Friendswood, Texas, U.S., September 28, 2026
Castle Biosciences has announced new clinical evidence demonstrating how its TissueCypher® Barrett’s Esophagus Test can influence management decisions for patients with non-dysplastic Barrett’s esophagus (NDBE). Published in Foregut: The Journal of the American Foregut Society, the case-series study evaluated patients receiving care at Keck Medical Center of the University of Southern California (USC) and found that clinicians changed their management recommendations in 90% of patients after reviewing TissueCypher results. The findings highlight the potential role of molecular risk stratification in helping clinicians distinguish patients who may require more intensive surveillance or treatment from those who may be appropriate for less intensive management.
TissueCypher Identifies Different Risk Levels
Barrett’s esophagus is a precancerous condition associated with an increased risk of developing high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Patients with NDBE generally have no detected dysplasia, but their individual risk of progression can vary. The Castle study evaluated 30 patients with NDBE to examine whether TissueCypher could provide additional information to support risk-aligned clinical decisions. The test classified 17% of patients as intermediate or high risk for progression to HGD or EAC within five years, while 83% were classified as low risk. The findings illustrate how molecular information can differentiate risk among patients who initially share the same non-dysplastic diagnosis. According to Castle, clinicians subsequently changed management recommendations for 90% of the patients, including both escalation and de-escalation of care based on the test results.
Study Supports Risk-Aligned Management
Among patients receiving intermediate- or high-risk TissueCypher results, clinicians escalated management in every case. The study reported that four patients underwent endoscopic eradication therapy, while another patient received shorter-interval surveillance. These decisions reflected the higher progression-risk classifications generated by the test. The study also reported changes in management for patients classified as lower risk. Among those receiving low-risk TissueCypher results, 84% had their management de-escalated, including recommendations for longer surveillance intervals or removal of previously planned endoscopic eradication therapy. Overall, Castle reported that TissueCypher results either changed management recommendations or increased physician confidence in existing plans for 97% of patients. These findings are particularly relevant because most patients undergoing surveillance for Barrett’s esophagus have non-dysplastic disease. Traditional clinical and pathological assessments may not fully distinguish every patient’s future progression risk, creating interest in additional molecular tools that could complement existing clinical evaluation. The new case series provides real-world evidence from an expert gastrointestinal surgery center, although its small sample size of 30 patients means the findings should be interpreted in that context.
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Castle Advances Precision Gastroenterology
TissueCypher is a molecular diagnostic test designed to provide a personalized five-year risk assessment for progression from Barrett’s esophagus to HGD or EAC. Castle says the test uses an AI-derived spatialomics approach to evaluate molecular signatures in standard esophageal biopsy tissue. The company reports that TissueCypher has been studied in biopsies from more than 8,000 patients and supported by more than 17 peer-reviewed publications. The September 28 publication adds to a growing body of evidence examining how TissueCypher may influence Barrett’s esophagus management. Castle also reported that findings from the study were presented at the American College of Surgeons Clinical Congress 2026 in Washington, D.C., on September 27.
For cGxP.wire readers, the study is significant because it demonstrates the growing use of molecular diagnostics and precision medicine in gastroenterology. Rather than relying solely on the initial NDBE diagnosis, TissueCypher is intended to provide additional information about an individual patient’s risk of disease progression. The reported management changes suggest potential clinical utility, although the study is a small real-world case series and does not by itself establish that the test improves long-term patient outcomes.
Source: Castle Biosciences press release
