ECRI Completes Evaluation of the Pigmented Lesion Assay (PLA), the Foundational Assay for the DermTech Melanoma Test (DMT)
14 Junho 2023 - 9:00AM
Business Wire
- Health insurance plans and health systems use
ECRI’s technology reviews to formulate coverage policies and
clinical protocols
DermTech, Inc. (NASDAQ: DMTK) (“DermTech” or the “Company”), a
leader in precision dermatology enabled by a non-invasive skin
genomics platform, today announced that ECRI completed its
evaluation of the Pigmented Lesion Assay (PLA), the foundational
assay for the DermTech Melanoma Test (DMT), and changed its rating
from ‘Inconclusive’ to ‘Somewhat Favorable’. ECRI is an
independent, nonprofit organization focused on healthcare
technology evaluation and safety to improve quality, reduce cost
and achieve better outcomes across all healthcare settings.
“ECRI recently concluded an unbiased assessment of our clinical
data for the DMT,” said Chris Murphy, senior director of payer
access, DermTech. “ECRI determined that our test may inform
clinician decision-making to recommend surveillance rather than
biopsy for uncertain lesions with low melanoma risk. As health
insurance plans and health systems rely on the independence and
precision of ECRI’s technology evaluations to inform coverage
policies and clinical protocols, we believe this is another
important step that encourages payers to recognize the value of our
test and resulting benefits to their membership and network
providers.”
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 its Smart StickersTM. 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.
About ECRI
ECRI is an independent, nonprofit organization improving the
safety, quality, and cost-effectiveness of care across all
healthcare settings. With a focus on technology evaluation and
safety, ECRI is respected and trusted by healthcare leaders and
agencies worldwide. Over the past fifty-five years, ECRI has built
its reputation on integrity and disciplined rigor, with an
unwavering commitment to independence and strict
conflict-of-interest rules. ECRI is the only organization worldwide
to conduct independent medical device evaluations, with labs
located in North America and Asia Pacific. ECRI is designated an
Evidence-based Practice Center by the U.S. Agency for Healthcare
Research and Quality. ECRI and the Institute for Safe Medication
Practices PSO is a federally certified Patient Safety Organization
as designated by the U.S. Department of Health and Human Services.
The Institute for Safe Medication Practices (ISMP) formally became
an ECRI Affiliate in 2020. Visit www.ecri.org.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230614287299/en/
Steve Kunszabo DermTech (858) 291-1647
steve.kunszabo@dermtech.com
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