在多项已发表的研究中，该测试始终能够识别出其进展速度超过基于指南的强化护理可采取行动阈值的高风险患者
德克萨斯州弗伦斯伍德，2025 年 12 月 12 日（GLOBE NEWSWIRE）-- Castle Biosciences, Inc.（纳斯达克：CSTL），一家通过创新测试改善健康以指导患者护理的公司，今天宣布发表了一项新的系统评价和荟萃分析（SRMA），证明 TissueCypher®巴雷特食管测试为巴雷特食管（BE）患者提供了临床验证的风险分层。研究结果确认，TissueCypher 能够超越传统病理或临床因素，识别出有更高风险发展为食管癌的患者。
该论文题为 “组织系统病理测试预测巴雷特食管患者进展风险：系统评价和荟萃分析”，发表在《临床胃肠病学杂志》上。分析整合了六项已发表研究的数据，发现 TissueCypher 始终能够识别出更有可能进展为高等级上皮内瘤变（HGD）或食管腺癌（EAC）的患者，这是实现个性化、风险对齐患者管理以预防癌症的关键步骤。
“我们的研究结果提供了强有力的证据，表明 TissueCypher 为巴雷特食管患者提供了有意义的风险分层，” 加州洛杉矶南加州大学 Keck 医学中心的董事会认证前胃外科医生、研究的主要作者 Caitlin C. Houghton 博士表示。“通过识别哪些患者真正处于高风险进展为食管癌的状态——以及哪些不是——TissueCypher 可以帮助医生个性化护理，标记出那些可能受益于早期干预的患者，并为那些低风险患者继续常规监测提供信心。”
SRMA 代表了临床验证的严格高质量证据，因为它们整合了多项研究的发现，以提供整体性能估计。这项 SRMA 的结果代表了迄今为止对 TissueCypher 测试的最全面验证，强化了其作为基于证据的巴雷特食管风险分层工具的价值。研究表明，TissueCypher 在非上皮内瘤变（NDBE）、不确定上皮内瘤变（IND）和低等级上皮内瘤变（LGD）患者中的预测性能，并显示该测试在识别出最有可能进展的患者方面优于组织学评估。
SRMA 的关键发现表明 TissueCypher 可以帮助医生：
<ul>
<li>识别最高风险患者： 在六项已发表的研究中，具有高风险 TissueCypher 结果的患者在五年内进展为 HGD 或 EAC 的可能性是低风险结果患者的 6.7 倍（p&lt;0.0001）。</li>
<li>自信地指导护理： 高风险或中等风险结果的患者年进展率为 2.8%，而高风险结果的患者年进展率为 5.6%，均高于通常报告的 LGD 患者的 1.7% 年进展率，这是治疗干预的临床基准。</li>
</ul>
通过整合多项研究的数据，这项分析确认了 TissueCypher 提供一致、可重复的性能，并支持其帮助医生提供风险对齐护理的潜力，识别出最有可能进展的患者，并量身定制管理策略，以改善结果，同时减少不必要的程序。
关于 TissueCypher 巴雷特食管测试
TissueCypher 是一种精准医学测试，经过广泛验证，旨在预测患者从巴雷特食管进展到高等级上皮内瘤变或食管腺癌的个性化风险。适用于非上皮内瘤变 BE、不确定上皮内瘤变或低等级上皮内瘤变的患者，TissueCypher 的五年风险评估旨在帮助医生根据每位患者发展 HGD 或 EAC 的风险量身定制护理。
TissueCypher 得到了 17 篇同行评审的出版物的支持，并在超过 8000 名患者的活检中进行了研究，已被证明是与传统组织病理风险评估相比，进展的最强独立预测因子。该测试采用基于 AI 的空间组学方法，识别出通常在上皮内瘤变发展之前出现的分子特征，这可以实现对高风险癌症患者的早期识别、治疗和管理。TissueCypher 旨在通过分析标准的食管夹取活检，顺利融入常规内镜实践，提供可操作的见解，而无需额外的程序。了解更多信息，请访问 www.CastleBiosciences.com/TissueCypher。
关于 Castle Biosciences
Castle Biosciences（纳斯达克：CSTL）是一家领先的诊断公司，通过创新测试改善健康，以指导患者护理。我们主要关注皮肤病和胃肠疾病，开发个性化、临床可操作的解决方案，以帮助改善疾病管理和患者结果。
我们以人为本——赋能患者和临床医生，通过严格的科学和先进的分子测试来支持更自信的治疗规划。要了解更多信息，请访问 www.CastleBiosciences.com，并在 LinkedIn、Instagram、Facebook 和 X 上与我们联系。
DecisionDx-Melanoma、DecisionDx-CM Seq、i31-SLNB、i31-ROR、DecisionDx-SCC、MyPath Melanoma、AdvanceAD-Tx、TissueCypher、DecisionDx-UM、DecisionDx-PRAME 和 DecisionDx-UM _Seq_是 Castle Biosciences, Inc.的商标。
前瞻性声明
本新闻稿包含根据《1933 年证券法》第 27A 条和《1934 年证券交易法》第 21E 条的定义的前瞻性声明，这些声明受这些条款所创建的 “安全港” 保护。这些前瞻性声明包括但不限于关于：TissueCypher 在提供超越病理或临床因素的风险洞察能力方面的能力，以及为 BE 患者提供更个性化的监测和治疗策略，这可能有助于预防癌症，包括支持对那些有较高进展至食道癌风险的患者进行早期干预，减少对那些进展风险较低的患者的不必要程序，并支持对发现有不确定性发育不良的患者进行风险对齐管理。“相信”、“可能”、“可以” 等类似表达旨在识别前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词。我们可能无法实际实现我们在前瞻性声明中披露的计划、意图或期望，因此您不应对我们的前瞻性声明过度依赖。实际结果或事件可能与我们在前瞻性声明中披露的计划、意图和期望有实质性差异。这些前瞻性声明涉及风险和不确定性，可能导致我们的实际结果与前瞻性声明中的结果有实质性差异，包括但不限于：后续研究或试验结果和发现可能与早期研究或试验结果和发现相矛盾，或可能不支持这些研究中获得的结果，包括关于我们在本新闻稿中讨论的测试；我们测试的实际应用可能无法为患者提供上述好处；以及在我们向 SEC 提交的截至 2024 年 12 月 31 日的年度报告 10-K 和截至 2025 年 9 月 30 日的季度报告 10-Q 中列出的 “风险因素” 标题下列出的风险，以及我们向 SEC 提交的其他文件。前瞻性声明仅适用于声明发布之日，我们不承担更新任何前瞻性声明的义务，除非法律要求。
投资者联系：
Camilla Zuckero
czuckero@castlebiosciences.com
媒体联系：
Allison Marshall
amarshall@castlebiosciences.com
来源： Castle Biosciences, Inc.
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CSTL

Castle Biosciences 宣布了一项系统评价和荟萃分析，确认了 TissueCypher 在识别高风险巴雷特食管患者方面的有效性。该测试优于传统病理学，有助于个性化护理和早期干预。研究发表在《临床胃肠病学杂志》上，整合了六项研究的数据，显示高风险患者发展为食管癌的可能性是普通患者的 6.7 倍。TissueCypher 的人工智能驱动方法提供了一致、可重复的表现，支持与风险相匹配的患者管理

Across multiple published studies, the test consistently identifies high-risk patients whose progression rates exceed guideline-based actionable thresholds for intensified care
<div class="lb-trans">在多项已发表的研究中，该测试始终能够识别出其进展速度超过基于指南的强化护理可采取行动阈值的高风险患者
</div>FRIENDSWOOD, Texas, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a new systematic review and meta-analysis (SRMA) demonstrating that the TissueCypher® Barrett’s Esophagus test provides clinically validated risk stratification for patients with Barrett’s esophagus (BE). The findings confirm that TissueCypher can outperform traditional pathology or clinical factors alone to identify patients at increased risk of developing esophageal cancer.
<div class="lb-trans">德克萨斯州弗伦斯伍德，2025 年 12 月 12 日（GLOBE NEWSWIRE）-- Castle Biosciences, Inc.（纳斯达克：CSTL），一家通过创新测试改善健康以指导患者护理的公司，今天宣布发表了一项新的系统评价和荟萃分析（SRMA），证明 TissueCypher®巴雷特食管测试为巴雷特食管（BE）患者提供了临床验证的风险分层。研究结果确认，TissueCypher 能够超越传统病理或临床因素，识别出有更高风险发展为食管癌的患者。
</div>The paper, titled “The Tissue Systems Pathology Test Predicts Risk of Progression in Patients With Barrett’s Esophagus: Systematic Review and Meta-Analysis,” was published in the Journal of Clinical Gastroenterology. The analysis consolidated data from six previously published studies and found that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC), a key step toward enabling personalized, risk-aligned patient management aimed at preventing cancer.
<div class="lb-trans">该论文题为 “组织系统病理测试预测巴雷特食管患者进展风险：系统评价和荟萃分析”，发表在《临床胃肠病学杂志》上。分析整合了六项已发表研究的数据，发现 TissueCypher 始终能够识别出更有可能进展为高等级上皮内瘤变（HGD）或食管腺癌（EAC）的患者，这是实现个性化、风险对齐患者管理以预防癌症的关键步骤。
</div>“Our findings provide strong evidence that TissueCypher delivers meaningful risk stratification for patients with Barrett’s esophagus,” said Caitlin C. Houghton, M.D., board-certified foregut surgeon at Keck Medicine of USC in Los Angeles, California, and lead author of the study. “By identifying which patients are truly at high risk for progression to esophageal cancer — and which are not — TissueCypher can help physicians personalize care, flagging those who may benefit from earlier intervention and providing confidence in continuing routine surveillance for those at low risk.”
<div class="lb-trans">“我们的研究结果提供了强有力的证据，表明 TissueCypher 为巴雷特食管患者提供了有意义的风险分层，” 加州洛杉矶南加州大学 Keck 医学中心的董事会认证前胃外科医生、研究的主要作者 Caitlin C. Houghton 博士表示。“通过识别哪些患者真正处于高风险进展为食管癌的状态——以及哪些不是——TissueCypher 可以帮助医生个性化护理，标记出那些可能受益于早期干预的患者，并为那些低风险患者继续常规监测提供信心。”
</div>SRMAs represent rigorous, high-quality evidence for clinical validation because they synthesize findings across multiple studies to provide overall estimates of performance. The results of this SRMA represent the most comprehensive validation of the TissueCypher test to date, reinforcing its value as an evidence-based tool for risk stratification in BE. The study demonstrates TissueCypher’s predictive performance across patients with non-dysplastic BE (NDBE), indefinite for dysplasia (IND) and low-grade dysplasia (LGD), and shows that the test outperforms histologic assessment in identifying patients at greatest risk of progression.
<div class="lb-trans">SRMA 代表了临床验证的严格高质量证据，因为它们整合了多项研究的发现，以提供整体性能估计。这项 SRMA 的结果代表了迄今为止对 TissueCypher 测试的最全面验证，强化了其作为基于证据的巴雷特食管风险分层工具的价值。研究表明，TissueCypher 在非上皮内瘤变（NDBE）、不确定上皮内瘤变（IND）和低等级上皮内瘤变（LGD）患者中的预测性能，并显示该测试在识别出最有可能进展的患者方面优于组织学评估。
</div>Key findings of the SRMA indicate TissueCypher can help physicians:
<div class="lb-trans">SRMA 的关键发现表明 TissueCypher 可以帮助医生：
</div><ul>
<li>Identify patients at highest risk: Across six published studies, patients with high-risk TissueCypher results were 6.7 times more likely to progress to HGD or EAC within five years than those with low-risk results (p&lt;0.0001).</li>
<li>Guide care with confidence: Patients with high or intermediate-risk results had an annual progression rate of 2.8%, and those with high-risk results had a rate of 5.6% per year, both above the 1.7% annual progression rate typically reported for patients with LGD, a clinical benchmark for therapeutic intervention.</li>
</ul>
<div class="lb-trans"><ul>
<li>识别最高风险患者： 在六项已发表的研究中，具有高风险 TissueCypher 结果的患者在五年内进展为 HGD 或 EAC 的可能性是低风险结果患者的 6.7 倍（p&lt;0.0001）。</li>
<li>自信地指导护理： 高风险或中等风险结果的患者年进展率为 2.8%，而高风险结果的患者年进展率为 5.6%，均高于通常报告的 LGD 患者的 1.7% 年进展率，这是治疗干预的临床基准。</li>
</ul>
</div>By integrating data across multiple studies, this analysis confirms that TissueCypher provides consistent, reproducible performance and supports its potential to help physicians deliver risk-aligned care, identifying patients most likely to progress and tailoring management strategies that can improve outcomes while reducing unnecessary procedures.
<div class="lb-trans">通过整合多项研究的数据，这项分析确认了 TissueCypher 提供一致、可重复的性能，并支持其帮助医生提供风险对齐护理的潜力，识别出最有可能进展的患者，并量身定制管理策略，以改善结果，同时减少不必要的程序。
</div>About TissueCypher Barrett’s Esophagus Test
<div class="lb-trans">关于 TissueCypher 巴雷特食管测试
</div>TissueCypher is a precision medicine test designed and extensively validated to predict a patient’s personalized risk of progression from Barrett’s esophagus to high-grade dysplasia or esophageal adenocarcinoma. Indicated for patients with non-dysplastic BE, indefinite for dysplasia or with low-grade dysplasia, TissueCypher’s five-year risk assessment is designed to help physicians tailor care to each patient’s risk of developing HGD or EAC.
<div class="lb-trans">TissueCypher 是一种精准医学测试，经过广泛验证，旨在预测患者从巴雷特食管进展到高等级上皮内瘤变或食管腺癌的个性化风险。适用于非上皮内瘤变 BE、不确定上皮内瘤变或低等级上皮内瘤变的患者，TissueCypher 的五年风险评估旨在帮助医生根据每位患者发展 HGD 或 EAC 的风险量身定制护理。
</div>Backed by 17 peer-reviewed publications and studied in biopsies from more than 8,000 patients, TissueCypher has been shown to be the strongest independent predictor of progression compared with traditional histopathological risk assessment. Using an AI-driven spatialomics approach, the test identifies molecular signatures that often precede the development of dysplasia, which can enable earlier identification, treatment, and management of patients at increased risk of cancer. TissueCypher is designed to integrate seamlessly into routine endoscopic practice by analyzing standard esophageal pinch biopsies, delivering actionable insights without requiring additional procedures. Learn more at www.CastleBiosciences.com/TissueCypher.
<div class="lb-trans">TissueCypher 得到了 17 篇同行评审的出版物的支持，并在超过 8000 名患者的活检中进行了研究，已被证明是与传统组织病理风险评估相比，进展的最强独立预测因子。该测试采用基于 AI 的空间组学方法，识别出通常在上皮内瘤变发展之前出现的分子特征，这可以实现对高风险癌症患者的早期识别、治疗和管理。TissueCypher 旨在通过分析标准的食管夹取活检，顺利融入常规内镜实践，提供可操作的见解，而无需额外的程序。了解更多信息，请访问 www.CastleBiosciences.com/TissueCypher。
</div>About Castle Biosciences
<div class="lb-trans">关于 Castle Biosciences
</div>Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes.
<div class="lb-trans">Castle Biosciences（纳斯达克：CSTL）是一家领先的诊断公司，通过创新测试改善健康，以指导患者护理。我们主要关注皮肤病和胃肠疾病，开发个性化、临床可操作的解决方案，以帮助改善疾病管理和患者结果。
</div>We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Instagram, Facebook and X.
<div class="lb-trans">我们以人为本——赋能患者和临床医生，通过严格的科学和先进的分子测试来支持更自信的治疗规划。要了解更多信息，请访问 www.CastleBiosciences.com，并在 LinkedIn、Instagram、Facebook 和 X 上与我们联系。
</div>DecisionDx-Melanoma, DecisionDx-CM Seq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq are trademarks of Castle Biosciences, Inc.
<div class="lb-trans">DecisionDx-Melanoma、DecisionDx-CM Seq、i31-SLNB、i31-ROR、DecisionDx-SCC、MyPath Melanoma、AdvanceAD-Tx、TissueCypher、DecisionDx-UM、DecisionDx-PRAME 和 DecisionDx-UM _Seq_是 Castle Biosciences, Inc.的商标。
</div>Forward-Looking Statements
<div class="lb-trans">前瞻性声明
</div>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 ability to provide risk insights beyond pathology or clinical factors alone and enable more personalized surveillance and treatment strategies for BE patients that may help prevent cancer, including supporting earlier intervention for those at higher risk for progression to esophageal cancer, reducing unnecessary procedures for those at lower risk of progression, and supporting risk-aligned management of patients with a finding of indefinite for dysplasia. The words “believe,” “may,” “can” 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 obtained in these studies, including with respect to the discussion of our tests 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, 2024, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each as filed with the SEC, 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.
<div class="lb-trans">本新闻稿包含根据《1933 年证券法》第 27A 条和《1934 年证券交易法》第 21E 条的定义的前瞻性声明，这些声明受这些条款所创建的 “安全港” 保护。这些前瞻性声明包括但不限于关于：TissueCypher 在提供超越病理或临床因素的风险洞察能力方面的能力，以及为 BE 患者提供更个性化的监测和治疗策略，这可能有助于预防癌症，包括支持对那些有较高进展至食道癌风险的患者进行早期干预，减少对那些进展风险较低的患者的不必要程序，并支持对发现有不确定性发育不良的患者进行风险对齐管理。“相信”、“可能”、“可以” 等类似表达旨在识别前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词。我们可能无法实际实现我们在前瞻性声明中披露的计划、意图或期望，因此您不应对我们的前瞻性声明过度依赖。实际结果或事件可能与我们在前瞻性声明中披露的计划、意图和期望有实质性差异。这些前瞻性声明涉及风险和不确定性，可能导致我们的实际结果与前瞻性声明中的结果有实质性差异，包括但不限于：后续研究或试验结果和发现可能与早期研究或试验结果和发现相矛盾，或可能不支持这些研究中获得的结果，包括关于我们在本新闻稿中讨论的测试；我们测试的实际应用可能无法为患者提供上述好处；以及在我们向 SEC 提交的截至 2024 年 12 月 31 日的年度报告 10-K 和截至 2025 年 9 月 30 日的季度报告 10-Q 中列出的 “风险因素” 标题下列出的风险，以及我们向 SEC 提交的其他文件。前瞻性声明仅适用于声明发布之日，我们不承担更新任何前瞻性声明的义务，除非法律要求。
</div>Investor Contact:
<div class="lb-trans">投资者联系：
</div>Camilla Zuckero
<div class="lb-trans">Camilla Zuckero
</div>czuckero@castlebiosciences.com
<div class="lb-trans">czuckero@castlebiosciences.com
</div>Media Contact:
<div class="lb-trans">媒体联系：
</div>Allison Marshall
<div class="lb-trans">Allison Marshall
</div>amarshall@castlebiosciences.com
<div class="lb-trans">amarshall@castlebiosciences.com
</div>Source: Castle Biosciences, Inc.
<div class="lb-trans">来源： Castle Biosciences, Inc.
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Systematic Review and Meta-Analysis Confirms TissueCypher® Outperforms Traditional Pathology or Clinical Factors Alone to Identify Patients at Increased Risk of Developing Esophageal Cancer | CSTL Stock News

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