TissueCypher Barrett’s esophagus assay impacts clinical decisions in the management of patients with Barrett’s esophagus

Abstract

Background and study aims The TissueCypher Barrett’s Esophagus Assay is a novel tissue biomarker test, and has been validated to predict progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with Barrett’s esophagus (BE). The aim of this study was to evaluate the impact of TissueCypher on clinical decision-making in the management of BE. Patients and methods TissueCypher was ordered for 60 patients with non-dysplastic (ND, n = 18) BE, indefinite for dysplasia (IND, n = 25), and low-grade dysplasia (LGD, n = 17). TissueCypher reports a risk class (low, intermediate or high) for progression to HGD or EAC within 5 years. The impact of the test results on BE management decisions was assessed. Results Fifty-two of 60 patients were male, mean age 65.2 ± 11.8, and 43 of 60 had long segment BE. TissueCypher results impacted 55.0 % of management decisions. In 21.7 % of patients, the test upstaged the management approach, resulting in endoscopic eradication therapy (EET) or shorter surveillance interval. The test downstaged the management approach in 33.4 % of patients, leading to surveillance rather than EET. In the subset of patients whose management plan was changed, upstaging was associated with a high-risk TissueCypher result, and downstaging was associated with a low-risk result (P < 0.0001). Conclusions TissueCypher was used as an adjunct to support a surveillance-only approach in 33.4 % of patients. Upstaging occurred in 21.7 % of patients, leading to therapeutic intervention or increased surveillance. These results indicate that the TissueCypher test may enable physicians to target EET for TissueCypher high-risk BE patients, while reducing unnecessary procedures in TissueCypher low-risk patients.

Prediction of Progression in Barrett’s Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies

“…In a recent study, an initial change in the clinical management was instituted in a majority of 60 patients with BE utilizing TissueCypher results, though a change in final outcome was not reported. 20 Implementation of such management changes on the basis of biomarker panel results combined with clinical variables will require additional prospective studies more precisely defining risk estimates, in a true surveillance population.…”

Utility of ancillary studies in the diagnosis and risk assessment of Barrett's esophagus and dysplasia

“…Using the company’s platform, a risk score for progression is stratified as low, intermediate, or high, but there is some advantage to combining the intermediate and high risk scores. Although similar data are reported in all studies from the TissueCypher team 51 , 52 , 54 – 56 , the initial and some recent studies were performed in Europe, and in 2020, a US-based study from two institutions was added 53 . The latter study was a case-control study from patients with biopsy diagnoses of negative for dysplasia ( n = 227), IND ( n = 23), and LGD ( n = 18).…”

Clinical variation in surveillance and management of Barrett’s esophagus: A cross-sectional study of gastroenterologists and gastrointestinal surgeons

“…This finding also reflects a potential benefit in increasing risk stratification methods, especially for those physicians who were unable to qualitatively identify the patient’s risk of progression to HGD/EAC. [ 31 ] Conversely, the NDBE cases had the lowest diagnostic and treatment scores perhaps because of the few interventions demonstrated by data to improve the already excellent prognosis of NDBE patients. While 90% or more of the BE surveillance population has NDBE, representing the majority of a gastroenterologist’s typical BE caseload.…”