DermTech Surpasses 200,000 Cumulative Billable Samples for the DermTech Melanoma Test (DMT)

Rhea-AI Summary

DermTech's Melanoma Test surpasses 200,000 cumulative billable samples, with a negative predictive value of over 99 percent. The test uses non-invasive Smart Stickers™ to detect genomic markers associated with melanoma. The company aims to further integrate the test into the melanoma care pathway.

Positive

• DermTech's Melanoma Test has tested over 200,000 suspicious pigmented lesions, indicating high usage and potential for future growth. The test improves patient care and can potentially save lives. Approximately one-third of U.S. dermatologists ordered the test in 2022.

Negative

• None.

SAN DIEGO--(BUSINESS WIRE)-- DermTech, Inc. (NASDAQ: DMTK) (“DermTech” or the “Company”), a leader in precision dermatology enabled by a non-invasive skin genomics platform, today announced that the DermTech Melanoma Test (DMT) has tested more than 200,000 suspicious pigmented lesions. The DMT uses non-invasive Smart Stickers™ to test for select genomic markers associated with melanoma, one of the deadliest forms of skin cancer. With a negative predictive value of over 99 percent, the test rules out melanoma with high probability.

“We are proud to have surpassed 200,000 cumulative billable samples for the DMT,” said Bret Christensen, CEO, DermTech. “Our test improves patient care and can potentially save lives. Our dedicated team and healthcare provider partners were instrumental in achieving this goal, as few medical technologies reach this level of usage. Approximately one-third of U.S. dermatologists ordered the DMT in 2022. We are building momentum and expect to further integrate the DMT into the melanoma care pathway.”

“I am grateful to our exceptional lab team for their hard work in helping us achieve this significant milestone,” said Claudia Ibarra, chief operating officer, DermTech. “While we have already made significant strides, our new, state-of-the-art facility in San Diego is the foundation of our future growth. We are well-positioned to further transform dermatology with our non-invasive technology.”

“The DMT has entirely changed how I evaluate suspicious lesions on my patients and enabled me to reduce the number of biopsies I perform,” said Dr. Maral Kibarian Skelsey, director of the Dermatologic Surgery Center of Washington. “This is critical because so many of my patients are extremely hesitant to be cut. With the DMT, I can reliably rule out melanoma in a non-invasive manner, all while ensuring the highest quality of patient safety and care.”

“I have had four melanomas throughout my life,” said Helen Fry, a patient who has been tested with the DMT many times. “Before I was introduced to the DMT, I knew that a trip to the dermatologist meant that I would almost certainly be cut. Not only was this anxiety-inducing, but it sometimes led me to postpone necessary appointments. The DMT has changed my life for the better.”

This milestone announcement comes during Melanoma Awareness Month, amidst DermTech’s third annual #Stickit2Melanoma campaign aimed at raising awareness of melanoma and promoting the importance of scheduling regular skin exams. For every #Stickit2Melanoma pledge to schedule a skin exam made during May, DermTech will donate $5 to its non-profit partner organizations. To find a specialist to schedule a skin exam, visit https://dermtech.com/pledge/.

About The DermTech Melanoma Test

DermTech originally marketed its foundational assay under the name Pigmented Lesion Assay (PLA). The PLA assesses pigmented skin lesions, moles or dark skin spots for melanoma. In particular, the PLA detects expression of the LINC00518 (LINC) and preferentially expressed antigen in melanoma (PRAME) genes using reverse transcription-polymerase chain reaction (RT-PCR). The Company introduced its second-generation test in 2021 as an add-on assay to PLA, which is designed to identify the presence of mutations in TERT gene promoter region using DNA sequencing. The Company has since branded its PLA and TERT add-on-assay as the DermTech Melanoma Test (DMT). The DMT may be ordered with or without the add-on test for TERT. Positive results for LINC, PRAME or TERT correlate with a lesion at higher risk for melanoma. If none of the biomarkers are detected, this result indicates a greater than 99% probability that the mole being tested is not melanoma.

About DermTech

DermTech is a leading genomics company in dermatology and is creating a new category of medicine, precision dermatology, enabled by its non-invasive skin genomics platform. DermTech’s mission is to improve the lives of millions by providing non-invasive precision dermatology solutions that enable individualized care. DermTech provides genomic analysis of skin samples collected non-invasively using our Smart Stickers™. 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, please visit DermTech.

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,” "outlook," “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations and evaluations with respect to: the performance, patient benefits, cost- effectiveness, commercialization and adoption of DermTech’s products and the market opportunity for these products, DermTech’s positioning and potential growth, financial outlook and future financial performance, ability to monetize existing demand by increasing its proportion of reimbursed billable samples, ability to maintain or improve its operating efficiency and reduce operating expenses, the sufficiency of DermTech’s cash resources and runway and ability to access capital to fund its operating plan, implications and interpretations of any study results, expectations regarding agreements with or reimbursement or cash collection patterns from Medicare, government payers or commercial payers and related billing practices or number of covered lives and DermTech’s ability to expand its product offerings and develop pipeline products. 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, government payers and commercial payers; (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 and maintain or improve its operating efficiency and reduce operating expenses; (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 the “Risk Factors” section of the most recent Annual Report on Form 10-K filed by DermTech with the Securities and Exchange Commission (the “SEC”), and other documents filed or to be filed by DermTech with the SEC, including subsequently filed reports. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230531005243/en/

Steve Kunszabo

DermTech

(858) 291-1647

steve.kunszabo@dermtech.com

Source: DermTech, Inc.

FAQ

What is the DermTech Melanoma Test?

The DermTech Melanoma Test is a non-invasive test that uses Smart Stickers™ to detect genomic markers associated with melanoma, a deadly form of skin cancer.

What is the negative predictive value of the test?

The DermTech Melanoma Test has a negative predictive value of over 99 percent, meaning it can rule out melanoma with high probability.

How many suspicious pigmented lesions has the test been used on?

The DermTech Melanoma Test has tested over 200,000 suspicious pigmented lesions.

How many U.S. dermatologists ordered the test in 2022?

Approximately one-third of U.S. dermatologists ordered the DermTech Melanoma Test in 2022.

What is the goal of DermTech's #Stickit2Melanoma campaign?

DermTech's #Stickit2Melanoma campaign aims to raise awareness of melanoma and promote the importance of scheduling regular skin exams. For every pledge made to schedule a skin exam during May, DermTech will donate $5 to its non-profit partner organizations.