DOI: 10.14309/ctg.0000000000000631 ISSN:

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

Jon M. Davison, John R. Goldblum, Lucas C. Duits, Amir M. Khoshiwal, Jacques J. Bergman, Gary W. Falk, David L. Diehl, Harshit S. Khara, Christian Smolko, Meenakshi Arora, Jennifer J. Siegel, Rebecca J. Critchley-Thorne, Prashanthi N. Thota
  • Gastroenterology

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.

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