Castle Biosciences, a leading diagnostics company, has announced the publication of data showing that its TissueCypher Barrett’s Esophagus test outperformed standard pathology review in predicting the progression of Barrett’s esophagus (BE) to more advanced stages. The study, published in Gastroenterology, evaluated the risk-stratification performance of the TissueCypher test in BE patients with an initial diagnosis of low-grade dysplasia (LGD).
Barrett’s esophagus is a condition where the lining of the esophagus becomes damaged, typically due to chronic acid reflux. It is a precursor to esophageal cancer, and accurately predicting which patients are at high risk for developing advanced forms of the disease or cancer can be challenging. The TissueCypher test, which utilizes Artificial Intelligence, provides a deeper analysis of a patient’s disease compared to traditional pathology review, offering objective information regarding the patient’s risk of progressing to esophageal cancer.
The study compared the performance of the TissueCypher test against an international panel of expert and community-based pathologists. The test demonstrated higher sensitivity in detecting patients who progressed to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) when compared to the panel of pathologists. Importantly, it also identified a significant number of progressors who were downstaged to non-dysplastic Barrett’s esophagus (NDBE) by the pathologists, potentially leading to missed diagnoses using standard care. When used in combination with pathology review, the TissueCypher test accurately identified a substantial majority of patients who progressed, indicating its potential for early detection.
The study further revealed that patients with NDBE who received high-risk scores from the TissueCypher test had a higher rate of progression to HGD/EAC within five years compared to patients with confirmed LGD by expert pathologists. This subset of patients, who may go undetected by standard care pathology review, can benefit from early intervention with endoscopic eradication therapy to prevent the development of esophageal adenocarcinoma.
The results of the study demonstrate that the TissueCypher Barrett’s Esophagus test can accurately predict the progression of low-grade dysplasia to more advanced stages. By providing an objective solution to the variability in pathology review, the test enables physicians to make more informed decisions regarding patient management, including upstaging care for high-risk patients and reducing unnecessary interventions for low-risk patients.
Castle Biosciences is focused on improving health through innovative tests that guide patient care. In addition to the TissueCypher test, the company’s portfolio includes tests for skin cancers, uveal melanoma, and mental health conditions. The company is also actively developing tests for other diseases with high clinical need.