A Tissue Systems Pathology Test Outperforms the Standard of Care Variables in Predicting Progression in Patients with Barrett’s Esophagus

Abstract

Background: Objective risk stratification is needed for patients with Barrett’s esophagus (BE) to enable risk-aligned management to improve health outcomes. This study evaluated the predictive performance of a tissue systems pathology test (TissueCypher, TSP-9) versus current clinicopathologic variables in a multi-center cohort of BE patients. Methods: Data from 699 BE patients from five published studies on the TSP-9 test was evaluated. 509 patients did not progress during surveillance, 40 were diagnosed with HGD/EAC within 12 months, and 150 progressed to HGD/EAC after 12 months. Age, sex, segment length, hiatal hernia, original and expert pathology review diagnoses, and TSP-9 risk classes were collected. The predictive performance of clinicopathologic variables and TSP-9 was compared, and TSP-9 was evaluated in clinically relevant patient subsets. Results: The sensitivity of the TSP-9 test in detecting progressors was 62.3% compared to 28.3% for expert-confirmed LGD, while the original diagnosis abstracted from medical records did not provide any significant risk stratification. The TSP-9 test identified 57% of progressors with NDBE (P<0.0001). NDBE patients who scored TSP-9 high risk progressed at a similar rate (3.2%/year) to patients with expert-confirmed LGD (3.7%/year). The TSP-9 test provided significant risk stratification in clinically low-risk patients (NDBE, female, short-segment) and clinically high-risk patients (IND/LGD, male, long-segment) (p<0.0001 for comparison of high- vs. low-risk classes). Conclusions: The TSP-9 test predicts risk of progression to HGD/EAC independently of current clinicopathologic variables in BE patients. The test provides objective risk stratification results that may guide management decisions to improve health outcomes for BE patients.