New Publication Highlights the Ability of the TissueCypher® Barrett’s Esophagus Test to Improve and Standardize the Clinical Management of Low-Grade Dysplasia in Patients with Barrett’s Esophagus
07 Agosto 2023 - 8:00AM
Business Wire
In the study, management decisions were
simulated to determine the most likely care plan with or without
use of the TissueCypher test for guidance
Study data shows TissueCypher test results
significantly improved the likelihood of appropriate management and
the consistency of management decisions
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced a new study published in The American Journal of
Gastroenterology showing how use of TissueCypher® Barrett’s
Esophagus test results can significantly improve management
decisions for Barrett’s esophagus (BE) patients with low-grade
dysplasia (LGD) to improve health outcomes. The full study is
available here.
“A significant challenge in the clinical management of Barrett’s
esophagus is the inconsistency in diagnoses, and thus patient
management, when relying solely on pathology review of biopsied
tissue,” said Jacques Bergman, M.D., Ph.D., study author, leading
BE expert and Professor of Gastrointestinal Endoscopy at the
University of Amsterdam and the Amsterdam University Medical
Centers, the Netherlands. “As demonstrated in this study,
TissueCypher test results offer a tool that may alleviate this
challenge by providing objective and actionable risk-stratification
that can improve patient care decisions, including the upstaging of
care for high-risk patients and the downstaging of care for
patients who are at low-risk for progression to more advanced
dysplasia or esophageal cancer.”
The study involved a cohort of 154 real patients with
community-based LGD and known progression/non-progression outcomes
who were followed prospectively as part of the Surveillance versus
Radiofrequency Ablation (SURF) trial. Management decision
simulations were performed to determine the most likely care plan
with or without use of TissueCypher, where each patient’s specimens
were reviewed by 30 pathologists, leading to confirmation of
dysplasia or downstaging to non-dysplastic Barrett’s esophagus
(NDBE) or indefinite for dysplasia (IND). The study results showed
the following:
- Using TissueCypher test results to guide patient management
decisions, in conjunction with the standard of care (SOC),
significantly increased the likelihood of patients receiving
appropriate management per their known outcome.
- The median of patients receiving appropriate management in each
simulation increased from 80.8% with SOC alone to 100% when
TissueCypher test results were used to guide management decisions
(p=0.0007).
- Use of TissueCypher test results significantly improved the
consistency of management decisions for patients by reducing the
impact of variable pathology review (p<0.0001).
- The percentage of patients with 100% of simulations resulting
in appropriate management significantly increased from 9.1% with
SOC pathology review to 58.4% when TissueCypher test results were
used in conjunction with pathology, and further increased to 77.3%
when only TissueCypher test results were used to guide management
decisions.
Overall, the study results suggest that TissueCypher may be used
to standardize the management of BE patients with NDBE, IND and
LGD. Broad use of TissueCypher test results should improve BE
health outcomes by increasing the early detection of patients at a
high risk of progression who can receive therapeutic interventions
or close surveillance, both of which are effective strategies to
reduce the incidence and mortality of esophageal adenocarcinoma.
Use of the TissueCypher test may also improve health outcomes by
identifying patients at a low risk of progression who can avoid
unnecessary therapy and be managed using surveillance alone.
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). TissueCypher is indicated for use in patients with
endoscopic biopsy confirmed BE that is graded non-dysplastic (ND),
indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its
clinical performance has been supported by ten peer-reviewed
publications of BE progressor patients with leading clinical
centers around the world. The TissueCypher Barrett’s Esophagus
Assay is a proprietary Laboratory Developed Test with its own
unique CPT PLA code (0108U). Additionally, the test received
Advanced Diagnostic Laboratory Test (ADLT) status from the Centers
for Medicare & Medicaid Services (CMS) in March 2022 and was
recognized by the American Gastroenterological Association (AGA) in
their 2022 Clinical Practice Update as a tool that may be used to
risk-stratify patients with NDBE.
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, Twitter 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: the potential of TissueCypher
test results to (i) significantly improve management decisions for
BE patients with LGD to improve health outcomes; (ii) serve as a
tool that may provide objective and actionable risk-stratification
that can improve patient care decisions; (iii) standardize the
management of BE patients with NDBE, IND and LGD; (iv) improve BE
health outcomes by increasing the early detection of patients at a
high risk of progression who can receive therapeutic interventions
or close surveillance; and (v) improve health outcomes by
identifying patients at a low risk of progression who can avoid
unnecessary therapy and be managed using surveillance alone. The
words “can,” “may,” “potential” 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 tests may not provide the
aforementioned benefits to patients; and the risks set forth under
the heading “Risk Factors” in our Quarterly Report on Form 10-Q for
the quarter 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/20230807626053/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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