Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, will
present new data on its gene expression profile (GEP)
risk-stratification test for patients with cutaneous squamous cell
carcinoma (SCC), DecisionDx®-SCC, and its GEP risk-stratification
test for patients with cutaneous melanoma (CM),
DecisionDx®-Melanoma, at the American Head & Neck Society’s
(AHNS) 11th International Conference on Head and Neck Cancer, being
held July 8-12 in Montréal, QC, Canada.
Castle’s podium presentation on DecisionDx-SCC will share data
demonstrating significantly improved metastatic risk prediction in
patients with SCC of the head and neck (SCC-HN) when the test’s
results are used both independently and in conjunction with
American Joint Committee on Cancer 8th edition (AJCC8) and Brigham
and Women's Hospital (BWH) staging systems. Details are as
follows:
Abstract ID: 128656 | Podium presentation:
Improved metastatic risk prediction with the 40-gene expression
profile (40-GEP) test supports its use for risk-aligned decision
making for patients with high-risk cutaneous squamous cell
carcinoma of the head and neck Presenter and Study Author:
Jason G. Newman, M.D., F.A.C.S., Department of Otolaryngology Head
and Neck Surgery at Medical University of South Carolina Session
Date/Time: Sunday, July 9, 1:45-3:15 p.m. Eastern time
Session Name: Proffered Papers 9 - Skin 1 and Hot Topic
Session
“Traditional staging methods rely on a limited set of
clinicopathologic risk factors to categorize cancer patients into
different stages,” said Newman. “While these factors provide
important information, they may not fully capture the underlying
biological heterogeneity and variability in tumor behavior. The
study data demonstrated that using DecisionDx-SCC test results in
combination with these traditional staging approaches can improve
prognostic accuracy to help optimize and personalize treatment
choices based on a patient's unique, biological risk profile.”
This multi-center study expands on a previously published study1
and analyzed data from 622 patients with high-risk SCC-HN. In the
study, DecisionDx-SCC significantly stratified patients according
to their biologic risk of metastasis, independent of the
clinicopathologic risk factors used in AJCC8 and BWH staging
systems (p<0.0001). Additionally, the metastatic risk
predictions provided by AJCC8 and BWH staging were significantly
improved when DecisionDx-SCC test results were included. The data
show that DecisionDx-SCC contributes independent prognostic value
to the prediction of metastatic risk in SCC-HN patients, relative
to staging alone, which can help clinicians make informed decisions
regarding treatment and follow-up care. These may include closer
monitoring, more frequent imaging scans and the timely initiation
of adjuvant treatments to mitigate metastatic risk and improve
patient outcomes.
Castle will also present a poster highlighting data from a large
study of real-world, unselected patients with head and neck CM
(n=985) showing that combining DecisionDx-Melanoma test results
with AJCC8 staging significantly improved risk prediction over
either alone.
Abstract ID: 128718 | Poster presentation: The
31-gene expression profile test stratifies melanoma-specific
survival among patients with head and neck cutaneous melanoma
tumors: A Surveillance, Epidemiology, and End Results (SEER)
Program Collaboration Presenter and Study Author: Matthew
Goldberg, M.D., Senior Vice President, Medical, Castle Biosciences
Poster Viewing Dates and Times:
- Sunday, July 9, 5:15-6:45 p.m. (Welcome Reception)
- Monday, July 10, 10 a.m. – 4 p.m. and 5:30-7 p.m. (Wine and
Cheese Poster Walk)
- Tuesday, July 11, 10 a.m. – 4 p.m.
In the study, DecisionDx-Melanoma testing and AJCC8 staging were
independent predictors of mortality. The DecisionDx-Melanoma test
classified 40% of the patients as having an increased risk of dying
from their disease (Class 1B-2B test result) compared to 15% who
were classified as having an increased risk by AJCC8 staging
(IIB-III). Overall, the data demonstrated that combining the test’s
results with AJCC8 staging significantly improved risk prediction
over use of either alone, providing actionable information that can
enable risk-aligned patient care.
About DecisionDx®-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an
individual patient’s tumor biology to predict individual risk of
cutaneous squamous cell carcinoma metastasis for patients with one
or more risk factors. The test result, in which patients are
stratified into a Class 1 (low), Class 2A (moderate) or Class 2B
(high) risk category, predicts individual metastatic risk to inform
risk-appropriate management. Peer-reviewed publications have
demonstrated that DecisionDx-SCC is an independent predictor of
metastatic risk and that integrating DecisionDx-SCC with current
prognostic methods can add positive predictive value to clinician
decisions regarding staging and management.
About DecisionDx®-Melanoma
DecisionDx-Melanoma is a gene expression profile risk
stratification test. It is designed to inform two clinical
questions in the management of cutaneous melanoma: a patient’s
individual risk of sentinel lymph node (SLN) positivity and a
patient's personal risk of melanoma recurrence and/or metastasis.
By integrating tumor biology with clinical and pathologic factors
using a validated proprietary algorithm, DecisionDx-Melanoma is
designed to provide a comprehensive and clinically actionable
result to guide risk-aligned patient care. DecisionDx-Melanoma has
been shown to be associated with improved patient survival and has
been studied in more than 10,000 patient samples.
DecisionDx-Melanoma’s clinical value is supported by more than 40
peer-reviewed and published studies, providing confidence in
disease management plans that incorporate the test’s results.
Through March 31, 2023, DecisionDx-Melanoma has been ordered more
than 128,000 times for patients diagnosed with cutaneous
melanoma.
More information about the Castle’s tests can be found at
www.CastleTestInfo.com.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics
company improving health through innovative tests that guide
patient care. The Company aims to transform disease management by
keeping people first: patients, clinicians, employees and
investors.
Castle’s current portfolio consists of tests for skin cancers,
uveal melanoma, Barrett’s esophagus and mental health conditions.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to predict systemic therapy
response in patients with moderate-to-severe psoriasis, atopic
dermatitis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, Twitter and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq,
TissueCypher and IDgenetix are trademarks of Castle Biosciences,
Inc.
Forward-Looking Statements
This press release contains forward-looking statements 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: the potential of DecisionDx-SCC
test results to (i) improve prognostic accuracy to help optimize
and personalize treatment choices based on a patient's unique,
biological risk profile and (ii) help clinicians make informed
decisions regarding treatment and follow-up care (including closer
monitoring, more frequent imaging scans and the timely initiation
of adjuvant treatments to mitigate metastatic risk and improve
patient outcomes); and the potential of DecisionDx-Melanoma to
provide actionable information that can enable risk-aligned patient
care. The words “can,” “may” 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: subsequent study or trial results
and findings may contradict earlier study or trial results and
findings or may not support the results shown in these studies,
including with respect to the discussion of DecisionDx-SCC and
DecisionDx-Melanoma in this press release; actual application of
our tests may not provide the aforementioned benefits to patients;
and the risks set forth under the heading “Risk Factors” in our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023,
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.
- Arron ST, Wysong A, Hall MA, et al. Gene expression profiling
for metastatic risk in head and neck cutaneous squamous cell
carcinoma. Laryngoscope Investig Otolaryngol. 2022;7(1):135-144.
Published 2022 Jan 6. doi:10.1002/lio2.724
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version on businesswire.com: https://www.businesswire.com/news/home/20230707921511/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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