New Data at American College of Gastroenterology Annual Meeting Show TissueCypher® Provides Actionable Risk Insights that Influence Clinical Management and Prompt Risk-Aligned Intervention in Barrett's Esophagus

Core Insights - Castle Biosciences announced new data showing that its TissueCypher® Barrett's Esophagus test provides risk insights beyond pathology, aiding in clinical management and supporting earlier interventions for patients at higher risk of progression to esophageal cancer [1][2] Group 1: Research Findings - The TissueCypher test identifies patients at higher risk of progression to esophageal cancer, which may be missed when relying solely on pathology [2] - New data from case studies indicate that TissueCypher returned high-risk results with five-year probabilities of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) of 34% and 62%, respectively, which are higher than the published rates of progression from HGD to EAC (33% over five years) [6] - In a study involving patients with non-dysplastic Barrett's esophagus (NDBE), TissueCypher identified high-risk patients with five-year probabilities of progression to HGD/EAC of 43% and 45%, leading to earlier interventions [6][13] Group 2: Clinical Impact - The TissueCypher test influenced clinical management in 93% of cases in a rural Texas study, allowing for timely interventions for higher-risk patients while reducing unnecessary procedures for lower-risk patients [13] - The test's ability to provide individualized risk stratification supports more personalized decisions around surveillance and intervention, potentially reducing the risk of progression to esophageal cancer [2][6] Group 3: Recognition and Presentation - The research findings will be presented at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting, with one abstract selected for a Presidential Poster Award, highlighting the quality and significance of the research [2][4] - A total of more than 6,400 scientific abstracts will be presented at the ACG 2025, with only a small percentage receiving the Presidential Poster Award [2] Group 4: About TissueCypher - The TissueCypher Barrett's Esophagus test is designed to predict future development of HGD and/or EAC in patients with Barrett's esophagus, and has been supported by 14 peer-reviewed publications [8] - The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022, indicating its clinical significance [8] Group 5: Company Overview - Castle Biosciences is a leading diagnostics company focused on improving health through innovative tests that guide patient care, with a portfolio that includes tests for skin cancers, Barrett's esophagus, and uveal melanoma [9][10] - The company is actively engaged in research and development for tests addressing high clinical needs, including a test for moderate-to-severe atopic dermatitis [10]