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FRIENDSWOOD, Texas--( BUSINESS WIRE )--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will present new data supporting the ability of its TissueCypher Barrett’s Esophagus test (TSP-9) to independently predict risk of progression to esophageal cancer in patients with Barrett’s esophagus (BE) at the American Foregut Society (AFS) 2024 Annual Meeting, being held Sept. 25-29, 2024, in Denver. “The large majority of patients in BE surveillance programs have non-dysplastic BE (NDBE), and so they fall into what is considered a low-risk category in which they are advised to see their doctor every three to five years for an endoscopy,” said Rhonda F. Souza, M.D., gastroenterologist, co-director of the Center for Esophageal Research at Baylor Scott & White Research Institute and co-director of the Center for Esophageal Diseases at Baylor University Medical Center in Dallas. “However, many BE patients who go on to develop esophageal cancer come from this allegedly low-risk group. Our study shows that traditional clinicopathologic variables are not helpful in predicting the risk of neoplastic progression in patients with NDBE, and TSP-9 testing is far superior in this regard. Rather than delaying surveillance for years, we think that patients identified as high-risk by TSP-9 would benefit from more intensive surveillance or endoscopic eradication therapy.” “TissueCypher is the first test of its kind developed to offer a solution for this clinical challenge,” said Rebecca Critchley-Thorne, Ph.D., vice president of research and development at Castle Biosciences. “The test continues to demonstrate its substantial value in helping physicians tailor their treatment plans for BE patients based on their likelihood of developing esophageal cancer.” Details regarding Castle’s presentations at AFS 2024 are included below: Oral presentation: TissueCypher is the strongest independent predictor of progression in patients with Barrett’s esophagus Presenting Author: Rhonda F. Souza, M.D Date & Time: Saturday, Sept. 28, 11:50 a.m.–12 p.m. Mountain Time Summary: The study aimed to evaluate whether routinely available clinicopathologic factors used to risk stratify patients with BE, including age, sex, BE segment length, hiatal hernia and original pathology diagnosis (non-dysplastic Barrett’s esophagus (NDBE), indefinite for dysplasia (IND) and low-grade dysplasia (LGD)), could be combined with the patient’s TissueCypher risk score to improve the accuracy of predicting progression to high grade dysplasia (HGD) or esophageal cancer within five years. The study showed that the addition of clinicopathologic factors did not improve the predictive performance of the TissueCypher test; in fact, TissueCypher, used alone, was the strongest predictor of progression. In patients with NDBE, TissueCypher was the only significant predictor of progression, supporting its significant clinical utility in identifying high-risk patients in this large population to help determine which may benefit from increased surveillance or early interventions to prevent cancer. Poster # 42: The tissue systems pathology test guides risk-aligned management decisions in patients with non-dysplastic Barrett's esophagus Date & Time: Friday, Sept. 27, 12:45–12:50 p.m. Mountain Time Summary: This study evaluated the clinical utility of the TissueCypher test in guiding risk-aligned clinical management decisions for a series of consecutive patients with NDBE (n=14) at an expert foregut surgery center. The patients received prospective TissueCypher testing, and the ordering physician completed a questionnaire describing their reason for ordering the test, their management plan before and after receiving the test results, and how the test results impacted their management decisions. The study data showed a significant association between patients’ TissueCypher risk class and subsequent management decisions (P=0.01099), with 86% of patients being managed in alignment with their risk of progression to HGD or esophageal cancer according to the test’s results. Use of TissueCypher test results led to upstaged management in 21% of patients, such as the use of endoscopic eradication therapy to help prevent progression to esophageal cancer. The test also supported long-interval surveillance (3-5 years), consistent with guideline recommendations, in 90% of low-risk patients. These data highlight the clinical value of the TissueCypher test in guiding risk-aligned management decisions for patients with NDBE and increasing physician confidence in those decisions. 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-CM Seq , DecisionDx-SCC, MyPath Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq 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: (i) Castle’s ability to advance care for patients with BE; (ii) the ability of the TissueCypher test to be the strongest predictor of risk of progression to esophageal cancer in patients with BE based on published studies; and (iii) the ability of the TissueCypher test to guide important patient management decisions, including upstaging care for high-risk patients and supporting long-interval surveillance for patients at low risk of progression. 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, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 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.

Castle’s TissueCypher test has been shown to improve the risk stratification of patients with Barrett’s esophagus (BE)1,2 FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that the latest American Gastroenterological Association (AGA) clinical practice guideline recognized that not all patients with non-dysplastic BE (NDBE) are at low risk of developing esophageal cancer. The guideline acknowledges the role that tissue-based biomarkers, including the tissue systems pathology test (TissueCypher, also known as TSP-9), can play in identifying high-risk NDBE patients who may benefit from endoscopic eradication therapy (EET) to prevent disease progression.3 BE with high-risk features can often be effectively treated with EET, such as ablation, which involves either burning or freezing the abnormal esophageal lining. However, the ability to reliably identify patients at increased risk of progression is crucial to avoid missing patients who develop esophageal cancer as well as limiting the over treatment of patients who have a lower risk of progression. Studies have shown that TissueCypher is an independent predictor of progression in patients with BE. Further, a pooled analysis of clinical data from the Mayo Clinic showed that patients with NDBE, traditionally deemed to be at a lower risk of advancing to esophageal cancer, who receive TissueCypher high-risk scores, are 18-times more likely to progress than patients with low-risk scores.1 In the recently published AGA guideline, the expert panel of authors acknowledge the role that tissue-based biomarkers (particularly aberrant p53 or TissueCypher, alone or in combination with clinical and endoscopic characteristics) can play in stratifying the large pool of patients with NDBE to help identity those at high risk of progression for consideration of treatment with EET at an early, precancerous stage. “We are pleased that the AGA has recognized that there is a high-risk subset of NDBE patients who may benefit from early intervention with EET and importantly, have acknowledged that tissue-based biomarker testing can help identify these patients,” said Emmanuel Gorospe, M.D., board-certified gastroenterologist and GI medical director at Castle Biosciences. “This clinical need was the driving factor behind the development of the TissueCypher test, which provides a deeper look into a patient’s esophageal tissue to identify molecular signs of progression that may lead to cancer down the road.” In 2022, the AGA’s “Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus” included a best practice advice statement that said TissueCypher may be utilized for the risk-stratification of patients with NDBE.4 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 13 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 . 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 and connect with us on LinkedIn, Facebook, X and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, 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: TissueCypher’s continued ability to (i) be an independent predictor of progression in patients with BE and (ii) help stratify the large pool of patients with NDBE to help identity those at high-risk of progression for consideration of treatment with EET at an early, precancerous stage 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, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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. Iyer PG, Codipilly DC, Chandar AK, et al. Prediction of progression in Barrett's esophagus using a tissue systems pathology test: a pooled analysis of international multicenter studies. Clin Gastroenterol Hepatol. 2022;20(12):2772-2779.e8. doi:10.1016/j.cgh.2022.02.033 Davison JM, Goldblum JR, Duits LC, et al. A tissue systems pathology test outperforms the standard-of-care variables in predicting progression in patients with Barrett's esophagus. Clin Transl Gastroenterol. 2023;14(11):e00631. Published 2023 Nov 1. doi:10.14309/ctg.0000000000000631 Rubenstein JH, Sawas T, Wani S, et al. AGA clinical practice guideline on endoscopic eradication therapy of Barrett’s esophagus and related neoplasia. Gastroenterology. 2024;166(6):1020-1055. doi: 10.1053/j.gastro.2024.03.019 Muthusamy VR, Wani S, Gyawali CP, Komanduri S; CGIT Barrett’s Esophagus Consensus Conference Participants. AGA clinical practice update on new technology and innovation for surveillance and screening in Barrett's esophagus: Expert Review. Clin Gastroenterol Hepatol. 2022;20(12):2696-2706.e1. doi: 10.1016/j.cgh.2022.06.003

In collaboration with leading GI experts, Castle has also planned several educational sessions at DDW 2024, including a product theater and two American Society for Gastrointestinal Endoscopy (ASGE) theater talks FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share three abstracts supporting the ability of its TissueCypher® test to predict risk of progression to esophageal cancer in patients with Barrett’s esophagus (BE) at the Digestive Disease Week (DDW) 2024 Annual Meeting, being held May 18-21, 2024, in Washington, D.C. “We are committed to advancing care for patients with BE in an effort to reduce the incidence of esophageal cancer and importantly, to help save patients’ lives by informing earlier, potentially life-saving interventions,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “The data we are sharing at DDW 2024 in collaboration with renowned GI experts from the U.S. and abroad further expand the substantial clinical evidence supporting our TissueCypher test and its ability to improve the care that BE patients receive.” The following abstracts will be presented at DDW 2024 (all times Eastern Time). Abstracts will be available on the DDW ePosters site and to conference attendees in the DDW meeting planner and mobile app after 12:01 a.m. on Sunday, May 19, 2024. Podium presentation title: The Tissue Systems Pathology Test Enables Risk-Aligned Management for Patients with Barrett’s Esophagus Presenter and Lead Author: Lucas Duits, M.D., Ph.D., Amsterdam University Medical Centers Abstract #: 392 Session Type: Research Forum Session #: 3265 Session Title: Advances in Barrett's Esophagus Date & Time: Sunday, May 19, 11:15-11:30 a.m. Title: The Tissue Systems Pathology Test Predicts Risk of Malignant Progression in Patients with Barrett's Esophagus: A Systematic Review and Meta-Analysis Presenter and Lead Author: Ashley Tran, M.D., Keck School of Medicine, University of Southern California (USC) Abstract #: Su1266 Session Type: Poster Session Session #: 7110 Session Title: Barrett's Esophagus and Esophagogastric Junction Neoplasia - Epidemiology, Risk factors, Screening, Surveillance, Treatment and Outcomes Session Date & Time: Sunday, May 19, 12:30-1:30 p.m. Title: The Tissue Systems Pathology Test Provides Clinically Actionable Risk-Stratification in Patients with Barrett’s Esophagus: A Multicenter U.S. Clinical Experience Presenter and Lead Author: Harshit Khara, M.D. FACG, FASGE, Geisinger Health System Abstract #: Su1267 Session Type: Poster Session Session #: 7110 Session Title: Barrett's Esophagus and Esophagogastric Junction Neoplasia - Epidemiology, Risk factors, Screening, Surveillance, Treatment and Outcomes Session Date & Time: Sunday, May 19, 12:30-1:30 p.m. Visit Castle at DDW 2024 For more information on the above abstracts and the TissueCypher test, visit Castle at booth 3737; a complete list of Castle’s activities at DDW 2024 can be found at . Key events include the following: Product Theater BEyond the diagnosis: personalized, precision medicine in the management of Barrett’s esophagus Panel discussion to include: Emmanuel Gorospe, M.D., MPH, FACP, FACG, FASGE, GI medical director at Castle Biosciences; Dan Lister, M.D., FACS, FAFS, surgeon and director of the Arkansas Heartburn Treatment Center, and co-founder and president elect of the American Foregut Society; Dr. Farhan Quader, M.D., interventional gastroenterologist at NorthShore University Hospital in Chicago; Sarah Enslin, PA-C, Division of Gastroenterology and Hepatology at the University of Rochester Medical Center Rochester in New York Location: DDW Product Theater 1 Date & Time: Tuesday, May 21, 12-12:45 p.m. ASGE Theater Talks A modern approach to the clinical management of patients with Barrett’s esophagus Presenter: Harshit Khara, M.D., FACG, FASGE, Geisinger Medical Center Date & Time: Saturday, May 18, 10:15-10:45 a.m. Leveraging clinically impactful risk stratification for patients with Barrett’s esophagus Presenter: John C. Lipham, M.D., Keck Medicine of USC Date & Time: Monday, May 20, 2:45-3:15 p.m. Additionally, Castle is collaborating with several organizations, including the ASGE, Esophageal Cancer Action Network, American Muslim Gastroenterologist Network, American Foregut Society and Women in Endoscopy on various educational and networking events taking place throughout the meeting. About Digestive Disease Week® (DDW) Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at . 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 13 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, 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 and connect with us on LinkedIn, Facebook, X and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, 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: (i) Castle’s ability to advance care for patients with BE; and (ii) the ability of the TissueCypher test to predict the risk of progression to esophageal cancer in patients with BE and to help save patients’ lives by informing earlier, potentially life-saving interventions. 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, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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.