The study, published in Gastroenterology, shows
TissueCypher can increase the detection of Barrett’s esophagus (BE)
patients with an initial diagnosis of low-grade dysplasia (LGD) who
will progress to high-grade dysplasia (HGD) or esophageal
adenocarcinoma (EAC)
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of data demonstrating that the
TissueCypher® Barrett’s Esophagus test outperformed standard of
care pathology review in predicting malignant progression to HGD
and EAC in BE patients with an initial diagnosis of LGD. The study
findings are available online in Gastroenterology.1
“The significant variability in pathology diagnoses of Barrett’s
esophagus is compounded by the challenges of effectively predicting
which patients among the hundreds of thousands who are diagnosed
each year are most likely to progress to advanced forms of the
disease and/or cancer,” 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. “TissueCypher has the
ability to change this paradigm. Using Artificial Intelligence, the
test looks deeper into in a patient’s disease than possible through
traditional pathology review, providing objective information
regarding a patient’s risk of progressing to esophageal cancer that
can ensure early access to effective and possibly curative
treatments.”
The study evaluated the risk-stratification performance of
TissueCypher in 154 BE patients with an initial community-based
diagnosis of LGD with known progression/non-progression outcomes
who were prospectively followed as part of the Surveillance versus
Radiofrequency Ablation (SURF) trial. The study aimed to compare
the test’s performance against an international panel of 14 expert
and 16 community-based, generalist pathologists from five
countries.
In the study, the TissueCypher test demonstrated higher
sensitivity in detecting patients who progressed to HGD/EAC when
compared to the panel of pathologists (71% vs. mean 63%, range
33-88% across 30 pathologists; p=0.01186). Importantly,
TissueCypher identified 43% of the progressors downstaged to NDBE
by the pathologists (and 54.4% of the progressors downstaged to
NDBE/IND) and could thus be missed by standard of care due to the
variability in pathologist diagnoses. Use of the TissueCypher test
in combination with pathology review identified 80.4% of patients
who progressed, indicating that the test can increase the early
detection of progressors when used with pathology. Additionally,
patients with NDBE who received TissueCypher high-risk scores
progressed to HGD/EAC at a rate of 21.4% within five years, which
is higher than the published rate of progression in patients with
expert pathologist-confirmed LGD (8.5% within 5 years). This
high-risk subset of BE patients who may be missed by standard of
care pathology review can be detected early by the TissueCypher
test, enabling intervention with endoscopic eradication therapy to
prevent development of EAC, or close surveillance to detect
dysplasia and EAC at early, treatable stages.
Overall, the study demonstrated that TissueCypher can accurately
predict progression to HGD or EAC in BE patients who are initially
diagnosed with LGD in a community setting. Further, TissueCypher
test results can provide an objective solution to variable
pathology review, allowing physicians to make more informed
management decisions for their patients, which may include
upstaging care for patients at high risk for progression and
reducing unnecessary interventions in low-risk patients.
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.
More information about the test and disease can be found at
www.CastleTestInfo.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,
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)
increase the accurate detection of BE patients with initial
community-based diagnosis of LGD who will progress to HGD or EAC;
(ii) change the standard of care paradigm and use Artificial
Intelligence to provide objective information regarding a patient’s
risk of progressing to EAC that can ensure early access to
effective and possibly curative treatments; (iii) increase the
early detection of progressors when used with pathology; (iv)
detect a high-risk subset of BE patients and enable intervention
with endoscopic eradication therapy to prevent development of EAC,
or close surveillance to detect dysplasia and EAC at early,
treatable stages; and (v) provide an objective solution to variable
pathology review, allowing physicians to make more informed
management decisions for their patients, which may include
upstaging care for patients at high risk for progression and
reducing unnecessary interventions in low-risk patients. The words
“can,” “could,” “may,” “will” 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.
1. Khoshiwal AM, Frei NF, Pouw RE, et al. A tissue systems
pathology test outperforms pathology review in risk stratifying
patients with low-grade dysplasia. Gastroenterology. 2023. doi:
https://doi.org/10.1053/j.gastro.2023.07.029
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version on businesswire.com: https://www.businesswire.com/news/home/20230914345301/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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