Castle Biosciences will present new data at Digestive Disease Week (DDW) 2025 demonstrating how its TissueCypher Barrett's Esophagus test can identify patients at increased risk for developing esophageal cancer. The company will showcase these findings through two poster presentations at the conference being held May 3-6 in San Diego.
The TissueCypher test represents a significant advancement in the management of Barrett's esophagus (BE), a condition that can progress to esophageal adenocarcinoma (EAC) if left untreated. According to Emmanuel Gorospe, M.D., MPH, board-certified gastroenterologist and GI medical director at Castle Biosciences, the test enables clinicians to move beyond traditional approaches.
"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 Gorospe. "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."
Key Research Findings
Two posters highlighting the clinical utility of TissueCypher will be presented on Sunday, May 4:
The first poster (Su1466), presented by Philip Woodworth, M.D., from the Sky Ridge Heartburn and Reflux Treatment Center, demonstrates how the tissue systems pathology test detected the presence of missed neoplasia in a patient with non-dysplastic Barrett's esophagus. This finding suggests the test may help identify patients who require more intensive surveillance despite having apparently low-risk histology.
The second poster (Su1324), presented by Charles Randall, M.D., from Gastroenterology Research of San Antonio, focuses on how the test provides effective risk stratification for patients with Barrett's esophagus. This capability could help clinicians tailor surveillance intervals and intervention strategies based on individual risk profiles.
Clinical Impact on Barrett's Esophagus Management
Barrett's esophagus affects approximately 5.6% of the U.S. population, with patients having a 30-40 times higher risk of developing esophageal adenocarcinoma compared to the general population. Traditional management relies heavily on endoscopic surveillance at standardized intervals based primarily on dysplasia grade.
The TissueCypher test aims to transform this approach by providing objective risk assessment that can identify high-risk patients who might benefit from more frequent surveillance or earlier intervention, even when dysplasia is not histologically evident.
The test analyzes tissue samples using advanced image analysis and machine learning algorithms to evaluate multiple biomarkers associated with progression to high-grade dysplasia or esophageal cancer. Its clinical performance has been validated through 16 peer-reviewed publications involving BE progressor patients at leading clinical centers worldwide.
Educational Sessions at DDW 2025
In addition to the poster presentations, Castle Biosciences is collaborating with gastrointestinal experts and the American Society for Gastrointestinal Endoscopy (ASGE) on several educational sessions at DDW 2025.
A product theater titled "The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC" will feature an expert physician panel convened by EndoscopyNow on Sunday, May 4. The panel includes prominent gastroenterologists from major medical institutions:
- 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 at UCLA
- Sri Komanduri, M.D., M.S., associate chief of gastroenterology and hepatology at Northwestern Feinberg School of Medicine
Other notable presentations include an AGA Research Forum on advances in screening and risk stratification in Barrett's esophagus, featuring Marcia (Mimi) Canto, M.D., MHS, from Johns Hopkins University School of Medicine, and ASGE Theater Talks encouraging clinicians to move beyond the "wait and see" paradigm for non-dysplastic Barrett's esophagus.
Regulatory and Commercial Status
The TissueCypher Barrett's Esophagus test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022, an important designation that recognizes innovative laboratory tests that provide novel clinical information that cannot be obtained from any other test.
The test is indicated for use in patients with endoscopic biopsy-confirmed BE that is graded non-dysplastic, indefinite for dysplasia, or low-grade dysplasia. This encompasses the majority of BE patients who traditionally would be placed on routine surveillance protocols.
Future Directions
Castle Biosciences continues to expand its portfolio of precision diagnostic tests, which currently includes tests for skin cancers, Barrett's esophagus, mental health conditions, and uveal melanoma. The company is also developing tests for other conditions with high clinical need, including a test to guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis.
For gastroenterologists and patients with Barrett's esophagus, the TissueCypher test represents a shift toward more personalized medicine that could potentially reduce the incidence of esophageal adenocarcinoma through earlier identification of high-risk individuals and timely intervention.
"We're seeing a paradigm shift in how Barrett's esophagus is managed," noted Gorospe. "Rather than waiting for cancer to develop, we now have tools that can help us identify which patients need more aggressive monitoring and potentially earlier intervention, potentially saving lives through prevention rather than just early detection."
