TissueCypher is Castle’s precision medicine risk-stratification test that predicts a patient’s individual risk of progression from Barrett’s esophagus (BE) to esophageal cancer

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a significant milestone for the Company’s TissueCypher Barrett’s Esophagus test, which surpassed 25,000 test reports delivered since the Company acquired the test at the end of 2021.

“At Castle, improving patient care is central to our mission,” said Toby Juvenal, chief commercial officer at Castle Biosciences. “We are extremely proud to have achieved this important milestone for our TissueCypher test, as we believe it means more clinicians are recognizing the value of the personalized, risk-aligned insights this test can provide, empowering them to make more informed decisions for their Barrett’s patients — decisions that could ultimately prevent an esophageal cancer diagnosis down the road.”

BE is the only known precursor to esophageal adenocarcinoma, the most common type of esophageal cancer.¹ Esophageal cancer is one of the fastest-growing cancers in incidence in the United States with a five-year survival rate of just 22%.² TissueCypher is the first AI-driven precision medicine test designed to determine a patient’s individual risk of progression from BE to esophageal cancer. The test is currently supported by 14 peer-reviewed clinical validation and utility studies that encompass one of the largest sets of BE progressor patients ever assembled.³ In these studies, TissueCypher consistently outperforms pathology diagnosis and BE segment length as predictors of progression, providing physicians with an actionable risk score and a patient's personalized five-year risk of progression. A low-risk test result can enable the extension of surveillance intervals or a reduction in unnecessary medical procedures for patients, while a high-risk result may prompt increased surveillance or intervention, like radiofrequency ablation, to help prevent a patient’s progression to esophageal cancer.

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 14 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. Learn more at www.CastleBiosciences.com.

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, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis 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, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq 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 ability of the TissueCypher test to (i) empower clinicians to make more informed decisions for their patients with BE that could ultimately prevent future esophageal cancer diagnoses; (ii) determine a patient’s individual risk of progression from BE to esophageal cancer; (iii) provide physicians with an actionable risk score and a patient's personalized five-year risk of progression; and (iv) help prevent unnecessary medical procedures. The words “can,” “would” 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 TissueCypher test 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, 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.

1. Curtius K, Rubenstein JH, Chak A, Inadomi JM. Computational modelling suggests that Barrett’s oesophagus may be the precursor of all oesophageal adenocarcinomas. Gut. Published online November 24, 2020:gutjnl-2020-321598. doi:10.1136/gutjnl-2020-321598. https://pubmed.ncbi.nlm.nih.gov/33234525/; accessed 11/5/24
2. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21820; accessed 11/5/24
3. TissueCypher published clinical validation and utility studies; https://castlebiosciences.com/Files/TC-006v3-052022%20Pub%20Clin%20Vali-Util%20Stds_INTERACTIVE%20%281%29.pdf; accessed 11/5/24

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