Castle Biosciences, Inc. (NASDAQ:CSTL), a company improving health through innovative tests that guide patient care, today announced new study data demonstrating the ability of its TissueCypher® Barrett’s Esophagus test to independently predict malignant progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with non-dysplastic (ND), indefinite or low-grade dysplasia (LGD) Barrett’s esophagus (BE). The TissueCypher Barrett’s Esophagus test is designed to predict future development of HGD and/or esophageal cancer in patients with BE.
In the study, TissueCypher outperformed standard of care in predicting malignant progression in a review of surveillance biopsies from 154 BE patients that were independently reviewed by 30 pathologists. Importantly, TissueCypher identified more than 40% of the patients with LGD who progressed to HGD or EAC who were, on average, downstaged to NDBE by the pathologists, and would thus be missed by standard of care (due to the variability of pathologist diagnoses).
Details of the study were shared in a podium presentation at Digestive Disease Week (DDW) 2022. The presentation was titled, “An Objective, Fully Automated Barrett’s Risk Prediction Assay Outperforms Pathology in Risk Stratifying Barrett’s Esophagus with Low-Grade Dysplasia.”
Jacques Bergman, M.D., Ph.D., corresponding study author, leading BE expert and professor of gastroenterology and hepatology at University Medical Center in Amsterdam, Netherlands, presented the data. University Medical Center is one of the world’s leading academic medical institutions in the area of diagnosis and treatment of BE and esophageal cancer prevention.
“There is extreme variability between pathologist observers in the diagnosis of BE, and a patient’s care plan and long-term outcome can vary widely depending on which pathologist provides the diagnosis. This is why the TissueCypher test has the potential to provide substantial value in the management of BE patients,” said Bergman. “As shown in the study, TissueCypher can improve the risk-stratification of patients with BE to more accurately identify those at highest risk for progression to esophageal cancer to ensure their management plans can be tailored appropriately with early and potentially life-saving interventions.”
The purpose of the study was to evaluate the predictive value of TissueCypher in 154 BE patients with a community-based diagnosis of LGD, and to benchmark the test’s performance against an international panel of 15 expert and 15 community-based, generalist pathologists. In the study, the panel of pathologists identified 63% of the patients (sensitivity) who progressed to HGD or EAC. In comparison, TissueCypher identified 71% (sensitivity) of the progressors, and the combination of TissueCypher plus pathology review identified 80%. Importantly, TissueCypher identified 43% of the patients who were downstaged from LGD to NDBE by the panel of pathologists but later progressed to HGD or EAC. Thus, in both measures in this study, TissueCypher outperformed pathology review (on an average basis across all 30 participating pathologists).
Overall, the study demonstrated that TissueCypher can accurately predict progression to HGD or EAC in BE patients who are initially diagnosed with LGD, outperforming the majority of pathologist diagnoses evaluated in this study. Further, TissueCypher test results may provide an objective solution to observer variability, identifying more progressors early and helping to inform management decisions and standardize care plans for patients with BE.
