DermTech Pigmented Lesion Assay (PLA) to Enrich Melanoma Positivity Nearly Five-Fold in Biopsied Lesions: Findings from a Lar...
January 14 2021 - 4:30PM
Business Wire
DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in
precision dermatology enabled by a non-invasive skin genomics
platform, announced today that SKIN has published the results of a
large registry study finding that the evaluation of genomic atypia
using DermTech’s Pigmented Lesion Assay (the “PLA”) may be a
superior approach to guide treatment decisions and manage pigmented
lesions, when compared to visual assessment of pigmented
lesions.
Melanoma is a life-threatening skin cancer where early detection
and intervention can significantly improve clinical outcomes and
eliminate disease. An estimated 196,060 cases of melanoma were
expected to be diagnosed in the United States in 2020 and expected
to cause approximately 6,850 deaths, many of which could have been
prevented through early detection.
The study, “Genomic Atypia to Enrich Melanoma Positivity in
Biopsied Lesions: Gene Expression and Pathology Findings – A Large
U.S. Registry,” reports that lesions biopsied based on genomic
atypia criteria identified by the PLA were associated with a nearly
five-fold enrichment of melanoma in the patient specimens compared
to those biopsied based solely on visual assessment criteria. This
is the 20th peer-reviewed publication supporting use of the PLA to
better guide treatment decisions.
This large, year-long registry study conducted in the U.S.
included 90 providers across 53 dermatology offices and assessed
3,418 pigmented lesions clinically suspicious for melanoma using
the PLA. PLA-positive lesions were then biopsied using standard
pathological methods. Pathology reports for 313 of 316 PLA-positive
cases biopsied to rule out melanoma based on genomic atypia were
available for subsequent analysis by the research team. The results
of the study demonstrate that:
- Overall, 18.7% (59/316) of PLA positive lesions were
histopathologically diagnosed as melanomas with 14.9% (47/316)
diagnosed as melanomas in situ and 3.8% (12/316) as invasive
melanomas.
- 47.5% of the histopathologically-confirmed melanomas
demonstrated a double positive genomic signature (LINC and PRAME)
while 23.7% were single-positive for LINC and 28.8% were
single-positive for PRAME.
- Gene expression of both LINC and PRAME was present in
increasing percentages of melanocytic lesions, corresponding with
pathology reports showing increasing levels of atypia.
The published findings in SKIN can be found here:
https://jofskin.org/index.php/skin/article/view/1146
Dr. Brook Brouha, M.D., Ph.D., the study’s lead author
commented, “I start every skin exam with a visual clinical
inspection. When I find difficult borderline lesions, the PLA’s
objective genomic information informs my treatment decision. I now
detect more early-stage melanomas with fewer invasive
procedures.”
“There is clear patient and clinician benefit when genomic
atypia information is added to visual inspection to guide biopsy
decisions and enhance early melanoma detection. Patients love the
additional peace of mind that the high performance of the PLA
offers, and they also appreciate not being cut when avoidable,”
added Burkhard Jansen, M.D., DermTech’s chief medical officer.
About DermTech
DermTech is the leading genomics company in dermatology and is
creating a new category of medicine, precision dermatology, enabled
by our non-invasive skin genomics platform. DermTech’s mission is
to transform dermatology with our non-invasive skin genomics
platform, to democratize access to high quality dermatology care,
and to improve the lives of millions. DermTech provides genomic
analysis of skin samples collected non-invasively using an adhesive
patch rather than a scalpel. 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 on DermTech, please
visit DermTech’s investor relations site at: www.DermTech.com.
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,”
“anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,”
“believes,” “predicts,” “potential,” “continue,” and similar
expressions are intended to identify such forward-looking
statements. These forward-looking statements include, without
limitation, expectations with respect to: the performance, patient
benefits, cost-effectiveness, commercialization and adoption of
DermTech’s products, including the Smart Sticker platform, and the
market opportunity therefor. 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 and private payors; (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; (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 (x) the “Risk Factors” section of the
most recent Quarterly Report on Form 10-Q filed by DermTech with
the Securities and Exchange Commission (the “SEC”), and (y) other
documents filed or to be filed by DermTech with the SEC. 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/20210114005840/en/
DermTech Sarah Dion sdion@dermtech.com 858.450.4222
Crowe PR Sarah Gallagher sgallagher@crowepr.com 224.406.4709
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