Two posters highlight ability of the
TissueCypher test to identify higher- and lower-risk subsets of
patients with Barrett’s esophagus than indicated by their
clinicopathologic factors to guide risk-aligned patient care
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, will
highlight the impactful risk stratification provided by its
TissueCypher® test in patients with Barrett’s esophagus (BE)
through two posters at the 2023 American College of
Gastroenterology (ACG 2023) Annual Scientific Meeting, taking place
Oct. 20-25, in Vancouver, Canada.
“The large majority of patients undergoing surveillance for BE
in the U.S. have a pathology diagnosis of non-dysplastic Barrett’s
esophagus (NDBE), which carries the lowest risk of developing
esophageal adenocarcinoma (EAC) according to the patient’s
clinicopathologic factors, such as their age, sex and BE segment
length,” said David L. Diehl, M.D., board-certified and
fellowship-trained gastroenterologist, director of advanced
endoscopy fellowship at Geisinger Medical Center, adjunct associate
professor of medicine at New York University School of Medicine,
clinical professor of medicine at Geisinger Commonwealth School of
Medicine and senior author of Castle’s posters at ACG 2023.
“However, we find that at least half of the patients who progress
to EAC come from this “low-risk” population, which tells us that
there is a critical need to improve our risk-stratification of
these patients. The TissueCypher test can help by providing
objective risk stratification that can identity patients who are
likely to progress to EAC and may benefit from escalated management
strategies to potentially help prevent a future cancer
diagnosis.”
Castle’s posters will be available for viewing today, Tuesday,
Oct. 24, from 10:30 a.m.-4 p.m., with presenting authors available
to answer questions from 1-2:15 p.m., all times Pacific.
P3265: The Tissue Systems Pathology Test Objectively
Risk-Stratifies Patients with Barrett’s Esophagus: A Multicenter
U.S. Clinical Experience Study (view poster here)
In the multi-center study, TissueCypher provided impactful risk
stratification within all BE patient subsets (n=5,350) according to
patients’ risk of progressing to high-grade dysplasia (HGD)/EAC
within five years. In patients with lower-risk clinicopathologic
factors (females with a pathology diagnosis of NDBE), TissueCypher
identified intermediate/high-risk patients who were predicted to
progress at a higher rate than patients with low-grade dysplasia
(LGD) and may benefit from escalated care to potentially prevent
HGD/EAC. In patients with higher-risk clinicopathologic factors
(males with a pathology diagnosis of indefinite for dysplasia (IND)
or LGD), TissueCypher identified low-risk patients with predicted
progression rates similar to patients with NDBE. This finding
indicates that there are low-risk patients with IND who may be
effectively managed by long interval surveillance, and low-risk
patients with LGD who may be effectively managed by short interval
surveillance instead of endoscopic eradication therapy, as
suggested by guidelines.
Overall, the data show the risk stratification provided by the
TissueCypher test can aid physicians and patients in making
risk-aligned patient management decisions, such as escalated or
de-escalated care, which may lead to improved health outcomes.
P3264: The Tissue Systems Pathology Test Predicts Risk of
Progression in Medicare-Eligible Patients with Barrett’s
Esophagus (view poster here)
The study evaluated the risk-stratification performance of the
TissueCypher test in two cohorts of Medicare-eligible patients (65
years of age or older) with BE: a clinical outcomes cohort (n=290)
for which patients’ outcomes were known, and a clinical use cohort
from TissueCypher orders over the last seven years (n=2,828).
TissueCypher provided significant risk-stratification in both
cohorts. In the clinical outcomes cohort, the test demonstrated
significantly higher sensitivity in detecting patients who
progressed to HGD/EAC (64.0%; 95% CI 53.3-74.7) when compared to
real-world or expert pathology diagnoses of LGD (38.7%; 95% CI
28.0-49.3 and 22.6%; 95% CI 13.3-33.3, respectively; p<0.05).
Additionally, consistent with the study reported above and several
previously published studies, TissueCypher identified patients at a
higher or lower risk of progression to HGD/EAC than indicated by
their pathologic diagnosis to guide more informed and risk-aligned
patient care.
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 15 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.
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, X 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: TissueCypher’s potential to (i)
provide objective risk stratification that can identity patients
who are likely to progress to EAC, (ii) aid physicians and patients
in making risk-aligned patient management decisions, such as
escalated or de-escalated care; and the continued ability of
TissueCypher to predict future development of HGD and/or esophageal
cancer in patients with BE. The words “can,” “could,” “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, including with respect
to the discussion of the TissueCypher® Barrett’s Esophagus test 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, 2022, our Quarterly Report on Form
10-Q for the three months ended June 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/20231024647223/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com Media Contact: Allison
Marshall amarshall@castlebiosciences.com
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