Castle Biosciences to Present New Data on its TissueCypher® Barrett’s Esophagus Test at the 2023 American College of Gastroenterology Annual Scientific Meeting

Two posters highlight ability of the TissueCypher test to identify higher- and lower-risk subsets of patients with Barrett’s esophagus than indicated by their clinicopathologic factors to guide risk-aligned patient care

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will highlight the impactful risk stratification provided by its TissueCypher® test in patients with Barrett’s esophagus (BE) through two posters at the 2023 American College of Gastroenterology (ACG 2023) Annual Scientific Meeting, taking place Oct. 20-25, in Vancouver, Canada.

“The large majority of patients undergoing surveillance for BE in the U.S. have a pathology diagnosis of non-dysplastic Barrett’s esophagus (NDBE), which carries the lowest risk of developing esophageal adenocarcinoma (EAC) according to the patient’s clinicopathologic factors, such as their age, sex and BE segment length,” said David L. Diehl, M.D., board-certified and fellowship-trained gastroenterologist, director of advanced endoscopy fellowship at Geisinger Medical Center, adjunct associate professor of medicine at New York University School of Medicine, clinical professor of medicine at Geisinger Commonwealth School of Medicine and senior author of Castle’s posters at ACG 2023. “However, we find that at least half of the patients who progress to EAC come from this “low-risk” population, which tells us that there is a critical need to improve our risk-stratification of these patients. The TissueCypher test can help by providing objective risk stratification that can identity patients who are likely to progress to EAC and may benefit from escalated management strategies to potentially help prevent a future cancer diagnosis.”

Castle’s posters will be available for viewing today, Tuesday, Oct. 24, from 10:30 a.m.-4 p.m., with presenting authors available to answer questions from 1-2:15 p.m., all times Pacific.

P3265: The Tissue Systems Pathology Test Objectively Risk-Stratifies Patients with Barrett’s Esophagus: A Multicenter U.S. Clinical Experience Study (view poster here)

In the multi-center study, TissueCypher provided impactful risk stratification within all BE patient subsets (n=5,350) according to patients’ risk of progressing to high-grade dysplasia (HGD)/EAC within five years. In patients with lower-risk clinicopathologic factors (females with a pathology diagnosis of NDBE), TissueCypher identified intermediate/high-risk patients who were predicted to progress at a higher rate than patients with low-grade dysplasia (LGD) and may benefit from escalated care to potentially prevent HGD/EAC. In patients with higher-risk clinicopathologic factors (males with a pathology diagnosis of indefinite for dysplasia (IND) or LGD), TissueCypher identified low-risk patients with predicted progression rates similar to patients with NDBE. This finding indicates that there are low-risk patients with IND who may be effectively managed by long interval surveillance, and low-risk patients with LGD who may be effectively managed by short interval surveillance instead of endoscopic eradication therapy, as suggested by guidelines.

Overall, the data show the risk stratification provided by the TissueCypher test can aid physicians and patients in making risk-aligned patient management decisions, such as escalated or de-escalated care, which may lead to improved health outcomes.

P3264: The Tissue Systems Pathology Test Predicts Risk of Progression in Medicare-Eligible Patients with Barrett’s Esophagus (view poster here)

The study evaluated the risk-stratification performance of the TissueCypher test in two cohorts of Medicare-eligible patients (65 years of age or older) with BE: a clinical outcomes cohort (n=290) for which patients’ outcomes were known, and a clinical use cohort from TissueCypher orders over the last seven years (n=2,828). TissueCypher provided significant risk-stratification in both cohorts. In the clinical outcomes cohort, the test demonstrated significantly higher sensitivity in detecting patients who progressed to HGD/EAC (64.0%; 95% CI 53.3-74.7) when compared to real-world or expert pathology diagnoses of LGD (38.7%; 95% CI 28.0-49.3 and 22.6%; 95% CI 13.3-33.3, respectively; p