to get it treated on time,” mentions Dobak.

Such accomplishments and contributions have helped DermTech make a mark in the dermatology space. More recently, the firm doubled the size of its sales team and marketing teams in its quest to continue catering to its clients’ demands. Alongside, they also doubled the size of their commercial laboratory capacity, all in preparation to capture the tremendous market opportunity.

While DermTech is currently focused on the U.S., the firm has plans to expand internationally in the future. “We got our Medicare reimbursement in February of last year, and were going to do this big commercial expansion around that Medicare coverage policy. But then COVID happened and we had to pause it. Now that we are slowly resuming operations, we are looking forward to achieving full commercial scale,” remarks Dobak.

As a part of its plan for the future, the company is also slowly broadening its scope to primary care. DermTech also has a deep pipeline of new products that they expect to launch in the next 12 to 18 months. “We have two new products that we are excited about; they are a part of our skin cancer vertical. One will assess the UV damages done to the skin. Our genomic platform will give them the information they need to get rid of affected cells. We also have a product for non-melanoma skin cancer. In short, we are expanding our commercial sample processing capability and introducing new products into the marketplace,” wraps up Dobak.