DermTech Simplifies the DermTech Melanoma Test (DMT) by Discontinuing the Optional TERT Add-on Assay
January 16 2024 - 8:05AM
Business Wire
- Trust 2 Study confirms negative predictive
value (NPV) of 99.7% for the foundational gene expression assay
- Optional TERT promoter mutation testing does
not significantly alter sensitivity, NPV or positive predictive
value (PPV)
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240116386434/en/
Steve Kunszabo DermTech (858) 291-1647
steve.kunszabo@dermtech.com
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