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DermTech Presents Research Abstracts at the 2024 American Academy of Dermatology (AAD) Annual Meeting and New Research Published in the Journal of Investigative Dermatology

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DermTech, Inc. (DMTK) presents groundbreaking research at the 2024 AAD Annual Meeting, showcasing the ability of non-invasive gene expression analyses to rule out melanoma in patients with Fitzpatrick skin types IV-VI and detecting somatic mutations in healthy-appearing sun-exposed skin as an indicator of increased skin cancer risk.
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The research presented by DermTech at the AAD meeting regarding non-invasive gene expression analyses for melanoma detection in patients with darker skin types is a significant advancement in dermatology. The high negative predictive value (NPV) exceeding 99% for both Fitzpatrick skin type groups indicates a reliable method for ruling out melanoma, which is paramount since early detection is critical for patient prognosis. The efficacy of the DermTech Melanoma Test (DMT) across all skin types could potentially reduce disparities in melanoma outcomes, as darker-skinned individuals often face later diagnoses due to diagnostic challenges. The clinical implications of this are substantial, as it suggests that the DMT could be integrated into routine screenings, particularly for high-risk populations, potentially leading to earlier interventions and better survival rates.

The second study on somatic mutations in healthy-appearing sun-exposed skin represents a breakthrough in understanding skin cancer risk. By identifying genetic alterations at known cancer-associated hotspots such as TP53 and NOTCH1, the DNA-SCAR model provides a novel approach to assessing individual skin cancer risk beyond traditional clinical variables. This could revolutionize how we predict and prevent skin cancer, especially in populations with significant sun exposure. The ability to non-invasively assess genetic markers for cancer risk has vast potential for personalized medicine, allowing for targeted surveillance and preventative strategies tailored to an individual's genetic risk profile.

The implications of DermTech's research for the business landscape are notable. The precision dermatology sector is poised for growth and DermTech's innovative non-invasive testing could capture a significant market share. As the demand for personalized medicine and non-invasive diagnostics increases, DermTech's technology aligns well with these trends. The potential for the DMT to be adopted as a standard of care for melanoma screening could drive revenue growth and enhance the company's competitive edge. However, it is essential to monitor the adoption rate by clinicians and the possible integration of this technology into healthcare systems. The publication in the Journal of Investigative Dermatology further lends credibility to the research, which could positively influence investor perception and stock market performance, subject to peer review and clinical adoption.

SAN DIEGO--(BUSINESS WIRE)-- DermTech, Inc. (NASDAQ: DMTK) (DermTech or the Company), a leader in precision dermatology enabled by a non-invasive skin genomics technology, today announced the presentation of two research abstracts at the 2024 American Academy of Dermatology (AAD) Annual Meeting, taking place March 8th-12th in San Diego, California.

The first research abstract, “Non-invasive gene expression analyses to rule out melanoma in patients with Fitzpatrick skin types IV-VI” will be presented March 9th at 8:45am PT by Maral K. Skelsey, MD, lead author and Clinical Professor of Dermatology at Georgetown University’s Medical School. In this research, the negative predictive value (NPV) for both Fitzpatrick skin type group I-III and Fitzpatrick skin type group IV-VI was greater than 99%, and the 95% confidence interval indicated that there was no significant difference between the skin phototype groups.

“This real-world clinical study demonstrates that the DMT can help clinicians improve outcomes for cutaneous melanomas in patients of all skin types,” commented Dr. Skelsey. “This is especially important because ruling out melanoma in individuals with Fitzpatrick IV-VI skin types can be particularly challenging.”

The second research abstract titled, “Skin cancer risk is increased by somatic mutations detected noninvasively in healthy-appearing sun-exposed skin” will be presented March 9th at 10:05am PT by lead author John Whitaker, Ph.D., Senior Director of Bioinformatics at DermTech. The research found that somatic mutations in healthy-appearing sun-exposed skin indicate an increased risk for skin cancer. Furthermore, these mutations capture skin cancer risk information that is not accounted for by other risk factors.

A complete description of this research has been accepted for publication in the Journal of Investigative Dermatology and will be published on March 19th: (https://www.jidonline.org/article/S0022-202X(24)00176-3/fulltext)

This research study used non-invasively sampled DNA from healthy-appearing skin, in a reference cohort of 1,038 individuals, to measure the occurrence of somatic mutations at skin cancer-associated hotspots located within TP53 and NOTCH1. The number of detected mutations was combined with clinical variables known to be associated with skin cancer risk to create a skin cancer risk model (DNA-Skin Cancer Assessment of Risk, DNA-SCAR). DNA-SCAR’s risk calculation was validated by comparison to the U.S. population and was trained to predict personal history of skin cancer from age, family history, skin tone and mutation count.

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 technology. 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 using its Smart StickersTM. DermTech develops and markets products that facilitate the assessment of melanoma. 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,” ”aim,” “runway,” "outlook," “anticipate,” “intend,” “plan,” “strive," “may,” “will,” “sustain,” “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; expectations regarding DermTech’s potential growth, scale, patient reach, financial outlook, including its cash runway and future financial performance DermTech’s ability to increase its test volume, revenue and the proportion of reimbursed billable tests and control or reduce cost, expenses and cash burn, including as a result of DermTech’s recent restructuring actions; and expectations regarding agreements with or reimbursement or cash collection patterns from government payers (including Medicare) or commercial payers and related billing practices or number of covered lives. 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 capital when and as needed or on acceptable terms; (3) the existence of favorable or unfavorable clinical guidelines for DermTech’s tests; (4) the reimbursement of DermTech’s tests by government payers (including Medicare) 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; (9) DermTech’s ability to continue as a going concern and (10) 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.

Steve Kunszabo

DermTech

(858) 291-1647

steve.kunszabo@dermtech.com

Source: DermTech, Inc.

FAQ

What was presented by DermTech at the 2024 AAD Annual Meeting?

DermTech presented two research abstracts focusing on non-invasive gene expression analyses to rule out melanoma in patients with Fitzpatrick skin types IV-VI and detecting somatic mutations in healthy-appearing sun-exposed skin as an indicator of increased skin cancer risk.

Who presented the research abstract on ruling out melanoma in patients with Fitzpatrick skin types IV-VI?

The research abstract on ruling out melanoma in patients with Fitzpatrick skin types IV-VI was presented by Maral K. Skelsey, MD, Clinical Professor of Dermatology at Georgetown University’s Medical School.

What was the key finding of the research on ruling out melanoma?

The research showed a negative predictive value (NPV) greater than 99% for both Fitzpatrick skin type groups I-III and IV-VI, indicating the effectiveness of the non-invasive gene expression analyses.

Who presented the research abstract on detecting somatic mutations in healthy-appearing sun-exposed skin?

The research abstract on detecting somatic mutations in healthy-appearing sun-exposed skin was presented by John Whitaker, Ph.D., Senior Director of Bioinformatics at DermTech.

What was the outcome of the research on somatic mutations in sun-exposed skin?

The research found that somatic mutations in healthy-appearing sun-exposed skin are indicative of an increased risk for skin cancer, capturing risk information not covered by other factors.

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About DMTK

dermtech is a molecular diagnostic dermatology company focused on developing non-invasive gene expression tests to aid the clinical diagnosis of skin cancer and other skin conditions. dermtech operates a clia (clinical laboratory improvement amendments) licensed laboratory located at the company’s la jolla, ca headquarters. dermtech’s technology allows for the analysis of skin biopsy samples collected non-invasively using an adhesive patch. current dermatologic diagnosis is primarily based on subjective visual pattern recognition that is prone to error and results in a substantial number of unnecessary surgical procedures. dermtech’s pigmented lesion assay (pla) provides physicians with a non-invasive option for the biopsy of clinically atypical pigmented lesions using an adhesive patch rather than a scalpel. dermtech provides highly accurate, objective information to the physician to improve patient care and comfort and reduce costs. the pla is used for the detection of melanoma in at