Castle’s presentations at AAD include the
latest findings from the Company’s ongoing collaboration with the
National Cancer Institute’s Surveillance, Epidemiology, and End
Results (SEER) Program Registries, providing new data from a study
of more than 5,000 patients confirming that testing with
DecisionDx®-Melanoma is associated with improved survival in
patients with cutaneous melanoma (CM)
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced that it will share data across its dermatologic portfolio
of gene expression profile (GEP) tests via oral and electronic
poster presentations at the 2024 AAD Annual Meeting, taking place
March 8-12 in San Diego.
“Our presentations at the 2024 AAD Annual Meeting add to the
growing body of evidence supporting the use of our tests in guiding
improved, personalized care for patients with skin cancers,” said
Robert Cook, Ph.D., senior vice president of research and
development at Castle Biosciences. “In collaboration with leading
dermatologists dedicated to advancing patient care, we are excited
to share our latest findings which highlight how our tests are
empowering both clinicians and patients with meaningful, clinically
actionable information that can refine risk and inform important
treatment decisions.”
Castle will present the following abstracts at AAD. Abstract
content will be available throughout the meeting in the online
viewing portal and at the on-site viewing stations, and will also
be published online in the Fall 2024 Journal of the American
Academy of Dermatology (JAAD) supplement.
DecisionDx®-Melanoma
- Oral Poster Presentation Title: 31-GEP testing is
associated with improved melanoma-specific survival relative to
untested patients: an analysis of patients <65 years old
- Presenter and Lead Author: Michael Tassavor, M.D., Skin
Cancer Center, Cincinnati
- Abstract Number: 51667
- Date: March 9, 2024
- Time: 4:50-4:55 p.m. Pacific Time
- Location: San Diego Convention Center (Upper Level,
Sails Pavilion, Poster Center 1)
Summary: For patients with CM, the median age at
diagnosis is 66 years old, suggesting that almost half of newly
diagnosed patients are younger than 65. In this large study of
unselected, clinically tested patients with CM who were under 65
(n=5,183), the DecisionDx-Melanoma (31-GEP) test identified
patients at higher risk of melanoma-specific death who may benefit
from more aggressive management, including imaging surveillance. In
the study, use of the DecisionDx-Melanoma test was associated with
improved melanoma-specific survival relative to untested patients.
This is clinically significant, as identifying high-risk patients
allows for earlier detection of recurrence, while the tumor burden
is lower, which has been shown to lead to better response to
therapy.
DecisionDx®-SCC
- Oral Poster Presentation Title: Consistent utilization
of the 40-gene expression profile (40-GEP) test in high-risk
cutaneous squamous cell carcinoma (cSCC) by clinicians according to
intended use indications
- Presenter and Lead Author: Jane Yoo, M.D., Icahn School
of Medicine at Mount Sinai, New York
- Abstract Number: 54153
- Date: March 9, 2024
- Time: 10:30-10:35 a.m. Pacific Time
- Location: San Diego Convention Center (Upper Level,
Sails Pavilion, Poster Center 2)
Summary: This study provides summary metrics regarding
DecisionDx-SCC (40-GEP) test results and patient risk factors for
tumor samples clinically tested in the first three years of the
test’s availability between September 2020 and August 2023
(n=16,930). The study data demonstrate that clinicians are
utilizing the DecisionDx-SCC test appropriately for patients with
high-risk cutaneous squamous cell carcinoma (SCC). These patients
are at a higher risk of poor outcomes compared to the general SCC
patient population, yet over 70% of patients received a
Decision-SCC Class 1 test result, indicating they are at a lower
biological risk for metastasis. Each DecisionDx-SCC Class result
was present in the various subgroupings of risk factors in the
study (patients with 1-2, 3-4 and more than 5 risk factors),
demonstrating that the test provides independent risk assessment
from clinicopathological presentation. These data support
incorporating the test’s results into clinical practice to improve
the accuracy of risk predictions to guide more personalized
treatment plans for patients.
MyPath® Melanoma
- ePoster Title: Enabling access to prognostic gene
expression profile (GEP) testing for invasive melanoma by
leveraging RNA-based testing in the diagnostic workflow
- Abstract Number: 52819
Summary: Reaching a definitive diagnosis of melanoma can
be challenging. Ancillary testing can provide clarity and a
definitive diagnosis for problematic lesions. The MyPath Melanoma
(23-GEP) diagnostic test returns accurate results quickly, with
approximately 80% of cases tested receiving an actionable result in
a median of four business days. Between March 1 and July 31, 2023,
approximately 60% of ambiguous lesions tested with MyPath received
a benign test result, potentially reducing overdiagnosis and
overtreatment for diagnostically challenging lesions. Lesions that
receive a malignant test result (approximately 20% of lesions
tested with MyPath in the five-month study timeframe) can be tested
with the DecisionDx-Melanoma risk stratification test, using the
same extracted tumor material when available, to inform
risk-aligned decisions about sentinel lymph node biopsy,
surveillance imaging and patient follow-up schedules. Approximately
80% of clinically tested lesions with a malignant MyPath result
have sufficient biopsy tumor content for DecisionDx-Melanoma
testing.
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 50
peer-reviewed and published studies, providing confidence in
disease management plans that incorporate the test’s results.
Through Dec. 31, 2023, DecisionDx-Melanoma has been ordered more
than 150,000 times for patients diagnosed with cutaneous
melanoma.
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 (higher) or Class 2B
(highest) 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 MyPath Melanoma
MyPath Melanoma is Castle’s gene expression profile test
designed to provide an accurate, objective result to aid
dermatopathologists and dermatologists in characterizing
difficult-to-diagnose melanocytic lesions. Of the approximately two
million suspicious pigmented lesions biopsied annually in the U.S.,
Castle estimates that approximately 300,000 of those cannot be
confidently classified as either benign or malignant through
traditional histopathology methods. For these cases, the treatment
plan can also be uncertain. Obtaining accurate, objective ancillary
testing can mean the difference between a path of overtreatment or
the risk of undertreatment. Interpreted in the context of other
clinical, laboratory and histopathologic information, MyPath
Melanoma is designed to reduce uncertainty and provide confidence
for dermatopathologists and help dermatologists deliver more
informed patient management plans.
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,
Barrett’s esophagus, mental health conditions and uveal melanoma.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq 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 ability of our tests to (i)
guide improved, personalized care for patients with skin cancers
and (ii) provide meaningful, clinically actionable information that
can refine risk and inform important treatment decisions. The words
“believe,” “can” 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 obtained in these studies, including with respect to the
discussion of our tests 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 Annual Report on Form 10-K for the year ended December 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240308635392/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com Media Contact: Allison
Marshall amarshall@castlebiosciences.com
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