Renowned eye cancer expert and study
investigator, Amy Schefler, M.D., will share early data from a
study to explore the potential for developing a complementary test
that would be tailored for individuals presenting with small,
suspicious lesions of uncertain malignant potential
Data will be presented at the 2023 American
Academy of Ophthalmology (AAO) Annual Meeting in San Francisco
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced new discovery data from an ongoing study exploring the
potential for developing a complementary, minimally invasive test
to evaluate small, suspicious lesions of uncertain malignant
potential in patients’ eyes.
“We are excited about the possibility of developing a new
minimally invasive test that would complement our current test
offerings for patients with uveal melanoma, including
DecisionDx®-UM, and reinforce our dedication to this important
patient population,” said Robert Cook, Ph.D., senior vice president
of research and development at Castle Biosciences. “This test would
potentially identify aggressive uveal melanomas when they are small
and more likely to be cured by prompt therapeutic
interventions.”
Bill Harbour, M.D., ophthalmologist, ocular oncologist, and
professor and chair of the department of ophthalmology at UT
Southwestern Medical Center, is also collaborating with Castle on
the study. Harbour is a leading innovator in the treatment and
study of uveal melanoma and the original developer of the
DecisionDx-UM test, which he licensed to Castle in 2009.
“For small ocular tumors suspected of being an early melanoma,
the current standard of care is a ‘watch and wait’ approach using
certain clinical characteristics to estimate the risk of
malignancy,” said Harbour. “Unfortunately, this approach is highly
subjective and can lead to both under- and over-treatment of
patients. Through this study, we are looking for aqueous biomarkers
that can easily and safely be obtained from the front part of the
eye during a quick office procedure that would signal a small tumor
may be malignant, which could prompt a definitive tumor biopsy and
appropriate intervention.”
Study data is being shared by Amy Schefler, M.D.,
board-certified ocular oncologist and vitreoretinal surgeon at
Retina Consultants of Texas, in an educational presentation this
morning at AAO. The presentation details are as follows:
Presentation title: Uveal Melanoma Liquid Biopsies: Are We
Going Anywhere? Section I: Loch Ness Monster’s Deep-Diving into
Liquid … Biopsies Session: PTH02 Date & Time: Friday, Nov. 3,
8:05-9:05 a.m. Pacific Time Location: WEST 2002
Castle expects to share additional updates in 2024 on the
ongoing exploratory study and potential development of a
complementary test. An excerpt from Schefler’s presentation
regarding the study can be viewed here.
About the Ongoing Exploratory Study Each year, up to
12,000 individuals present with a small suspicious uveal
melanocytic lesion of uncertain malignant potential in one of their
eyes; however, only about 2,000 of these patients will be diagnosed
with uveal melanoma and undergo definitive tumor treatment and
molecular prognostic biopsy. The current clinical standard of care
to determine which patients to treat involves a “watch and wait”
approach that consists of monitoring lesions for growth or
appearance of high-risk features that would indicate transformation
into a malignant melanoma. Castle’s ongoing exploratory study is
investigating the potential for developing a test that would
complement DecisionDx-UM and provide a minimally invasive solution
to identify lesions with aggressive biology earlier, enabling more
timely treatment with the goal of improving uveal melanoma patient
outcomes.
About DecisionDx®-UM DecisionDx-UM is Castle Biosciences’
15-gene expression profile (GEP) test that uses an individual
patient’s tumor biology to predict individual risk of metastasis in
patients with uveal melanoma. DecisionDx-UM is the standard of care
in the management of newly diagnosed uveal melanoma in the majority
of ocular oncology practices in the United States. Since 2009, the
American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual
for UM has specifically identified the GEP test as a prognostic
factor that is recommended for collection as a part of clinical
care. Further, the National Comprehensive Cancer Network (NCCN)
guidelines for uveal melanoma include the DecisionDx-UM test result
as a prognostic method for determining risk of metastasis and
recommended differential surveillance regimens based on a Class 1A,
1B and 2 result. DecisionDx-UM is the only prognostic test for
uveal melanoma that has been validated in prospective, multi-center
studies, and it has been shown to be a superior predictor of
metastasis compared to other prognostic factors, such as chromosome
3 status, mutational status, AJCC stage and cell type.
It is estimated that nearly 8 in 10 patients diagnosed with
uveal melanoma in the United States receive the DecisionDx-UM test
as part of their diagnostic workup.
More information about the test and disease 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 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, DecisionDx DiffDx-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:
(i) the potential for developing a complementary, minimally
invasive test to evaluate small, suspicious lesions of uncertain
malignant potential in patients’ eyes; (ii) the ability of such
test to identify aggressive uveal melanomas when they are small and
more likely to be cured by prompt therapeutic interventions; (iii)
the timing of additional test and study updates and (iv) the
ability of DecisionDx-UM to be a superior predictor of metastasis
compared to other prognostic factors, such as chromosome 3 status,
mutational status, AJCC stage and cell type. The words “can,”
“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:
subsequent study or trial results and findings may contradict
earlier study or trial results and findings or may not support the
results shown in this study, including with respect to the
discussion of DecisionDx-UM in this press release; actual
application of our DecisionDx-UM test 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, 2022, our Quarterly Report on Form 10-Q
for the three months ended September 30, 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/20231103336107/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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