Castle Biosciences, a diagnostic test provider for patient care, announced a new study published in The American Journal of Gastroenterology showing how use of TissueCypher Barrett’s Esophagus test results can significantly improve management decisions for Barrett’s esophagus (BE) patients with low-grade dysplasia (LGD) to improve health outcomes. The full study is available here.

“A significant challenge in the clinical management of Barrett’s esophagus is the inconsistency in diagnoses, and thus patient management, when relying solely on pathology review of biopsied tissue,” says Jacques Bergman, MD, PhD, study author, leading BE expert and Professor of Gastrointestinal Endoscopy at the University of Amsterdam and the Amsterdam University Medical Centers, the Netherlands. “As demonstrated in this study, TissueCypher test results offer a tool that may alleviate this challenge by providing objective and actionable risk-stratification that can improve patient care decisions, including the upstaging of care for high-risk patients and the downstaging of care for patients who are at low-risk for progression to more advanced dysplasia or esophageal cancer.”

The study involved a cohort of 154 real patients with community-based LGD and known progression/non-progression outcomes who were followed prospectively as part of the Surveillance versus Radiofrequency Ablation (SURF) trial. Management decision simulations were performed to determine the most likely care plan with or without use of TissueCypher, where each patient’s specimens were reviewed by 30 pathologists, leading to confirmation of dysplasia or downstaging to non-dysplastic Barrett’s esophagus (NDBE) or indefinite for dysplasia (IND). 

The study results showed the following:

  • Using TissueCypher test results to guide patient management decisions, in conjunction with the standard of care (SOC), significantly increased the likelihood of patients receiving appropriate management per their known outcome.
    • The median of patients receiving appropriate management in each simulation increased from 80.8% with SOC alone to 100% when TissueCypher test results were used to guide management decisions (p=0.0007).
  • Use of TissueCypher test results significantly improved the consistency of management decisions for patients by reducing the impact of variable pathology review (p<0.0001).
    • The percentage of patients with 100% of simulations resulting in appropriate management significantly increased from 9.1% with SOC pathology review to 58.4% when TissueCypher test results were used in conjunction with pathology, and further increased to 77.3% when only TissueCypher test results were used to guide management decisions.

Overall, the study results suggest that TissueCypher may be used to standardize the management of Barrett’s Esophagus patients with NDBE, IND and LGD. Broad use of TissueCypher test results should improve BE health outcomes by increasing the early detection of patients at a high risk of progression who can receive therapeutic interventions or close surveillance, both of which are effective strategies to reduce the incidence and mortality of esophageal adenocarcinoma. 

Further reading: How an AI Platform Increased Diagnostic Yield of Dysplasia in Barrett’s Esophagus

Use of the TissueCypher test may also improve health outcomes by identifying patients at a low risk of progression who can avoid unnecessary therapy and be managed using surveillance alone.

Featured image: This study evaluated the ability of a tissue systems pathology test that objectively risk stratifies patients with BE (TissueCypher, TSP-9) to standardize management in a manner consistent with improved health outcomes for patients with BE. Graphic: The American Journal of Gastroenterology