Recent AGA Clinical Practice Guideline Acknowledges That Individuals Who May Be at Increased Risk of Progression to Esophageal Cancer Might Be Identified Using Tissue-Based Biomarkers, Particularly Castle Biosciences’ TissueCypher® Test
24 Juni 2024 - 1:00PM
Business Wire
Castle’s TissueCypher test has been shown to
improve the risk stratification of patients with Barrett’s
esophagus (BE)1,2
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced that the latest American Gastroenterological Association
(AGA) clinical practice guideline recognized that not all patients
with non-dysplastic BE (NDBE) are at low risk of developing
esophageal cancer. The guideline acknowledges the role that
tissue-based biomarkers, including the tissue systems pathology
test (TissueCypher, also known as TSP-9), can play in identifying
high-risk NDBE patients who may benefit from endoscopic eradication
therapy (EET) to prevent disease progression.3
BE with high-risk features can often be effectively treated with
EET, such as ablation, which involves either burning or freezing
the abnormal esophageal lining. However, the ability to reliably
identify patients at increased risk of progression is crucial to
avoid missing patients who develop esophageal cancer as well as
limiting the over treatment of patients who have a lower risk of
progression. Studies have shown that TissueCypher is an independent
predictor of progression in patients with BE. Further, a pooled
analysis of clinical data from the Mayo Clinic showed that patients
with NDBE, traditionally deemed to be at a lower risk of advancing
to esophageal cancer, who receive TissueCypher high-risk scores,
are 18-times more likely to progress than patients with low-risk
scores.1
In the recently published AGA guideline, the expert panel of
authors acknowledge the role that tissue-based biomarkers
(particularly aberrant p53 or TissueCypher, alone or in combination
with clinical and endoscopic characteristics) can play in
stratifying the large pool of patients with NDBE to help identity
those at high risk of progression for consideration of treatment
with EET at an early, precancerous stage.
“We are pleased that the AGA has recognized that there is a
high-risk subset of NDBE patients who may benefit from early
intervention with EET and importantly, have acknowledged that
tissue-based biomarker testing can help identify these patients,”
said Emmanuel Gorospe, M.D., board-certified gastroenterologist and
GI medical director at Castle Biosciences. “This clinical need was
the driving factor behind the development of the TissueCypher test,
which provides a deeper look into a patient’s esophageal tissue to
identify molecular signs of progression that may lead to cancer
down the road.”
In 2022, the AGA’s “Clinical Practice Update on New Technology
and Innovation for Surveillance and Screening in Barrett’s
Esophagus” included a best practice advice statement that said
TissueCypher may be utilized for the risk-stratification of
patients with NDBE.4
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 13 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.
Learn more at www.CastleBiosciences.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,
Barrett’s esophagus, mental health conditions and uveal melanoma.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis 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, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM,
DecisionDx-PRAME and DecisionDx-UMSeq 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 continued ability
to (i) be an independent predictor of progression in patients with
BE and (ii) help stratify the large pool of patients with NDBE to
help identity those at high-risk of progression for consideration
of treatment with EET at an early, precancerous stage The words
“can,” “would” 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 TissueCypher test 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, 2023, our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2024 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.
- Iyer PG, Codipilly DC, Chandar AK, et al. Prediction of
progression in Barrett's esophagus using a tissue systems pathology
test: a pooled analysis of international multicenter studies. Clin
Gastroenterol Hepatol. 2022;20(12):2772-2779.e8.
doi:10.1016/j.cgh.2022.02.033
- Davison JM, Goldblum JR, Duits LC, et al. A tissue systems
pathology test outperforms the standard-of-care variables in
predicting progression in patients with Barrett's esophagus. Clin
Transl Gastroenterol. 2023;14(11):e00631. Published 2023 Nov 1.
doi:10.14309/ctg.0000000000000631
- Rubenstein JH, Sawas T, Wani S, et al. AGA clinical practice
guideline on endoscopic eradication therapy of Barrett’s esophagus
and related neoplasia. Gastroenterology. 2024;166(6):1020-1055.
doi: 10.1053/j.gastro.2024.03.019
- Muthusamy VR, Wani S, Gyawali CP, Komanduri S; CGIT Barrett’s
Esophagus Consensus Conference Participants. AGA clinical practice
update on new technology and innovation for surveillance and
screening in Barrett's esophagus: Expert Review. Clin Gastroenterol
Hepatol. 2022;20(12):2696-2706.e1. doi:
10.1016/j.cgh.2022.06.003
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240624724454/en/
Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com Media Contact: Allison
Marshall amarshall@castlebiosciences.com
Castle Biosciences (NASDAQ:CSTL)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Castle Biosciences (NASDAQ:CSTL)
Historical Stock Chart
Von Jun 2023 bis Jun 2024