LINC00518

- Study demonstrated the DMT’s effectiveness as a melanoma rule-out test for all skin types - Negative predictive value (NPV) higher than 99% regardless of skin type SAN DIEGO--(BUSINESS WIRE)-- DermTech International (NASDAQ: DMTK) (DermTech or the Company), a leader in precision dermatology enabled by a non-invasive skin genomics technology, today reported positive topline results from a study evaluating the foundational gene expression assay component of the DermTech Melanoma Test (DMT) across all skin types in the real-world clinical setting. The peer-reviewed study entitled, “Non-invasive gene expression analysis rules out melanoma with high negative predictive value regardless of skin phototype” was presented at the Winter Clinical Dermatology Conference (January 12-17, 2024). Using follow-up information and biopsy results from a large registry database that also served as the basis for the Company’s recently completed Trust 2 Study, this study compared the DMT’s performance in patients with Fitzpatrick skin phototypes I-III (n=4,152) to its performance in patients with skin phototypes IV-VI (n=130). As in prior DMT studies, lesions on acral skin (palms, soles and nailbeds) were excluded because the thicker skin on acral sites may interfere with the test’s non-invasive sample collection method. The negative predictive value (NPV) for both groups (I-III and IV-VI) was greater than 99%, and the 95% confidence interval for the difference in NPV between the groups indicated that there was no significant difference between the skin phototype groups. Additional analysis limited to subjects with re-examination of DMT-negative lesions at least 6 months after testing confirmed the results observed in the full cohort. These data establish that the DMT’s performance does not vary across Fitzpatrick skin types. “This study demonstrated that regardless of a patient’s skin type, the DMT can help clinicians rule out melanoma non-invasively, with an NPV of over 99%,” said Loren Clarke, M.D., chief medical officer, DermTech. “A high NPV means a suspicious pigmented lesion that tests negative is unlikely to be a melanoma. The DMT provides genomic information that can help guide biopsy decisions for suspicious pigmented lesions across all skin types.” “This study shows that the DMT can help clinicians improve outcomes for cutaneous melanomas in patients of all skin types,” commented Neal Bhatia, M.D., director of Therapeutics Clinical Research and a co-author of the study. “This is significant progress toward making this test available for patients with Fitzpatrick skin types IV-VI, which is important because ruling out melanoma in individuals with these skin types can be particularly challenging.” 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 an add-on assay to the PLA in 2021, 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 99% probability that the mole tested is not melanoma. Effective March 1, 2024, the Company will discontinue the optional TERT promoter mutation add-on assay to simplify the DMT, which will thereafter consist of the foundational gene expression assay for LINC and PRAME. 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,” “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; 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 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 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; 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.

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 that it will discontinue the optional TERT promoter mutation add-on assay for its DermTech Melanoma Test (DMT) effective March 1, 2024. Multiple studies, including the Company’s recently completed Trust 2 Study, demonstrated the DMT’s negative predictive value (NPV) to be 99% or higher. A high NPV for a rule-out test provides assurance to clinicians and patients that a suspicious pigmented lesion which tests negative is unlikely to be a melanoma. The TERT promoter mutation assay was offered as an optional add-on to the foundational gene expression assay for LINC00518 and PRAME based on initial validation data suggesting it conferred a modest increase in NPV. However, in the clinical setting, less than one-third of patient samples contain sufficient genomic material for TERT analysis. In the Trust 2 Study, the addition of TERT analysis decreased specificity slightly without providing a statistically significant increase in NPV. “ Clinician feedback, in addition to the Trust 2 Study results, suggests that the TERT promoter mutation add-on assay has limited impact on decision-making when evaluating pigmented lesions for melanoma,” said Loren Clarke, M.D., chief medical officer, DermTech. “ The DMT will now consist of the foundational gene expression assay for LINC00518 and PRAME. With an NPV that remains at 99% or higher, the DMT provides genomic information for a suspicious pigmented lesion that a clinician may be hesitant to biopsy for various reasons.” “ These findings establish in a large real-world cohort that the DMT’s high NPV is not enhanced by the addition of TERT mutation testing,” commented Laura K. Ferris, M.D., Ph.D., Professor of Dermatology, University of Pittsburgh School of Medicine, and a participant in the study. 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 an add-on assay to PLA in 2021, 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 99% probability that the mole 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 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 Stickers™. 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,” “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; 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 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 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; 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.

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 reported positive topline results from its Trust 2 Study, which evaluated the foundational gene expression assay component of the DermTech Melanoma Test (DMT) in a real-world clinical setting. “ The Trust 2 Study results reaffirm the DMT’s real-world clinical utility to rule out melanoma with a negative predictive value (NPV) that is higher than other currently available methods,” said Loren Clarke, M.D., chief medical officer, DermTech. “ Importantly, for clinicians and patients, a high NPV delivers assurance that a suspicious pigmented lesion which tests negative is unlikely to be a melanoma. As a non-invasive test that has demonstrated an NPV of 99% or higher in multiple, large studies, the DMT provides actionable genomic information for a suspicious pigmented lesion that a clinician may be hesitant to biopsy for a variety of reasons.” Dr. Clarke continued, “ The DMT may also help clinicians avoid biopsies and other procedures for benign lesions and thereby reduce healthcare costs. Finally, we believe these positive results will support re-engagement with payers as they consider reimbursement for the DMT.” The Trust 2 Study, initiated in 2021, enrolled over 20,000 patients tested with the DMT in a real-world clinical setting. Follow-up evaluations occurred for more than 5,000 tested lesions, with median and mean follow-up durations of 348 days and 337 days, respectively. Follow-up evaluations included pathology diagnoses for lesions that were biopsied, and visual re-examination for lesions that were monitored rather than biopsied, in which the lesion was classified as either stable/unchanged or changed in a manner concerning for melanoma. The Trust 2 Study results demonstrated an NPV of 99.7% for the foundational gene expression assay component of the DMT. The NPV of 99.7% was observed (rather than calculated from an assumed prevalence), and was associated with a narrow 95% confidence interval of 99.5% to 99.9%. The Trust 2 Study results also included a sensitivity of 95.8%, a specificity of 69.4% and a positive predictive value (PPV) of 13.4%. The Trust 2 Study results further validate the 99% NPV observed in a similar real-world study (Trust 1) published in 2021, which evaluated the tested lesions of more than 1,500 patients. “ The Trust 2 Study illustrates that a high NPV test such as the DMT can allow physicians to confidently rule out melanoma for their patients,” commented Maral K. Skelsey, M.D., Clinical Professor of Dermatology at Georgetown University’s Medical School and one of the lead Trust 2 Study investigators. “ Our clinic at the Dermatologic Surgery Center of Washington in Chevy Chase has used the DMT more than 5,400 times. Patients love the test’s non-invasive sample collection. It’s clear there is a place for the DMT in every dermatologic practice alongside established protocol.” 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 an add-on assay to the PLA in 2021, 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 99% probability that the mole 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 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 Stickers™. 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,” “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; and expectations regarding agreements with or reimbursement by or cash collection patterns from government payers (including Medicare) and 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 including 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.