Oral abstract will share data showing that
TissueCypher alone, compared to combining the test’s results with a
patient’s clinicopathologic risk factors, like age and pathology
diagnosis, is the strongest predictor of progression to esophageal
cancer
Poster will highlight ability of the test to
guide important patient management decisions, including upstaging
care for high-risk patients and supporting long-interval
surveillance for patients at low risk of progression
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, will
present new data supporting the ability of its TissueCypher
Barrett’s Esophagus test (TSP-9) to independently predict risk of
progression to esophageal cancer in patients with Barrett’s
esophagus (BE) at the American Foregut Society (AFS) 2024 Annual
Meeting, being held Sept. 25-29, 2024, in Denver.
“The large majority of patients in BE surveillance programs have
non-dysplastic BE (NDBE), and so they fall into what is considered
a low-risk category in which they are advised to see their doctor
every three to five years for an endoscopy,” said Rhonda F. Souza,
M.D., gastroenterologist, co-director of the Center for Esophageal
Research at Baylor Scott & White Research Institute and
co-director of the Center for Esophageal Diseases at Baylor
University Medical Center in Dallas. “However, many BE patients who
go on to develop esophageal cancer come from this allegedly
low-risk group. Our study shows that traditional clinicopathologic
variables are not helpful in predicting the risk of neoplastic
progression in patients with NDBE, and TSP-9 testing is far
superior in this regard. Rather than delaying surveillance for
years, we think that patients identified as high-risk by TSP-9
would benefit from more intensive surveillance or endoscopic
eradication therapy.”
“TissueCypher is the first test of its kind developed to offer a
solution for this clinical challenge,” said Rebecca
Critchley-Thorne, Ph.D., vice president of research and development
at Castle Biosciences. “The test continues to demonstrate its
substantial value in helping physicians tailor their treatment
plans for BE patients based on their likelihood of developing
esophageal cancer.”
Details regarding Castle’s presentations at AFS 2024 are
included below:
Oral presentation: TissueCypher is the strongest independent
predictor of progression in patients with Barrett’s
esophagus
Presenting Author: Rhonda F. Souza, M.D
Date & Time: Saturday, Sept. 28, 11:50 a.m.–12 p.m. Mountain
Time
Summary: The study aimed to evaluate whether routinely available
clinicopathologic factors used to risk stratify patients with BE,
including age, sex, BE segment length, hiatal hernia and original
pathology diagnosis (non-dysplastic Barrett’s esophagus (NDBE),
indefinite for dysplasia (IND) and low-grade dysplasia (LGD)),
could be combined with the patient’s TissueCypher risk score to
improve the accuracy of predicting progression to high grade
dysplasia (HGD) or esophageal cancer within five years. The study
showed that the addition of clinicopathologic factors did not
improve the predictive performance of the TissueCypher test; in
fact, TissueCypher, used alone, was the strongest predictor of
progression. In patients with NDBE, TissueCypher was the only
significant predictor of progression, supporting its significant
clinical utility in identifying high-risk patients in this large
population to help determine which may benefit from increased
surveillance or early interventions to prevent cancer.
Poster # 42: The tissue systems pathology test guides
risk-aligned management decisions in patients with non-dysplastic
Barrett's esophagus
Date & Time: Friday, Sept. 27, 12:45–12:50 p.m. Mountain
Time
Summary: This study evaluated the clinical utility of the
TissueCypher test in guiding risk-aligned clinical management
decisions for a series of consecutive patients with NDBE (n=14) at
an expert foregut surgery center. The patients received prospective
TissueCypher testing, and the ordering physician completed a
questionnaire describing their reason for ordering the test, their
management plan before and after receiving the test results, and
how the test results impacted their management decisions. The study
data showed a significant association between patients’
TissueCypher risk class and subsequent management decisions
(P=0.01099), with 86% of patients being managed in alignment with
their risk of progression to HGD or esophageal cancer according to
the test’s results. Use of TissueCypher test results led to
upstaged management in 21% of patients, such as the use of
endoscopic eradication therapy to help prevent progression to
esophageal cancer. The test also supported long-interval
surveillance (3-5 years), consistent with guideline
recommendations, in 90% of low-risk patients. These data highlight
the clinical value of the TissueCypher test in guiding risk-aligned
management decisions for patients with NDBE and increasing
physician confidence in those decisions.
About TissueCypher® Barrett’s Esophagus Test
The TissueCypher Barrett’s Esophagus test is Castle’s precision
medicine test designed to predict future development of high-grade
dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s
esophagus (BE). The TissueCypher Barrett’s Esophagus test is
indicated for use in patients with endoscopic biopsy confirmed BE
that is graded non-dysplastic (NDBE), indefinite for dysplasia
(IND) or low-grade dysplasia (LGD); its clinical performance has
been supported by 14 peer-reviewed publications of BE progressor
patients with leading clinical centers around the world. The test
received Advanced Diagnostic Laboratory Test (ADLT) status from the
Centers for Medicare & Medicaid Services (CMS) in March 2022.
Learn more at www.CastleBiosciences.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,
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, 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: (i) Castle’s ability to advance
care for patients with BE; (ii) the ability of the TissueCypher
test to be the strongest predictor of risk of progression to
esophageal cancer in patients with BE based on published studies;
and (iii) the ability of the TissueCypher test to guide important
patient management decisions, including upstaging care for
high-risk patients and supporting long-interval surveillance for
patients at low risk of progression. 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 TissueCypher in this press release; actual
application of our TissueCypher 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, 2023, our Quarterly Report on Form 10-Q
for the quarter ended June 30, 2024 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/20240923959743/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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