FRIENDSWOOD, TEXAS, May 04, 2026
Castle Biosciences has announced the presentation of new clinical data at Digestive Disease Week (DDW) 2026 demonstrating that its TissueCypher® molecular test significantly improves risk stratification and clinical decision-making in Barrett’s esophagus (BE). The findings, generated by researchers at Mayo Clinic, highlight the test’s ability to provide personalized five-year risk predictions for progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Importantly, the data show that TissueCypher directly influences physician management strategies, enabling more precise, risk-aligned patient care compared to traditional histopathology-based assessments.
Molecular Risk Stratification Enhances Clinical Decision-Making
The data presented at DDW 2026 demonstrate that TissueCypher testing led to changes in surveillance intervals in 55% of patients, indicating a significant impact on real-world clinical practice. Physicians aligned their recommendations with TissueCypher risk classifications in 79% of cases, with 93% of intermediate- and high-risk patients receiving intensified surveillance strategies.
These findings underscore the limitations of traditional clinical and histopathologic risk models, which may fail to accurately identify patients at risk of disease progression. By integrating molecular biomarkers and disease biology, TissueCypher enables clinicians to differentiate between low-risk and high-risk patients more effectively, supporting personalized treatment and monitoring strategies. This advancement reflects the growing importance of precision diagnostics in gastroenterology, where early detection and risk stratification are critical to preventing cancer progression.
AI-Driven Spatialomics Technology Improves Risk Prediction
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TissueCypher utilizes an AI-driven spatialomics platform to analyze molecular signatures within esophageal biopsy samples, identifying changes that often precede visible histological abnormalities. This approach allows for earlier and more accurate detection of disease progression risk, enabling clinicians to intervene proactively. The test has been validated in studies involving more than 8,000 patient samples and is supported by over 17 peer-reviewed publications, reinforcing its credibility as a robust diagnostic tool.
Unlike conventional methods, TissueCypher provides a quantitative, biology-driven risk score, which can guide decisions such as endoscopic eradication therapy (EET) or adjustments in surveillance intervals. This capability is particularly important in Barrett’s esophagus, where disease progression to cancer can be unpredictable, and timely intervention can significantly improve patient outcomes.
Advancing Precision Diagnostics and Clinical Practice
The integration of TissueCypher into clinical workflows represents a major step forward in precision medicine and diagnostic innovation, enabling more efficient use of healthcare resources while improving patient outcomes.
From a GxP perspective, the development and validation of the test align with Good Clinical Practice (GCP) and diagnostic regulatory standards, ensuring data reliability, reproducibility, and clinical utility. Barrett’s esophagus affects millions globally and is a known precursor to esophageal adenocarcinoma, a cancer with high mortality rates when detected late, emphasizing the need for accurate risk assessment tools.
By providing actionable insights that influence real-world clinical decisions, TissueCypher has the potential to transform the standard of care, enabling earlier intervention for high-risk patients and reducing unnecessary procedures for low-risk individuals. This innovation highlights Castle Biosciences’ commitment to advancing personalized medicine through cutting-edge diagnostics, positioning the company as a leader in molecular testing and precision healthcare solutions.
Source: Castle Biosciences press release
