Castle Biosciences, Inc. announced the publication of data demonstrating that the TissueCypher® Barrett?s Esophagus test outperformed standard of care pathology review in predicting malignant progression to HGD and EAC in BE patients with an initial diagnosis of LGD. The study findings are available online in Gastroenterology. The study evaluated the risk-stratification performance of TissueCypher in 154 BE patients with an initial community-based diagnosis of LGD with known progression/non-progression outcomes who were prospectively followed as part of the Surveillance versus Radiofrequency Ablation (SURF) trial.

The study aimed to compare the test?s performance against an international panel of 14 expert and 16 community-based, generalist pathologists from five countries. In the study, the TissueCypher test demonstrated higher sensitivity in detecting patients who progressed to HGD/EAC when compared to the panel of pathologists (71% vs. mean 63%, range 33-88% across 30 pathologists; p=0.01186).

Importantly, TissueCypher identified 43% of the progressors downstaged to NDBE by the pathologists (and 54.4% of the progressors downstaged to NDBE/IND) and could thus be missed by standard of care due to the variability in pathologist diagnoses. Use of the TissueCypher test in combination with pathology review identified 80.4% of patients who progressed, indicating that the test can increase the early detection of progressors when used with pathology. Additionally, patients with NDBE who received TissueCypher high-risk scores progressed to HGD/EAC at a rate of 21.4% within five years, which is higher than the published rate of progression in patients with expert pathologist-confirmed LGD (8.5% within 5 years).

This high-risk subset of BE patients who may be missed by standard of care pathology review can be detected early by the TissueCypher test, enabling intervention with endoscopic eradication therapy to prevent development of EAC, or close surveillance to detect dysplasia and EAC at early, treatable stages. Overall, the study demonstrated that TissueCypher can accurately predict progression to HGD or EAC in BE patients who are initially diagnosed with LGD in a community setting. Further, TissueCypher test results can provide an objective solution to variable pathology review, allowing physicians to make more informed management decisions for their patients, which may include upstaging care for patients at high risk for progression and reducing unnecessary interventions in low-risk patients.