Castle Biosciences’ TissueCypher® Test Demonstrates Potential to Guide Clinical Decisions in Non-Dysplastic Barrett’s Esophagus Patients
Castle Biosciences, a leader in advanced laboratory developed tests for cancer, has unveiled new data illustrating the clinical value of its TissueCypher® Barrett’s Esophagus test in guiding treatment decisions for patients with non-dysplastic Barrett’s esophagus (NDBE) who are at a heightened risk of progressing to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC), a risk that may not be evident through traditional clinicopathologic risk assessments. The new data was recently presented via a poster at the annual meeting of the American Foregut Society (AFS), was titled “A Tissue Systems Pathology Test Enables Risk-Aligned Management of Patients with Non-Dysplastic Barrett’s Esophagus: Case Reports from a Gastrointestinal Surgery Center.”
Barrett’s esophagus is a condition caused by acid reflux damage to the esophagus lining, leading to its thickening and reddening. It typically results from long-term gastroesophageal reflux disease (GERD), where the lower esophageal sphincter (LES) may weaken, allowing acid damage. GERD symptoms often include heartburn and regurgitation. Barrett’s esophagus increases the risk of esophageal cancer, The general population of NDBE patients is typically considered low risk for disease progression based on traditional clinicopathologic risk factors. According to the National Institute of Health, Barrett’s Esophagus impacts approximately 5.6% of the U.S. population or around 18 million individuals. 490,000 patients undergo endoscopic surveillance of the disease in the U.S. annually.
Dr. Daniel Tseng, a surgeon at the Northwest Minimally Invasive Surgery Center in Portland, Oregon, and the lead author of the study, emphasized the importance of accurately identifying patients with NDBE who are most likely to progress to severe conditions. Patients at high risk of developing esophageal cancer can have options including various therapeutic strategies such as endoscopic eradication therapies (EET) like radiofrequency ablation (RFA) or cryoablation, along with anti-reflux surgery to halt chronic esophageal injury. The case study underscored TissueCypher’s capability to identify NDBE patients with a high to intermediate risk of progressing to HGD/EAC. These patients exhibited a predicted 5-year risk of progression similar to the published estimates for patients with confirmed low-grade dysplasia (LGD), a condition linked to a higher progression risk, thereby recommending EET such as RFA. Identifying NDBE patients with a similar progression risk to LGD allows physicians and their patients to consider a risk-aligned approach to healthcare, preventing the development of EAC and ultimately improving overall health outcomes.
The TissueCypher Barrett’s Esophagus test is a precision medicine test designed to predict the likelihood of high-grade dysplasia (HGD) and esophageal cancer development in patients diagnosed with Barrett’s esophagus (BE). The test is intended for use in patients with endoscopic biopsy-confirmed BE, including non-dysplastic (NDBE), indefinite for dysplasia (IND), or low-grade dysplasia (LGD). In a recent pooled analysis from Mayo Clinic using TissueCypher, the test demonstrated high predictive power for the progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). It significantly outperformed other clinical and pathological factors in predicting this progression with an odds ratio of 18x meaning those with a high-risk score from TissueCypher showed an 18-fold increased risk of progressing to HGD or EAC compared to those with a low-risk score. TissueCypher successfully identified 52% of the NDBE progressors, all of whom would have been overlooked by the standard of care. These findings were derived from a comprehensive analysis of pooled patient data from five clinical studies of 590 patients.