DermTech Announces Positive Topline Results From a Study Evaluating the DermTech Melanoma Test (DMT) Across All Skin Types
January 18 2024 - 8:05AM
Business Wire
- 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
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240118227155/en/
Steve Kunszabo DermTech (858) 291-1647
steve.kunszabo@dermtech.com
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