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

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<0.05). Additionally, consistent with the study reported above and several previously published studies, TissueCypher identified patients at a higher or lower risk of progression to HGD/EAC than indicated by their pathologic diagnosis to guide more informed and risk-aligned patient care.

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 15 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.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, uveal melanoma, Barrett’s esophagus and mental health conditions. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate-to-severe psoriasis, atopic dermatitis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DecisionDx-UM, DecisionDx-PRAME, DecisionDx-UMSeq, TissueCypher and IDgenetix are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: TissueCypher’s potential to (i) provide objective risk stratification that can identity patients who are likely to progress to EAC, (ii) aid physicians and patients in making risk-aligned patient management decisions, such as escalated or de-escalated care; and the continued ability of TissueCypher to predict future development of HGD and/or esophageal cancer in patients with BE. The words “can,” “could,” “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings, including with respect to the discussion of the TissueCypher® Barrett’s Esophagus test in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, our Quarterly Report on Form 10-Q for the three months ended June 30, 2023 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

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