The study consolidating data from six published studies confirms the test outperforms traditional pathology or clinical factors alone in identifying esophageal cancer risk.
A new systematic review and meta-analysis has validated the clinical performance of Castle Biosciences’ TissueCypher Barrett’s Esophagus test, demonstrating its ability to identify patients at increased risk of developing esophageal cancer more effectively than traditional pathology or clinical factors alone.
The study, published in the Journal of Clinical Gastroenterology, consolidated data from six previously published studies and found that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia or esophageal adenocarcinoma. The analysis represents the most extensive validation of the TissueCypher test to date.
“Our findings provide strong evidence that TissueCypher delivers meaningful risk stratification for patients with Barrett’s esophagus,” says Caitlin C Houghton, MD, board-certified foregut surgeon at Keck Medicine of USC in Los Angeles and lead author of the study, in a release. “By identifying which patients are truly at high risk for progression to esophageal cancer—and which are not—TissueCypher can help physicians personalize care, flagging those who may benefit from earlier intervention and providing confidence in continuing routine surveillance for those at low risk.”
Test Performance Across Patient Categories
The meta-analysis examined TissueCypher’s predictive performance across patients with non-dysplastic Barrett’s esophagus, indefinite for dysplasia, and low-grade dysplasia. Results showed the test outperforms histologic assessment in identifying patients at greatest risk of progression.
Systematic reviews and meta-analyses represent high-quality evidence for clinical validation by synthesizing findings across multiple studies to provide overall performance estimates. The study demonstrates that TissueCypher provides consistent, reproducible performance and supports its potential to help physicians deliver risk-aligned care.
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