American Gastroenterological Association Clinical Practice Update States That TissueCypher May Be Beneficial for Risk-Stratification of Patients with Non-Dysplastic Barrett’s Esophagus

TissueCypher® is a risk-stratification test that improves risk-appropriate clinical decision-making for patients diagnosed with non-dysplastic, indefinite or low-grade dysplasia Barrett’s esophagus

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that the American Gastroenterological Association (AGA) recently published a best practice advice article stating that the TissueCypher® Barrett’s Esophagus test may be beneficial for risk-stratification of patients with non-dysplastic Barrett’s esophagus (BE).

TissueCypher is Castle’s test for patients with BE that is designed to predict progression to high-grade dysplasia (HGD) and/or esophageal adenocarcinoma (EAC), a form of esophageal cancer. The best practice advice article from the AGA, titled “AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review,” was recently published online in Clinical Gastroenterology and Hepatology and can be viewed here.

“TissueCypher uses artificial intelligence to provide clinicians with critical information about a patient’s risk of developing HGD or EAC beyond what is possible through traditional pathology review,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “TissueCypher is designed to identify patients diagnosed with Barrett’s esophagus who may progress to HGD or EAC at a rate five to ten times higher than the current standard of care.1 This type of personalized risk-stratification information can potentially save lives when patients at high-risk of progression are identified early and provided with risk-appropriate treatments.”

“Current approaches for risk stratification of patients with BE, both in community practice and academic clinical settings, are limited to subjective systems that have failed to stem the rapid rise in the incidence of EAC over the last few decades,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “TissueCypher can be a game-changing innovation in this clinical area through its ability to identify patients at risk of progression to HGD and EAC, who are often missed due to reliance on traditional histopathology and clinical variables, and also predict future progression to esophageal cancer, two, three or even five years post endoscopy. Based on the published clinical data, the AGA agreed that TissueCypher may be beneficial as part of an improved care pathway for managing patients with BE.”

AGA Clinical Practice Update

AGA’s clinical practice updates present the current state-of-the-art guidance and include a combination of evidence-based information, and when not available, best consensus opinion concerning the management of gastrointestinal (GI) diseases.2 AGA’s latest update on BE was an expert review commissioned jointly by the AGA Institute Clinical Practice Updates Committee, the AGA Center for GI Innovation and Technology and the AGA Governing Board. It includes a number of Best Practice Advice statements (BPAs) intended to provide practical advice on the management of BE based on expert opinion and a review of existing literature.

The potential risk-stratification benefit of TissueCypher in the management of patients with BE is included in BPA 9 in the recent update: “Tissue systems pathology-based prediction assay may be utilized for risk-stratification of patients with non-dysplastic BE.”

Several clinical studies were cited as evidence in the BPA.3-6 These studies provide further support for the overall accuracy and strong, independent predictive ability of TissueCypher in risk-stratifying patients for progression to esophageal cancer, by identifying both high-risk patients who may be missed by the current standard of care as well as low risk patients who may be able to avoid unnecessary treatments.

About TissueCypher® Barrett’s Esophagus Test

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 nine 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.

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