DOI: 10.1093/dote/doad052.129 ISSN:

303. THE TISSUE SYSTEMS PATHOLOGY-9 TEST PROVIDES CLINICALLY-IMPACTFUL RISK STRATIFICATION IN PATIENTS WITH BARRETT’S ESOPHAGUS: CLINICAL EXPERIENCE IN A MULTICENTER COHORT

Nicolas A Villa, Miguel Ordonez-Castellanos, Michael Yodice, Christian Smolko, Meenakshi Arora, Rebecca J Critchley-Thorne, Harshit S Khara, David L Diehl
  • Gastroenterology
  • General Medicine

Abstract

Background

Barrett’s esophagus (BE) is a precursor to esophageal adenocarcinoma (EAC). Society guidelines recommend surveillance of BE by endoscopy with biopsies with the goal of detecting dysplasia and EAC at early, treatable stages. However, current practices have limited ability to predict which patients with BE will progress to EAC. This study evaluated the use of the validated, commercially-available tissue systems pathology test (TissueCypher, TSP-9) to risk-stratify BE patients in a large clinical practice cohort.

Methods

TSP-9 test results ordered by 475 physicians from June 2016 to January 2023 for 3935 patients with BE with clinicopathologic data were analyzed. The test orders were from private practices and integrated healthcare systems (92.8%) and academic medical centers (7.2%). Submitted diagnoses were non-dysplastic BE (NDBE, n = 3553, 90.3%), indefinite for dysplasia (IND, n = 190, 4.8%), low-grade dysplasia (LGD, n = 112, 2.8%), or other (BE with sub-category not clearly specified, n = 80, 2.0%). The TSP-9 results (risk classes of low-, intermediate- or high-risk and predicted probability of progression to HGD/EAC within 5 years) were evaluated in all patients.

Results

The TSP-9 test scored 3267 (83.0%), 377 (9.6%), and 291 (7.4%) low-, intermediate- and high-risk, respectively. The TSP-9 test identified risk for progression in NDBE, IND, and LGD subsets, in males and females, and in patients with short- and long-segment BE (Fig. 1). The test scored 15.2% of NDBE patients as intermediate or high-risk. Patients with NDBE who received TSP-9 intermediate- and high-risk scores had predicted 5-year risk of progression to HGD/EAC of 8.1% and 16.2%, respectively, which are higher than progression rates in BE patients with LGD (6.7% in 5 years) for whom guidelines recommend endoscopic eradication therapy.

Conclusions

TSP-9 risk-stratified for progression independently of clinicopathologic features in a cohort of 3935 BE patients. The majority of BE patients scored low-risk, providing support for surveillance-only management. The test identified 15.2% of NDBE patients as intermediate/high-risk for progression, indicating that the test can enable early detection of patients who will benefit from escalation of care to prevent EAC. The TSP-9 test provides objective results to enable risk-aligned management to improve health outcomes for BE patients.

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