TissueCypher in Barrett's Esophagus

Risk stratification assay for Barrett's esophagus — evidence, performance metrics, clinical risks & benefits, and when to use in practice. AGA 2025 identified TissueCypher as a knowledge gap.

GuidelinesAGA Practice Guideline (2025) · AGA CPU Expert Review (2022)Content reviewedMarch 2026

Disclosure: This module is for educational purposes only. No endorsement of TissueCypher (Cernostics) or any commercial diagnostic product is intended or implied. Content represents an objective review of published evidence and AGA guideline positions. Author (Dr. Rohit Singhania, MD, FACG) discloses no financial relationships with Cernostics or related entities.

📖 4 Sections⏱ ~25 min✅ 4-question quiz

What is TissueCypher?

Test overview, technology & AGA stance

TissueCypher Barrett's Test

TissueCypher (Cernostics) is a tissue systems pathology assay that uses machine-learning image analysis of Barrett's esophagus biopsy specimens to generate a risk score for progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). It analyzes 9 biomarkers across 3 cell compartments to produce a low, intermediate, or high-risk classification.

⚖️ AGA 2025 Guideline Position

The AGA 2025 guideline update made no recommendation for or against TissueCypher testing in Barrett's esophagus surveillance — explicitly identifying its role as a knowledge gap.

→Does not recommend routine use

→Does not recommend against its use

→Acknowledges the test may outperform histopathology alone in select patients

Evidence Base

Number of Studies

5 (1 cohort + 4 case-control)

Reviewed by AGA 2025

Certainty of Evidence

Very Low

Serious risk of bias & imprecision

2022 AGA CPG Expert Review

Favorable

Supports use in NDBE risk stratification

Clinical Experience Data

8,080 patients

Multicenter US study (Moinova et al.)

What the test measures

TissueCypher analyzes 9 biomarkers (including p53, AMACR, Aspirin, COX-2, HER2, CK7, MUC5AC, Ki-67, and nuclear morphology) using quantitative image analysis. Unlike standard pathology, the algorithm provides a continuous risk score that is independent of clinical variables such as segment length, sex, and age.

1. AGA Clinical Practice Guideline. Barrett's Esophagus. Gastroenterology 2025. 2. Critchley-Thorne RJ et al. AGA Clin Pract Update 2022.