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

AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review

“…Finally, a recent pooled analysis of international studies in 472 patients with NDBE demonstrated that a high Tissue Cypher risk score was a strong independent predictor for progression to HGD/EAC (OR, 14.2; 95% CI, 5-39; P < .001). 39 Based on these data, the panel agreed that the Tissue Cypher assay may be of benefit for risk stratification of patients with NDBE.…”

Guideline to Practice: Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline

“…Its use to predict progression was not endorsed in the current guidelines because of insufficient evidence. WATS3D (CDx Diagnostics, Suffren, NY) is a computer-aided analysis of brush samples which, when used as an adjunct to biopsies, may increase the yield of dysplasia detection (11) while TissueCypher, a tissue systems pathology test, may better prognosticate risk of progression in BE than the traditionally used dysplasia grade (12). Insufficient evidence exists to allow a general recommendation for the use of either of these technologies, and more work is needed to define the role of adjuncts in risk stratification of BE and LGD.…”

Multicenter Randomized Controlled Trial of Surveillance Versus Endoscopic Therapy for Barrett’s Esophagus With Low-grade Dysplasia: The SURVENT Trial

“…A high-risk Tis-sueCypher score independently predicted a 7.81-fold increase in prevalent and incident HGD/EAC and significantly improved the predictive value of clinical features (age, sex, BE segment length, presence of hiatal hernia, and pathology diagnosis). 21 In a blinded, retrospective cohort study of BE patients with communitydiagnosed LGD enrolled in the surveillance arm of the SURF study, 5 TissueCypher stratified these LGD patients with overall predictive accuracy comparable with that of 3 expert gastrointestinal pathologists. 22 Moreover, TissueCypher provided objective risk stratification, whereas the diagnosis of LGD had significant To determine the utility of select biomarkers, including the biomarker panel TissueCypher, histologic assessment by WATS3D, and p53 IHC on forceps biopsies and on WATS3D samples, in risk stratification To conduct a safety and cost-effectiveness analysis Exploratory clinical endpoints will include progression to mucosal or invasive EAC alone, complete eradication rates for intestinal metaplasia (CE-IM) and complete eradication rates for dysplasia, and recurrence of intestinal metaplasia and dysplasia.…”