Castle Biosciences Shares New Data Demonstrating Ability of TissueCypher® Test Results to Inform Clinical Decision-Making in Patients with Non-Dysplastic Barrett’s Esophagus
02 10월 2023 - 8:00PM
Business Wire
Data shared via a poster presentation at the
recent American Foregut Society (AFS) Annual Meeting
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced new data demonstrating the significant clinical utility
of its TissueCypher® Barrett’s Esophagus test in guiding
risk-aligned upstaging of care for patients with non-dysplastic
Barrett’s esophagus (NDBE) at a higher risk of progression to
high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) than
indicated by their clinicopathologic risk factors.
The data was presented in a poster at the recent American
Foregut Society (AFS) Annual Meeting. The poster, titled “A Tissue
Systems Pathology Test Enables Risk-Aligned Management of Patients
with Non-Dysplastic Barrett’s Esophagus: Case Reports from a
Gastrointestinal Surgery Center,” can be viewed here.
"In the management of BE, there are several therapeutic
strategies to help prevent the development of esophageal cancer,”
said Daniel Tseng, M.D., F.A.C.S., surgeon at Northwest Minimally
Invasive Surgery Center in Portland, Oregon, and lead author of the
study. “These options include endoscopic eradication therapies
(EET) such as radiofrequency ablation (RFA) or cryoablation, as
well as anti-reflux surgery that can stop chronic injury to the
esophagus.
“The challenge arises in predicting which patients in the large
pool of those with NDBE are most likely to progress and could thus
benefit from these treatments early, when they are most effective.
These case studies support the use of TissueCypher to potentially
identify which NDBE patients are at a higher risk of disease
progression and should be managed accordingly.”
The overall population of patients with NDBE are considered to
be at low risk for progression based on their clinicopathologic
risk factors. However, the high incidence of NDBE indicates that at
least half of the patients who progress to HGD/EAC annually are
diagnosed as NDBE and can be missed by current
clinicopathologic-based risk stratification and therefore,
undertreated. The case study reinforced the ability of TissueCypher
to identify NDBE patients at high/intermediate risk for progression
to HGD/EAC. The patients in the case study had predicted 5-year
risk of progression to HGD/EAC that was similar (range 6-14%) to
the published estimates of progression in patients with confirmed
low-grade dysplasia (LGD) (8.5%), a pathologic diagnosis associated
with higher progression risk for which guidelines recommend EET,
such as RFA. Identification of NDBE patients with similar
progression risk to LGD enables physicians and their patients to
consider risk-aligned upstaging of care to prevent development of
EAC and improve their overall health outcomes.
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
identify which NDBE patients are at a higher risk of disease
progression and should be managed accordingly. The words “can,”
“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 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/20231002382456/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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