Castle Biosciences will present new TissueCypher test data at the AFS Annual Meeting, highlighting personalized risk stratification for Barrett's esophagus patients.
Quiver AI Summary
Castle Biosciences, Inc. has announced that new data on its TissueCypher Barrett’s Esophagus test will be presented at the American Foregut Society's 2025 Annual Meeting in Dallas. The findings, led by Dr. Caitlin C. Houghton, highlight the test's capability to provide personalized risk stratification for patients with Barrett’s esophagus, showing that it can identify individuals at higher risk for cancer progression who might be overlooked by standard pathology. In a study involving 85 patients diagnosed with non-dysplastic Barrett's esophagus, 15% were classified as intermediate- or high-risk despite guidelines suggesting low risk, indicating that TissueCypher offers valuable insights for tailored patient care. The test aims to enhance management strategies, potentially leading to earlier interventions to prevent the development of esophageal cancer.
Potential Positives
- Castle Biosciences will present new data on its TissueCypher Barrett’s Esophagus test at a prestigious medical meeting, the American Foregut Society's 2025 Annual Meeting, enhancing visibility and credibility within the medical community.
- The study shows that TissueCypher provides personalized risk stratification for patients with Barrett’s esophagus, indicating a significant advancement in precision medicine that can improve patient outcomes and potentially reduce esophageal cancer incidence.
- TissueCypher identified 15% of patients who were at higher risk for disease progression than previously assessed, which underscores the test's clinically meaningful impact and the potential for more effective treatment strategies.
- The test's Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) reflects its recognized importance in guiding patient care, potentially leading to increased adoption and utilization in clinical settings.
Potential Negatives
- The study presented indicates that a significant minority (15%) of patients with non-dysplastic Barrett’s Esophagus were classified as intermediate- or high-risk, potentially highlighting the limitations of existing standard pathology methods and raising questions about the reliability of the current diagnostic approach.
- The mention of increasing incidence rates of esophageal cancer suggests potential inadequacies in the company’s previous offerings or the medical community's overall management strategies, which may cast doubt on its effectiveness in addressing patient needs.
- The forward-looking statements include significant risks and uncertainties, indicating that outcomes related to the TissueCypher test may not be as beneficial or predictive as suggested, which could impact investor confidence.
FAQ
What is the TissueCypher Barrett’s Esophagus test?
The TissueCypher Barrett’s Esophagus test predicts the risk of high-grade dysplasia and esophageal cancer in patients with Barrett’s esophagus.
When will the new data on TissueCypher be presented?
The new data will be presented at the American Foregut Society's Annual Meeting from September 11-13, 2025.
Who is presenting the findings on TissueCypher?
The findings will be presented by Caitlin C. Houghton, M.D., a board-certified foregut surgeon.
What makes TissueCypher different from standard pathology?
TissueCypher provides personalized risk stratification, identifying patients at higher risk for disease progression who may be overlooked by standard pathology.
How does TissueCypher support patient care?
TissueCypher helps tailor surveillance and treatment strategies for Barrett’s esophagus patients based on their individual risk levels, potentially preventing cancer.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
FRIENDSWOOD, Texas, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that new data demonstrating the personalized risk stratification provided by its TissueCypher Barrett’s Esophagus test will be shared via a podium presentation at the American Foregut Society's (AFS) 2025 Annual Meeting, taking place Sept. 11-13, 2025, in Dallas.
"The findings being presented at AFS underscore the importance of moving beyond standard pathology when assessing progression risk in patients with Barrett’s esophagus,” said lead study author Caitlin C. Houghton, M.D., board-certified foregut surgeon at Keck Medicine of USC in Los Angeles. “TissueCypher provides an added level of precision that is designed to reveal high-risk patients who might otherwise be overlooked, potentially enabling personalized surveillance and treatment strategies aimed at reducing their chances of developing esophageal cancer."
Details regarding the podium presentation are included below:
Title: Patients With Non-Dysplastic Barrett’s Esophagus Received Individualized Risk Stratification With the Tissue Systems Pathology Test
- Presenter and Lead Author: Caitlin C. Houghton, M.D.
- Session: AFS Podium Presentations
- Date & Time: Saturday, September 13, 10-10:10 a.m. Central time
- Location: Tate B
For patients with Barrett’s esophagus (BE), regular endoscopic surveillance is intended to catch signs of disease progression early, when endoscopic eradication therapy (EET) can be most effective in preventing advancement to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Many doctors rely on a patient’s clinical history and pathology results to estimate cancer risk and set intervals for follow-up endoscopic surveillance. These population-based risk estimates have done little to slow the rising incidence of esophageal cancer. This underscores the need for more precise tools, like TissueCypher, that can help identify a patient’s individual risk of progressing to cancer and guide care that is better aligned to that risk.
This study evaluated TissueCypher’s ability to stratify risk in 85 patients diagnosed with NDBE who received test results from four surgical practices. Patients with NDBE are generally considered to have the lowest risk of cancer progression, and current guidelines recommend surveillance every three to five years. However, while 85% of patients in the study received low-risk TissueCypher results, 15% were classified as intermediate- or high-risk by the TissueCypher test, indicating a significantly higher likelihood of progressing to HGD or EAC than their pathology results suggested. Patients with intermediate-risk scores had a median five-year progression probability of 9%, and those with high-risk scores had a 16% probability. Both groups exceeded the 8.5% five-year risk of progression associated with expert-confirmed LGD based on population estimates, which is the threshold at which guidelines recommend escalating to EET or more frequent surveillance every six to twelve months.
These findings show that TissueCypher can deliver clinically meaningful risk insights that can help physicians better tailor care for patients with BE. Notably, patients in the study with intermediate- and high-risk scores had similar or greater predicted progression risk than patients diagnosed with LGD, despite having a NDBE diagnosis. By identifying low-risk patients whose care can follow guideline-based surveillance intervals and intermediate- and high-risk patients who may benefit from earlier intervention, TissueCypher can potentially support more precise, risk-aligned management aimed at preventing disease progression.
For more information on the TissueCypher test, please visit Castle at exhibit #22.
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 16 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, Barrett’s esophagus and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and 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 seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn , Facebook , X and Instagram .
DecisionDx-Melanoma, DecisionDx-CM Seq , i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq 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 ability to play an important role in identifying BE patients at higher risk for progression to esophageal cancer, and enable more personalized surveillance and treatment strategies for BE patients that help prevent cancer. The words “believe,” “can” 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 obtained in these studies, including with respect to the discussion of our tests 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, 2024, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC, 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.
Investor Contact:
Camilla Zuckero
[email protected]
Media Contact:
Allison Marshall
[email protected]
Source: Castle Biosciences, Inc.
