New Publication Highlights the Ability of the TissueCypher® Barrett’s Esophagus Test to Improve and Standardize the Clinical Management of Low-Grade Dysplasia in Patients with Barrett’s Esophagus

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a new study published in The American Journal of Gastroenterology showing how use of TissueCypher® Barrett’s Esophagus test results can significantly improve management decisions for Barrett’s esophagus (BE) patients with low-grade dysplasia (LGD) to improve health outcomes. The full study is available here.

“A significant challenge in the clinical management of Barrett’s esophagus is the inconsistency in diagnoses, and thus patient management, when relying solely on pathology review of biopsied tissue,” said Jacques Bergman, M.D., Ph.D., study author, leading BE expert and Professor of Gastrointestinal Endoscopy at the University of Amsterdam and the Amsterdam University Medical Centers, the Netherlands. “As demonstrated in this study, TissueCypher test results offer a tool that may alleviate this challenge by providing objective and actionable risk-stratification that can improve patient care decisions, including the upstaging of care for high-risk patients and the downstaging of care for patients who are at low-risk for progression to more advanced dysplasia or esophageal cancer.”

The study involved a cohort of 154 real patients with community-based LGD and known progression/non-progression outcomes who were followed prospectively as part of the Surveillance versus Radiofrequency Ablation (SURF) trial. Management decision simulations were performed to determine the most likely care plan with or without use of TissueCypher, where each patient’s specimens were reviewed by 30 pathologists, leading to confirmation of dysplasia or downstaging to non-dysplastic Barrett’s esophagus (NDBE) or indefinite for dysplasia (IND). The study results showed the following:

• Using TissueCypher test results to guide patient management decisions, in conjunction with the standard of care (SOC), significantly increased the likelihood of patients receiving appropriate management per their known outcome.
  • The median of patients receiving appropriate management in each simulation increased from 80.8% with SOC alone to 100% when TissueCypher test results were used to guide management decisions (p=0.0007).
• Use of TissueCypher test results significantly improved the consistency of management decisions for patients by reducing the impact of variable pathology review (p<0.0001).
  • The percentage of patients with 100% of simulations resulting in appropriate management significantly increased from 9.1% with SOC pathology review to 58.4% when TissueCypher test results were used in conjunction with pathology, and further increased to 77.3% when only TissueCypher test results were used to guide management decisions.

Overall, the study results suggest that TissueCypher may be used to standardize the management of BE patients with NDBE, IND and LGD. Broad use of TissueCypher test results should improve BE health outcomes by increasing the early detection of patients at a high risk of progression who can receive therapeutic interventions or close surveillance, both of which are effective strategies to reduce the incidence and mortality of esophageal adenocarcinoma. Use of the TissueCypher test may also improve health outcomes by identifying patients at a low risk of progression who can avoid unnecessary therapy and be managed using surveillance alone.

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). TissueCypher is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by ten peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U). Additionally, the test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022 and was recognized by the American Gastroenterological Association (AGA) in their 2022 Clinical Practice Update as a tool that may be used to risk-stratify patients with NDBE.

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, Twitter 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: the potential of TissueCypher test results to (i) significantly improve management decisions for BE patients with LGD to improve health outcomes; (ii) serve as a tool that may provide objective and actionable risk-stratification that can improve patient care decisions; (iii) standardize the management of BE patients with NDBE, IND and LGD; (iv) improve BE health outcomes by increasing the early detection of patients at a high risk of progression who can receive therapeutic interventions or close surveillance; and (v) improve health outcomes by identifying patients at a low risk of progression who can avoid unnecessary therapy and be managed using surveillance alone. The words “can,” “may,” “potential” 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 or may not support the results shown in this study, including with respect to the discussion of TissueCypher 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 Quarterly Report on Form 10-Q for the quarter 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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