New Data at DDW 2025 Further Demonstrates the TissueCypher® Test's Ability to Identify Patients at Increased Risk for Developing Esophageal Cancer
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Insights
Castle's TissueCypher test shows promise for detecting Barrett's esophagus patients at higher risk for esophageal cancer progression.
The data being presented at DDW 2025 highlights TissueCypher's potential to transform the management paradigm for Barrett's esophagus (BE). Two key poster presentations demonstrate the test's capabilities: one showing detection of missed neoplasia in non-dysplastic Barrett's esophagus, and another demonstrating risk stratification abilities for BE patients.
This technology addresses a critical challenge in BE management. The current standard involves periodic endoscopic surveillance with random biopsies—the "wait and see" approach referenced in the release. This methodology has significant limitations due to sampling error and the fact that most patients never progress to cancer despite undergoing lifelong surveillance.
TissueCypher employs tissue systems pathology, which provides more sophisticated analysis than traditional histology by integrating multiple biomarkers and morphological features. This potentially enables clinicians to identify which patients genuinely need aggressive surveillance versus those who might safely extend their surveillance intervals.
The involvement of prominent gastroenterologists from institutions like Johns Hopkins, UCLA, Northwestern, and University of Rochester indicates strong clinical interest. The educational sessions focused on moving "beyond the wait and see paradigm" suggest Castle is attempting to drive practice change, which typically requires substantial evidence and physician education.
While these presentations represent important steps in clinical validation, the release doesn't provide specific performance metrics such as sensitivity, specificity, or predictive values that would allow precise assessment of clinical utility. The technology appears promising, but broader adoption will ultimately depend on data strength, physician acceptance, and incorporation into clinical practice guidelines.
Castle Biosciences advances clinical validation of TissueCypher test through expert engagement, building scientific credibility for future growth.
Castle Biosciences (Nasdaq: CSTL) is executing a comprehensive medical education strategy for its TissueCypher Barrett's Esophagus test at the influential Digestive Disease Week 2025 conference. The company's approach includes two research posters, a dedicated product theater, and multiple educational sessions featuring key opinion leaders in gastroenterology.
This multi-faceted approach follows the classic specialty diagnostic commercialization playbook: build clinical evidence, engage thought leaders, present at major medical conferences, and work toward guideline inclusion. The collaboration with the American Society for Gastrointestinal Endoscopy (ASGE) is particularly significant, as specialty society support often precedes broader clinical adoption.
Barrett's esophagus represents a substantial market opportunity, affecting approximately 3-5% of adults in Western countries. Most patients are currently managed through regular endoscopic surveillance. A test that better stratifies risk could create significant value by directing resources toward high-risk patients while reducing unnecessary procedures for low-risk individuals.
The involvement of renowned specialists from major academic centers—including Johns Hopkins, UCLA, Northwestern, and University of Rochester—suggests the company is gaining traction with influential clinicians who can drive adoption. The frequency and prominence of educational activities indicate a coordinated push for clinical acceptance.
However, this press release focuses exclusively on upcoming data presentations rather than providing concrete business metrics or commercialization updates. Missing are details about reimbursement status, commercial penetration, or revenue projections that would enable assessment of near-term business impact. The company appears to be in the validation and education phase for this test, which represents important groundwork but typically precedes significant revenue generation in the specialty diagnostic market.
Additionally, an expert physician panel convened by EndoscopyNow will host a product theater on Sunday, May 4, at 2:45 p.m. Pacific Time, titled, “The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC”
FRIENDSWOOD, Texas, May 02, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share new data on its TissueCypher Barrett’s Esophagus test via two posters at the Digestive Disease Week® (DDW 2025) Annual Meeting, being held May 3-6 in San Diego. In addition to the product theater, Castle is collaborating with renowned gastrointestinal (GI) experts and the American Society for Gastrointestinal Endoscopy (ASGE) on several educational sessions highlighting the use of TissueCypher to improve the risk stratification and subsequent management of patients with Barrett’s esophagus (BE).
“The compelling new data being presented at DDW 2025 underpins the important role that TissueCypher can play in identifying patients with BE at higher risk for progression to esophageal cancer,” said Emmanuel Gorospe, M.D., MPH, board-certified gastroenterologist and GI medical director at Castle Biosciences. “By empowering clinicians to move beyond the traditional 'wait and see' approach, we're working to help enable more personalized surveillance and intervention strategies for BE patients that can potentially prevent cancer rather than simply trying to detect it early.”
The following posters will be presented at DDW 2025 (all times Pacific Time). Posters will be available on the DDW ePosters site and to conference attendees in the DDW meeting planner and mobile app after 12:01 a.m. on the day of the poster’s presentation.
1) Poster Su1466: The Tissue Systems Pathology Test Detected Presence of Missed Neoplasia in a Patient with Non-Dysplastic Barrett’s Esophagus
- Presenter and Lead Author: Philip Woodworth, M.D., Sky Ridge Heartburn and Reflux Treatment Center and Institute of Esophageal and Reflux Surgery
- Session Type: Poster Session
- Session Title: Pancreatic and Esophageal Diseases
- Session #: 7105
- Date & Time: Sunday, May 4, 12:30-1:30 p.m.
2) Poster Su1324: The Tissue Systems Pathology Test Provides Risk Stratification for Patients with Barrett’s Esophagus
- Presenter and Senior Author: Charles Randall, M.D., Gastroenterology Research of San Antonio and University of Texas Health Science Center at San Antonio
- Session Type: Poster Session
- Session Title: Barrett's Esophagus and Esophagogastric Junction Neoplasia - Biology and Fundamental
- Mechanisms, Epidemiology, Risk Factors, and Screening
- Session #: 7085
- Session Date & Time: Sunday, May 4, 12:30-1:30 p.m.
Visit Castle at DDW 2025
For more information on the TissueCypher test and the posters above, please visit Castle at booth 1017; a complete list of Castle’s activities at DDW 2025 can be found at https://info.castlebiosciences.com/ddw2025. Key events include the following:
Product Theater
- The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC
- Expert physician panel convened by EndoscopyNow includes:
- Vivek Kaul, M.D., professor of medicine at University of Rochester Medical Center
- Harshit Khara, M.D., associate professor of medicine and director of endoscopy at Geisinger Medical Center
- Jennifer Kolb, M.D., M.S., assistant professor of medicine, Vatche and Tamar Manoukian Division of Digestive Diseases at the David Geffen School of Medicine at UCLA and VA Greater Los Angeles Healthcare System
- Sri Komanduri, M.D., M.S., associate chief, division of gastroenterology and hepatology, and professor of medicine and surgery at Northwestern Feinberg School of Medicine
- Location: DDW Theater 1
- Date & Time: Sunday, May 4, 2:45-3:30 p.m.
- Expert physician panel convened by EndoscopyNow includes:
AGA Research Forum: Advances in Screening and Risk Stratification in Barrett's Esophagus
- Presentation title: Clinical utility of tissue systems pathology (TSP-9) risk stratification in patients with and without a family history of Barrett's esophagus and/or esophageal cancer
- Presenter: Marcia (Mimi) Canto, M.D., MHS, professor of medicine at The Johns Hopkins University School of Medicine
- Session #: 5270
- Date & Time: Tuesday, May 6, 10 a.m.
ASGE Theater Talks
1) Think BEyond the "Wait and See" paradigm for non-dysplastic Barrett's esophagus
- Presenter: Dan Lister, M.D., president and co-founder of the American Foregut Society and director of the Arkansas Heartburn Treatment Center
- Date & Time: Saturday, May 3, 11:30 a.m.-12 p.m.
2) The tissue systems pathology test detected presence of missed neoplasia in a patient with non-dysplastic Barrett's esophagus
- Presenter: Philip Woodworth, M.D., Sky Ridge Heartburn and Reflux Treatment Center and Institute of Esophageal and Reflux Surgery
- Date & Time: Monday, May 5, 12:15-12:45 p.m.
About Digestive Disease Week® (DDW)
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), the meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
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, 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 seeking biologic treatment. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, 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 ability to (i) play an important role in identifying BE patients at higher risk for progression to esophageal cancer, (ii) empower clinicians and (iii) enable more personalized surveillance and intervention 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 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
czuckero@castlebiosciences.com
Media Contact:
Allison Marshall
amarshall@castlebiosciences.com
Source: Castle Biosciences, Inc.
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