Castle Biosciences Announces Publication Demonstrating Dermatologists Are Increasingly Integrating DecisionDx-Melanoma Into M...
26 March 2021 - 8:00AM
Business Wire
Cross-Sectional Study of 589 U.S.
Dermatological Clinicians Demonstrating Clinical Utility Was
Recently Published in SKIN: The Journal of Cutaneous Medicine
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer
diagnostics company providing personalized genomic information to
improve cancer treatment decisions, today announced the publication
of a cross-sectional study of dermatologists that found its
respondents are increasingly incorporating DecisionDx®-Melanoma
into the management of their patients with melanoma.
DecisionDx-Melanoma is Castle’s gene expression profile test that
uses an individual patient’s tumor biology to predict individual
risk of cutaneous melanoma metastasis or recurrence, as well as
sentinel lymph node positivity, independent of traditional staging
factors.
The article, titled “Assessment of the 31-Gene Expression
Profile Test by Dermatologists: A Cross-Sectional Survey from
National Dermatology Conferences,” was published in SKIN: The
Journal of Cutaneous Medicine. The cross-sectional study was
offered to attendees of two national, virtual dermatology
conferences during the end of 2020 and beginning of 2021 to assess
the professional understanding, opinions and clinical usage of
DecisionDx-Melanoma by dermatologists. Participants were asked
questions regarding practice demographics, factors considered prior
to ordering DecisionDx-Melanoma, their integration of the test’s
results into clinical management and their opinions on the
usefulness of the test.
Data from 589 U.S. dermatological clinicians showed:
- 45% of participants ordered the DecisionDx-Melanoma test in the
prior twelve months.
- Going forward, 82% of participants were “somewhat to very
likely” to order the test, with 66% stating they would recommend
the test to a friend or family member as part of their melanoma
care.
- In melanomas less than or equal to 1.0mm (T1), which make up
the majority of melanomas, previous studies have demonstrated that
a DecisionDx-Melanoma Class 1A test result (lowest risk) has a
5-year recurrence free survival rate of 96.8%, compared to 64.6%
for a Class 2B test result (highest risk). 61% of participants
stated they would change their treatment plan in this T1 population
with a Class 2B test result.
- Participants who use DecisionDx-Melanoma indicated that they
use the results to impact follow-up schedules, referrals,
surveillance imaging, sentinel lymph node biopsy procedure
recommendations and other treatment decisions. These uses largely
follow published appropriate-use criteria for the test.
- Participants responded that patients gain various benefits from
DecisionDx-Melanoma test results, including increased knowledge and
understanding (70%), personalized treatment options (58%) and eased
uncertainty about the future (59%). Even regarding test results
indicating the lowest risk of recurrence (i.e. Class 1A), 66% of
participants reported potential benefits for ameliorating patients’
anxiety and 46% reported increasing confidence in their
management.
“The sample surveyed demonstrated that dermatology specialists
are using DecisionDx-Melanoma in increased numbers, and concluded
that melanoma patients whose healthcare providers incorporate
DecisionDx-Melanoma into their practice may benefit from decreased
anxiety and uncertainty from the improved prognosis, reduced need
for unwarranted procedures and optimized healthcare resources for
patients who need it most,” said study author, Darrell Rigel, M.D.,
M.S., Clinical Professor at New York University School of
Medicine.
About DecisionDx-Melanoma
DecisionDx®-Melanoma is a gene expression profile test that uses
an individual patient’s tumor biology to predict individual risk of
cutaneous melanoma metastasis or recurrence, as well as sentinel
lymph node positivity, independent of traditional staging factors,
and has been studied in more than 5,700 patient samples. Using
tissue from the primary melanoma, the test measures the expression
of 31 genes. The test has been validated in four archival risk of
recurrence studies of 901 patients and six prospective risk of
recurrence studies including more than 1,600 patients. To predict
likelihood of sentinel lymph node positivity, the Company utilizes
its proprietary algorithm, i31-GEP, to produce an integrated test
result. i31-GEP is an artificial intelligence-based neural network
algorithm (independently validated in a cohort of 1,674
prospective, consecutively tested patients with T1-T4 cutaneous
melanoma) that integrates the DecisionDx-Melanoma test result with
the patient’s traditional clinicopathologic features. Impact on
patient management plans for one of every two patients tested has
been demonstrated in four multicenter and single-center studies
including more than 560 patients. The consistent performance and
accuracy demonstrated in these studies provides confidence in
disease management plans that incorporate DecisionDx-Melanoma test
results. Through December 31, 2020, DecisionDx-Melanoma has been
ordered more than 68,920 times for use in patients with cutaneous
melanoma.
More information about the test and disease can be found at
www.CastleTestInfo.com.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a commercial-stage
dermatologic cancer company focused on providing physicians and
their patients with personalized, clinically actionable genomic
information to make more accurate treatment decisions. The Company
currently offers tests for patients with cutaneous melanoma
(DecisionDx®-Melanoma, DecisionDx®-CMSeq), cutaneous squamous cell
carcinoma (DecisionDx®-SCC), suspicious pigmented lesions
(DecisionDx® DiffDx™-Melanoma) and uveal melanoma (DecisionDx®-UM,
DecisionDx®-PRAME and DecisionDx®-UMSeq). For more information
about Castle’s gene expression profile tests, visit
www.CastleTestInfo.com. Castle also has active research and
development programs for tests in other dermatologic diseases with
high clinical need. Castle Biosciences is based in Friendswood,
Texas (Houston), and has laboratory operations in Phoenix, Arizona.
For more information, visit www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC,
DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and
DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
The information in this press release contains forward-looking
statements and information within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, which are subject to
the “safe harbor” created by those sections. These forward-looking
statements include, but are not limited to, statements concerning
DecisionDx-Melanoma’s ability to provide benefits to patients
including decreasing anxiety and uncertainty from enhanced
prognosis, decreasing the need for potentially unnecessary
procedures such as sentinel lymph node biopsy (SLNB) surgery,
optimizing the allocation of healthcare resources, increasing
knowledge and understanding of the prognoses, personalizing
treatment options and increasing confidence in their treatment
management, as well as its ability to determine referrals/follow-up
frequency and inform discussions regarding potential SLNB surgery.
The words “anticipates,” “believes,” “estimates,” “expects,”
“intends,” “may,” “plans,” “projects,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. We may not actually achieve the plans,
intentions, or expectations disclosed in our forward-looking
statements and you should not place undue reliance on our
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements that we make. These forward-looking
statements involve risks and uncertainties that could cause our
actual results to differ materially from those in the
forward-looking statements, including, without limitation, the
effects of the COVID-19 pandemic on our business and our efforts to
address its impact on our business, subsequent study results and
findings that contradict earlier study results and findings,
DecisionDx-Melanoma’s ability to provide the aforementioned
benefits to patients and the risks set forth in our Annual Report
on Form 10-K for the year ended December 31, 2020, and in our other
filings with the SEC. The forward-looking statements are applicable
only as of the date on which they are made, and we do not assume
any obligation to update any forward-looking statements, except as
may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210325005768/en/
Investor and Media Contact: Camilla Zuckero 832-835-5158
czuckero@castlebiosciences.com
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