Castle Biosciences, Inc. announced that the latest American Gastroenterological Association (AGA) clinical practice guideline recognized that not all patients with non-dysplastic BE (NDBE) are at low risk of developing esophageal cancer. The guideline acknowledges the role that tissue-based biomarkers, including the tissue systems pathology test (TissueCypher, also known as TSP-9), can play in identifying high-risk NDBE patients who may benefit from endoscopic eradication therapy (EET) to prevent disease progression. BE with high-risk features can often be effectively treated with EET, such as ablation, which involves either burning or freezing the abnormal esophageal lining.

However, the ability to reliably identify patients at increased risk of progression is crucial to avoid missing patients who develop esophageal cancer as well as limiting the over treatment of patients who have a lower risk of progression. Studies have shown that TissueCypher is an independent predictor of progression in patients with BE. Further, a pooled analysis of clinical data from the Mayo Clinic showed that patients with NDBE, traditionally deemed to be at a lower risk of advancing to esophageal cancer, who receive TissueCypher high-risk scores, are 18-times more likely to progress than patients with low-risk scores.

In the recently published AGA guideline, the expert panel of authors acknowledge the role that tissue-based biomarkers (particularly aberrant p53 or TissueCypher, alone or in combination with clinical and endoscopic characteristics) can play in stratifying the large pool of patients with NDBE to help identity those at high risk of progression for consideration of treatment with EET at an early, precancerous stage. The TissueCypher Barrett?s Esophagus test is Castle?s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett?s esophagus (BE). The TissueCypher Barrett?s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (NDBE), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by 13 peer-reviewed publications of BE progressor patients with leading clinical centers around the world.

The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.