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Systematic Review and Meta-Analysis Confirms TissueCypher® Outperforms Traditional Pathology or Clinical Factors Alone to Identify Patients at Increased Risk of Developing Esophageal Cancer
Globenewswire· 2025-12-12 12:00
Core Insights - Castle Biosciences, Inc. announced a systematic review and meta-analysis demonstrating that the TissueCypher® Barrett's Esophagus test provides clinically validated risk stratification for patients with Barrett's esophagus, outperforming traditional pathology or clinical factors in identifying patients at increased risk of developing esophageal cancer [1][2]. Group 1: Study Findings - The systematic review and meta-analysis consolidated data from six studies, confirming that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) [2]. - The study represents the most comprehensive validation of the TissueCypher test to date, reinforcing its value as an evidence-based tool for risk stratification in Barrett's esophagus [3][5]. - TissueCypher has been shown to be the strongest independent predictor of progression compared to traditional histopathological risk assessment, with high-risk results indicating patients are 6.7 times more likely to progress to HGD or EAC within five years than those with low-risk results [7][9]. Group 2: Clinical Implications - The findings support personalized, risk-aligned patient management aimed at preventing cancer, allowing physicians to identify which patients may benefit from earlier intervention and those who can continue routine surveillance [3][5]. - Patients with high or intermediate-risk results had an annual progression rate of 2.8%, while those with high-risk results had a rate of 5.6% per year, both exceeding the typical 1.7% annual progression rate for patients with low-grade dysplasia [9]. Group 3: Test Overview - TissueCypher is a precision medicine test designed to predict a patient's personalized risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma, indicated for patients with non-dysplastic BE, indefinite for dysplasia, or low-grade dysplasia [6]. - The test utilizes an AI-driven spatialomics approach to identify molecular signatures that precede dysplasia development, enabling earlier identification and management of patients at increased risk of cancer [7].