DermTech Announces Topline Results of its TRUST Study: Results Confirm the High Negative Predictive Value of the PLA at 99% &...
December 17 2020 - 3:30PM
Business Wire
DermTech, Inc. (NASDAQ: DMTK) (“DermTech”), a leader in
precision dermatology enabled by a non-invasive skin genomics
platform, announced today the topline results from its TRUST Study
of the company’s non-invasive melanoma rule-out test, the Pigmented
Lesion Assay (the “PLA”). The TRUST study is a long-term follow-up
study of pigmented skin lesions that tested negative for melanoma
with the PLA. It was designed to assess long-term outcomes of PLA
negative tests and to further confirm the 99% negative predictive
value (“NPV”) of the PLA. Specifically, the study protocol called
for reevaluating and retesting lesions that were PLA negative 12 to
24 months prior to each subject’s enrollment in the TRUST Study in
order to determine the proportion of true negative lesions among
those that tested negative. The PLA enhances early melanoma
detection by assessing atypical pigmented lesions (lesions
suspicious for melanoma) to help rule out melanoma and the need for
surgical evaluation. The PLA detects LINC 518 (long intergenic
non-protein coding RNA 518) and PRAME (preferentially expressed
antigen in melanoma) as a 2-panel gene expression assay.
The TRUST Study was conducted at five geographically distinct
clinical sites in the U.S. that consistently use the PLA to help
manage atypical pigmented lesions in their clinical practice. A
long-term follow-up cohort of 1,781 lesions with PLA negative tests
in a 12 to 24 month period prior to the study’s start were
identified and the subjects with such lesions were solicited to
return for repeat PLA testing on the same lesion. A total of 302
lesions were evaluated by means of repeat testing with the PLA,
meeting the study protocol’s pre-specified enrollment target.
After the enrollment of subjects in the repeat testing arm of
the TRUST Study, the NPV and patient outcomes for the full cohort
of eligible lesions was established via a prospectively planned
chart review for any melanoma diagnoses on the PLA tested lesion,
late-stage melanoma diagnoses, and melanoma mortality. Of the 1,781
lesions in the long-term follow-up cohort, there were no melanoma
deaths or late-stage melanoma diagnoses reported in the full
cohort. Ten lesions from the full cohort had received a melanoma
diagnosis after initial testing, with four at Stage 0 (in situ) and
six at Stage 1a. A subset of the full cohort, representing 1,233
lesions, had confirmed follow-up evaluations from the initial PLA
negative test, and from these evaluations we calculate an NPV of
99.2% (CI95%= 98.5 - 99.6).
Of the 302 lesions evaluated by means of repeat testing with the
PLA, none (0%) were found to have clinically obvious melanoma upon
the subject’s return to the clinic, confirming the results of the
initial chart review. Eighty-nine percent of these lesions (268
lesions) were negative on repeat testing with the PLA and 34
(11.2%) were positive. Positive lesions were biopsied and subjected
to a single read histopathologic review. Three lesions (1%) that
tested positive on repeat testing were diagnosed as Stage 0, in
situ. Photographic review of the three Stage 0 cases identified
changes in clinical appearance since the initial test. The
pathology reports from the remaining biopsied lesions indicated a
variety of non-melanoma diagnoses, including compound nevi with
mild to moderate atypia. Given the early stage (in situ) of the
melanomas detected on repeat testing, and length of time from the
initial test (an average of 15 months), it is difficult to
determine whether these melanomas evolved after the initial test or
were present at the time of the initial test. In any case, the
finding of three melanomas in a cohort of 302 lesions subjected to
repeat testing further confirms an NPV of the PLA of at least 99.0%
(CI95% = 97.1 - 99.8) and is consistent with the results from the
full long-term follow‑up cohort. These results exemplify how PLA
repeat testing of lesions that may have evolved over time after the
initial negative PLA test, can identify early-stage melanoma and
benefit patients.
“These results further support the PLA’s high negative
predictive value in routine‑use scenarios and the test’s ability to
enhance early melanoma detection. Clinicians should have confidence
in the PLA as the long‑term follow-up of PLA negative tests
observed in the TRUST Study did not reveal any adverse outcomes,”
stated Dr. Burkhard Jansen, DermTech’s CMO.
“The TRUST Study illustrates that the PLA can identify melanoma
at the earliest stages to maximize patient benefit,” commented Dr.
Maral Skelsey, Director of the Mohs Surgery Unit and Clinical
Associate Professor of Dermatology at Georgetown University and one
of the TRUST study investigators.
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 the practice of dermatology through more accurate
diagnosis and treatment, and the elimination of unnecessary
surgery, leading to improved patient care and lower costs. 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/20201217006028/en/
DermTech Sarah Dion sdion@dermtech.com 858.450.4222 Crowe PR
Sarah Gallagher sgallagher@crowepr.com 224.406.4709
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