DermTech Announces Inclusion of Non-Invasive Genomic Patch Testing in the National Comprehensive Cancer Network® (NCCN) Cuta...
13 January 2021 - 8:01AM
Business Wire
DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in
precision dermatology enabled by a non-invasive skin genomics
platform, announced today that non-invasive genomic patch testing
for melanoma, like DermTech’s Pigmented Lesion Assay (“PLA”), has
received a recommendation from the National Comprehensive Cancer
Network® (“NCCN”). The recommendation indicates that there
is uniform NCCN consensus that the intervention is appropriate. The
NCCN Clinical Practice Guidelines in Oncology (the “NCCN
Guidelines®”) for cutaneous melanoma recognize the use of
noninvasive genomic patch testing to help guide biopsy decisions
for cutaneous melanoma.
The NCCN Guidelines® are the recognized standard for clinical
policy in cancer care and the most detailed clinical practice
guidelines available in any area of medicine. The recommendation
for pre-diagnostic non-invasive genomic patch testing can be found
in the latest edition, NCCN Guidelines® Version 1.21, Melanoma:
Cutaneous, section ME-11, Common Follow-Up Recommendations for All
Patients. The updated guidance now states: “Pre-diagnostic
noninvasive genomic patch testing may also be helpful to guide
biopsy decisions.”
As a not-for-profit alliance of 30 leading cancer centers, the
core resources made available by the NCCN are the NCCN Guidelines®.
These guidelines are decision tools created by leading clinicians
to explain a disease and help determine the best way to treat a
patient, depending on their diagnosis, disease stage and other
factors, such as age. The NCCN Guidelines® also help doctors make
decisions, by explaining the pros and cons of each option.
“I laud the NCCN for recognizing the value of non-invasive
genomic patch testing and including it in the current guidelines.
This non-invasive genomic patch testing is a revolutionary change
in the assessment of lesions suspicious for melanoma. Many
commercial payors rely on guidelines from organizations such as
NCCN as benchmarks for coverage decisions, and this NCCN
recommendation indicates there is consensus that recognizes the
value of the noninvasive genomic patch testing to guide biopsy
decisions,” said Daniel M. Siegel, M.D., Clinical Professor of
Dermatology at SUNY Downstate and former President of the American
Academy of Dermatology. “We are thrilled that the NCCN Guidelines®
recognize technology like DermTech’s as helpful in guiding biopsy
decisions and foster earlier melanoma detection,” said Burkhard
Jansen, M.D., chief medical officer of DermTech. “Using genomic
information provides clinicians with data even expert eyes cannot
see and benefits patients with skin lesions clinically suspicious
for melanoma. This is a significant milestone for precision
genomics, and further substantiates the utility of our DermTech
melanoma test, the Pigmented Lesion Assay, or PLA.”
Covering 97 percent of all cancers affecting patients in the
United States and updated on a continual basis, the NCCN
Guidelines® are developed through explicit review of evidence
(clinical trials, existing treatment protocol, etc.) integrated
with expert medical judgment and recommendations by panels that are
made up of representatives from the 30 NCCN Member
Institutions.
There are currently 73 NCCN Guidelines® available free-of-charge
that cover cancer detection, prevention and risk reduction, work-up
and diagnosis, treatment and supportive care issues. To download
the latest NCCN Guidelines®, please visit:
https://www.nccn.org/professionals/physician_gls/default.aspx
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 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 or continued 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 10Q 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/20210112005865/en/
Sarah Dion, MBA VP, Marketing sdion@dermtech.com
858.450.4222
Investor Relations: Caroline Corner, PhD Westwicke, an ICR
company caroline.corner@westwicke.com 415.202.5678
Crowe PR Sarah Gallagher sgallagher@crowepr.com 224.406.4709
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