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Castle Biosciences分享新数据,证明TissueCypher®检测结果有能力为非发育不良Barrett食管患者的临床决策提供信息

Castle Biosciences Shares New Data Demonstrating Ability of TissueCypher® Test Results to Inform Clinical Decision-Making in Patients with Non-Dysplastic Barrett’s Esophagus

businesswire 等信源发布 2023-10-02 17:00

可切换为仅中文


FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data demonstrating the significant clinical utility of its TissueCypher® Barrett’s Esophagus test in guiding risk-aligned upstaging of care for patients with non-dysplastic Barrett’s esophagus (NDBE) at a higher risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) than indicated by their clinicopathologic risk factors..

德克萨斯州FRIENDSWOOD-(商业线)-Castle Biosciences,Inc.(纳斯达克股票代码:CSTL),一家通过创新测试改善健康状况的公司,指导患者护理,今天宣布了新的数据,证明其TissueCypher®Barrett食管试验在指导非发育不良Barrett食管(NDBE)患者进展为高度不典型增生(HGD)或食管的风险较高的风险调整升级护理方面具有重要的临床应用腺癌(EAC)比他们的临床病理危险因素所指示的要好。。

The data was presented in a poster at the recent American Foregut Society (AFS) Annual Meeting. The poster, titled “A Tissue Systems Pathology Test Enables Risk-Aligned Management of Patients with Non-Dysplastic Barrett’s Esophagus: Case Reports from a Gastrointestinal Surgery Center,” can be viewed here..

数据在最近的美国前肠协会(AFS)年会上以海报的形式呈现。可以在这里查看名为“组织系统病理学测试可对非增生性Barrett食管患者进行风险对齐管理:胃肠外科中心的病例报告”的海报。。

'In the management of BE, there are several therapeutic strategies to help prevent the development of esophageal cancer,” said Daniel Tseng, M.D., F.A.C.S., surgeon at Northwest Minimally Invasive Surgery Center in Portland, Oregon, and lead author of the study. “These options include endoscopic eradication therapies (EET) such as radiofrequency ablation (RFA) or cryoablation, as well as anti-reflux surgery that can stop chronic injury to the esophagus..

“在BE的管理中,有几种治疗策略可以帮助预防食道癌的发展,”俄勒冈州波特兰西北微创外科中心的外科医生Daniel Tseng博士,F.A.C.S.和该研究的主要作者说。“这些选择包括内镜根除治疗(EET),如射频消融(RFA)或冷冻消融,以及可以阻止食管慢性损伤的抗反流手术。。

“The challenge arises in predicting which patients in the large pool of those with NDBE are most likely to progress and could thus benefit from these treatments early, when they are most effective. These case studies support the use of TissueCypher to potentially identify which NDBE patients are at a higher risk of disease progression and should be managed accordingly.”.

“挑战在于预测NDBE患者中大量患者中哪些患者最有可能进展,因此可以在最有效时尽早从这些治疗中受益。这些案例研究支持使用TissueCypher潜在地识别哪些NDBE患者疾病进展风险较高,应予以相应管理“。

The overall population of patients with NDBE are considered to be at low risk for progression based on their clinicopathologic risk factors. However, the high incidence of NDBE indicates that at least half of the patients who progress to HGD/EAC annually are diagnosed as NDBE and can be missed by current clinicopathologic-based risk stratification and therefore, undertreated.

根据其临床病理危险因素,NDBE患者的总体人群被认为进展风险较低。然而,NDBE的高发病率表明,每年至少有一半进展为HGD/EAC的患者被诊断为NDBE,并且可能被当前基于临床病理学的风险分层所遗漏,因此未得到充分治疗。

The case study reinforced the ability of TissueCypher to identify NDBE patients at high/intermediate risk for progression to HGD/EAC. The patients in the case study had predicted 5-year risk of progression to HGD/EAC that was similar (range 6-14%) to the published estimates of progression in patients with confirmed low-grade dysplasia (LGD) (8.5%), a pathologic diagnosis associated with higher progression risk for which guidelines recommend EET, such as RFA.

该案例研究增强了TissueCypher识别进展为HGD/EAC的高/中等风险的NDBE患者的能力。案例研究中的患者预测5年进展为HGD/EAC的风险与已确诊的低度不典型增生(LGD)患者的进展估计值(8.5%)相似(范围6-14%),病理诊断与更高的进展风险相关,指南推荐EET,如RFA。

Identification of NDBE patients with similar progression risk to LGD enables physicians and their patients to consider risk-aligned upstaging of care to prevent development of EAC and improve their overall health outcomes..

鉴定具有与LGD相似的进展风险的NDBE患者,可以使医生及其患者考虑与风险相一致的护理升级,以防止EAC的发展并改善其整体健康状况。。

About TissueCypher® Barrett’s Esophagus Test

关于TissueCypher®Barrett食管测试

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 12 peer-reviewed publications of BE progressor patients with leading clinical centers around the world.

TissueCypher Barrett食管测试是Castle的精确药物测试,旨在预测Barrett食管(BE)患者高度不典型增生(HGD)和/或食管癌的未来发展。TissueCypher-Barrett食管试验适用于经内镜活检证实为非发育不良(NDBE),不确定发育不良(IND)或低度不典型增生(LGD)的患者;其临床表现得到了全球领先临床中心的BE进展患者的12篇同行评审出版物的支持。

The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022..

该测试于2022年3月从医疗保险和医疗补助服务中心(CMS)获得了高级诊断实验室测试(ADLT)状态。。

About Castle Biosciences

关于城堡生物科学

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 Biosciences(纳斯达克股票代码:CSTL)是一家领先的诊断公司,通过创新测试改善健康状况,指导患者护理。本公司旨在通过让人首先:患者,临床医生,员工和投资者来改变疾病管理。

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.

Castle目前的产品组合包括皮肤癌,葡萄膜黑色素瘤,Barrett食道和心理健康状况的测试。此外,该公司还积极开展临床需求较高的其他疾病检测研究和开发项目,包括开发中的检测,以预测中重度银屑病,特应性皮炎及相关疾病患者的全身治疗反应。

To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram..

要了解更多信息,请访问www.CastleBiosciences.com并通过LinkedIn,Facebook,X和Instagram与我们联系。。

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

DecisionDx黑色素瘤,DecisionDx CMSeq,DecisionDx SCC,MyPath黑色素瘤,DecisionDx UM,DecisionDx PRAME,DecisionDx UMSeq,TissueCypher和IDgenetix是Castle Biosciences,Inc.的商标。

Forward-Looking Statements

前瞻性声明

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 identify which NDBE patients are at a higher risk of disease progression and should be managed accordingly.

本新闻稿包含1933年“证券法”第27A条(经修订)和1934年“证券交易所法”第21E条(经修订)含义内的前瞻性声明,这些声明受所创建的“安全港”的约束。部分。这些前瞻性陈述包括但不限于以下陈述:TissueCypher有可能确定哪些NDBE患者疾病进展风险较高,应予以相应管理。

The words “can,” “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.

“可以”,“潜在”和类似表达式旨在标识前瞻性语句,尽管并非所有前瞻性语句都包含这些标识词。我们实际上可能无法实现我们前瞻性声明中披露的计划,意图或期望,您不应过分依赖我们的前瞻性声明。

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 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, and in our other filings with the SEC.

实际结果或事件可能与我们制定的前瞻性声明中披露的计划,意图和期望有很大不同。这些前瞻性陈述涉及可能导致我们的实际结果与前瞻性陈述中的实际结果大不相同的风险和不确定性,包括但不限于:随后的研究或试验结果和结果可能与先前的研究或试验结果和结果相矛盾或可能不支持本研究显示的结果,包括关于本新闻稿中TissueCypher®Barrett食管试验的讨论;我们的测试的实际应用可能不会为患者提供上述益处;以及我们在2022年12月31日结束的年度10-K年度报告中的“风险因素”标题下以及我们与SEC的其他文件中提出的风险。

The forward-looking statements are applicable only as of the date.

前瞻性声明仅适用于日期。