TissueCypher Scientific Evidence

Clinical evidence and peer reviewed studies

TissueCypher is supported by 14 published clinical validation and utility studies that encompass one of the largest sets of Barrett's esophagus (BE) progressor patients ever assembled. In these studies, TissueCypher consistently outperforms histology and segment length as predictors of progression.

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TissueCypher featured studies

Mayo Clinic Pooled Analysis

A pooled analysis of 590 patients showed that TissueCypher was a stronger predictor of progression than other clinicopathologic factors considered. For non-dysplastic patients a high-risk score was associated with an 18-fold increased risk vs. a low-risk score.

Clinical utility using the SURF cohort

Tissue from 154 patients from the SURF trial was evaluated by TissueCypher as well as 30 expert and general pathologists. Care plans were evaluated with and without guidance from TissueCypher and results indicated that TissueCypher may be used to standardize management of BE patients to improve health outcomes.

Prospective Decision Impact Study

TissueCypher significantly influenced decision-making in management of patients with BE. Comparison of posttest versus pretest management recommendations showed that the TissueCypher results changed 55.0 percent of management decisions regarding surveillance intervals and therapeutic interventions.

Risk-aligned management guided by the tissue systems pathology test can improve health outcomes in Barrett’s esophagus and reduce healthcare-associated costs

01 Oct 2024

A health economics study using a microsimulation model showed that TissueCypher-guided management is both cost-saving and helps improve patient health outcomes.
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Author:

Leggett C, et al.

TissueCypher is the strongest independent predictor of progression in patients with Barrett’s esophagus

01 SEPT 2024

TissueCypher has been shown to risk-stratify Barrett’s esophagus patients in five clinical validation studies. Given that clinical validation, this study was conducted in conjunction with Geisinger Medical Center to assess the impact of TissueCypher on clinicians’ management decisions.
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Author:

Souza, et al.

The tissue systems pathology test objectively risk-stratifies patients with Barrett’s esophagus results from a multicenter US clinical experience study

01 July 2024

This study highlights the clinical experience of TissueCypher testing ordered by 891 physicians in over 8,000 patients. This real-world clinical use of TissueCypher reflects the U.S. BE surveillance population with a significant proportion (93.9%) of diagnosed cases having NDBE and 94.3% of orders originating from community-based practices

Author:

Villa N, et al.

A randomized controlled study on clinical adherence to evidence-based guidelines in the management of simulated patients with Barrett’s esophagus and the clinical utility of a tissue systems pathology test: results from Q-TAB

12 JAN 2024

TissueCypher optimized adherence to clinical guidelines for surveillance and treatment of both BE patients at high and low risk for disease progression. Use of the test can enable physicians to make risk-aligned management decisions, leading to improved patient health outcomes.
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Author:

Peabody J, et al.

An Automated Tissue Systems Pathology Test Can Standardize the Management and Improve Health Outcomes for Patients with Barrett's Esophagus

01 NOV 2023

Management guided by the TissueCypher test can standardize care plans by increasing the early detection of progressors who can receive therapeutic interventions, while also increasing the percentage of nonprogressors who can avoid unnecessary therapy and be managed by surveillance alone.

Author:

Duits L, et al.

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Clinical evidence and peer reviewed studies

TissueCypher featured studies

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Risk-aligned management guided by the tissue systems pathology test can improve health outcomes in Barrett’s esophagus and reduce healthcare-associated costs

TissueCypher is the strongest independent predictor of progression in patients with Barrett’s esophagus

The tissue systems pathology test objectively risk-stratifies patients with Barrett’s esophagus results from a multicenter US clinical experience study

A randomized controlled study on clinical adherence to evidence-based guidelines in the management of simulated patients with Barrett’s esophagus and the clinical utility of a tissue systems pathology test: results from Q-TAB

An Automated Tissue Systems Pathology Test Can Standardize the Management and Improve Health Outcomes for Patients with Barrett's Esophagus

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