TissueCypher® Provides Clinically-Impactful Risk Stratification in Patients with Barrett’s Esophagus
08 Setembro 2023 - 5:30PM
Business Wire
The TissueCypher Barrett’s Esophagus test can
identify patients at a higher or lower risk of developing
esophageal cancer than indicated by pathologic diagnoses and
clinical risk factors to guide escalated or de-escalated patient
management
Data to be highlighted at the 19th ISDE World
Congress for Esophageal Diseases
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, will share
new data demonstrating the risk stratification performance of its
TissueCypher® test in an oral presentation during the Presidential
Plenary Session of the 19th ISDE World Congress for Esophageal
Diseases, being held Sept. 8-10 in Toronto, Canada.
“Current clinical practice guidelines recommend intervention
strategies such as close surveillance and endoscopic eradication
therapy for Barrett’s patients with low-grade dysplasia due to
their increased risk of developing esophageal adenocarcinoma,” said
David L. Diehl, M.D., director of the advanced endoscopy fellowship
at Geisinger Medical Center and clinical professor of medicine and
pathology at the Geisinger Commonwealth School of Medicine. “Based
on the data in this study, it is reasonable to conclude that
Barrett’s patients with intermediate or high-risk TissueCypher
results, regardless of their pathologic diagnosis or clinical risk
factors, may benefit from similar, escalated treatment to detect
progression early when it is most treatable.”
Details regarding Castle’s presentation are as follows:
PPL01.2 The Tissue Systems Pathology-9 Test Provides
Clinically-Impactful Risk Stratification in Patients with Barrett’s
Esophagus: Clinical Experience in a Multicenter Cohort
Presenting Author: Michael Yodice, M.D., Department of
Gastroenterology and Hepatology at Geisinger Medical Center Paper
#: 303 Session: Presidential Plenary Session Date & Time:
Saturday, Sept. 9, from 9:15-10:30 a.m. Eastern time Location:
Osgoode Ballroom East
In the study, TissueCypher test results ordered by 776
physicians from January 2022 to March 2023 for 4,073 patients with
Barrett’s esophagus (BE) were analyzed. Most patients were male
(61.8%), under surveillance in a community-based practice (94.9%)
and had a diagnosis of non-dysplastic Barrett’s esophagus (NDBE)
(95.1%), which is representative of the general BE patient
population. Patients with NDBE are considered to be at low risk for
progression based on their clinical risk factors. However,
TissueCypher identified a subset of patients with NDBE who received
high/intermediate test scores and had a 5-year probability of
progression to high-grade dysplasia (HGD)/esophageal adenocarcinoma
(EAC) similar to patients with low-grade dysplasia (LGD) (9.1% vs.
9.4%).
TissueCypher also identified low-risk subsets of BE patients
with diagnoses of indefinite for dysplasia (IND) and LGD who had
similar risk of progression to patients with NDBE, and whose care
could be de-escalated and safely managed using a surveillance-only
approach.
These data demonstrate that TissueCypher provided impactful risk
stratification, independent of clinicopathologic risk factors, to
enable risk-aligned management of BE patients. This included
objective information to support surveillance-only management for
patients with a low risk of progression and escalated
surveillance/treatment for patients at high risk of progression.
Further, the data suggest that broad use of TissueCypher test
results could increase the early detection of NDBE patients at a
higher risk of progression – patients whose progression may be
missed by the current standard of care surveillance recommendations
– who may benefit from escalated care to prevent progression to
EAC.
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 12 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)
identify patients at a higher or lower risk of developing EAC than
indicated by pathologic diagnoses and clinical risk factors to
guide escalated or de-escalated patient management; (ii) provide
certain benefits to BE patients with intermediate or high-risk
TissueCypher results, regardless of their pathologic diagnosis or
clinical risk factors; and (iii) increase the early detection of
NDBE patients at a higher risk of progression who may benefit from
escalated care to prevent progression to EAC. 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, 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/20230908916833/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com Media Contact: Allison
Marshall amarshall@castlebiosciences.com
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