An Automated Tissue Systems Pathology Test Can Standardize the Management and Improve Health Outcomes for Patients With Barrett's Esophagus

Abstract

Introduction: Low-grade dysplasia (LGD) in Barrett's esophagus (BE) is associated with an increased risk of progression to high-grade dysplasia or esophageal adenocarcinoma. However, because of substantial interobserver variability in the diagnosis of LGD, a patient's management plan and health outcome depend largely on which pathologist reviews their case. This study evaluated the ability of a tissue systems pathology test that objectively risk stratifies patients with BE (TissueCypher, TSP-9) to standardize management in a manner consistent with improved health outcomes for patients with BE.

Methods: A total of 154 patients with BE with community-based LGD from the prospectively followed screening cohort of the SURF trial were studied. Management decisions were simulated 500 times with varying generalist (n = 16) and expert (n = 14) pathology reviewers to determine the most likely care plan with or without use of the TSP-9 test for guidance. The percentage of patients receiving appropriate management based on the known progression/nonprogression outcomes was calculated.

Results: The percentage of patients with 100% of simulations resulting in appropriate management significantly increased from 9.1% for pathology alone, to 58.4% when TSP-9 results were used with pathology, and further increased to 77.3% of patients receiving appropriate management when only TSP-9 results were used. Use of the test results also significantly increased the consistency of management decisions for patients when their slides were reviewed by different pathologists ( P < 0.0001).

Discussion: Management guided by the TSP-9 test can standardize care plans by increasing the early detection of progressors who can receive therapeutic interventions, while also increasing the percentage of nonprogressors who can avoid unnecessary therapy and be managed by surveillance alone.

Graphical abstract

Figure 1.

Surveillance and management decision models. (a) SOC management arm where patients were managed per current guidelines. (b) TissueCypher (TSP-9)-guided management decision model combining the SOC with guidance from the test. (c) TissueCypher (TSP-9)-guided management decision model where test results were used in conjunction with 1 pathology diagnosis (no secondary review of LGD). LGD, low-grade dysplasia; SOC, standard of care; TSP-9, tissue systems pathology test.

Figure 2.

Use of the TSP-9 test in conjunction with the SOC increased the likelihood of patients receiving appropriate management. (a) Likelihood of receiving appropriate management using SOC vs SOC with guidance from the TSP-9 test. (b) Percentage of simulated management decisions for surveillance or therapy in progressors (n = 24). (c) Percentage of simulated management decisions for surveillance or therapy in nonprogressors (n = 130). (d) Variability in management decisions for patients managed per SOC vs SOC with guidance from the TSP-9 test. See Methods for definition of appropriate management. SOC, standard of care; TSP-9, tissue systems pathology test.

Figure 3.

Use of the TSP-9 test in conjunction with 1 pathology diagnosis increased the likelihood of appropriate management decisions. (a) Likelihood of receiving appropriate management using SOC vs a single pathology review with guidance from the TSP-9 test. (b) Percentage of simulated management decisions for surveillance or therapy in progressors (n = 24). (c) Percentage of simulated management decisions for surveillance or therapy in nonprogressors (n = 130). (d) Variability in management decisions for patients managed per SOC vs the TSP-9 test in conjunction with a single pathology review. SOC, standard of care; TSP-9, tissue systems pathology test.