Freenome宣布《美国医学会杂志》发布其基于血液的结直肠癌检测关键研究数据-动脉网

Freenome Announces JAMA Publication of Data from Pivotal Study of its Bloodased Test for Colorectal Cancer

CISION 等信源发布 2025-06-03 01:25



可切换为仅中文







– PREEMPT CRC, the largest prospective study of its kind, met all primary efficacy endpoints and

PREEMPT CRC，同类研究中规模最大的前瞻性研究，达到了所有主要疗效终点

surpassed CMS coverage requirements for sensitivity and specificity in the intended use population –

超过了CMS在预期使用人群中的灵敏度和特异性覆盖要求 –

– FDA premarket approval submission is underway, with

– FDA的上市前审批提交正在进行中，

completion anticipated mid-2025 –

预计2025年年中完成 -

BRISBANE, Calif.

布里斯班，加利福尼亚州

，

June 2, 2025

2025年6月2日

/PRNewswire/ -- Freenome, a biotechnology company pioneering an early cancer detection platform, today announced the publication of detailed results from the pivotal PREEMPT CRC study in JAMA.

/PRNewswire/ -- 开创早期癌症检测平台的生物技术公司 Freenome 今天宣布，在《美国医学会杂志》(JAMA) 上发表了关键的 PREEMPT CRC 研究的详细结果。

The publication presents findings from the largest prospective study of a blood-based screening test for colorectal cancer (CRC), involving 48,995 average-risk adults aged 45 to 85 who underwent a routine colonoscopy following a blood draw.

该出版物介绍了针对结直肠癌（CRC）的血液筛查测试的最大规模前瞻性研究结果，研究涉及48,995名年龄在45至85岁之间的平均风险成年人，他们在抽血后接受了常规结肠镜检查。

Based on data from the 27,010 eligible participants who enrolled consecutively in the study after a predetermined cut-off date, the test met all prespecified primary acceptance criteria. The publication also includes a pre-specified analysis that weighted test performance to match the sex and age distribution of the U.S.

基于在预设截止日期之后连续参加研究的 27,010 名符合条件的参与者的数据，该测试达到了所有预先设定的主要接受标准。该出版物还包括一项预先设定的分析，该分析对测试性能进行了加权，以匹配美国的性别和年龄分布。

population, a method used by the U.S. Food and Drug Administration (FDA) for other CRC screening products..

人群，美国食品和药物管理局（FDA）用于其他结直肠癌筛查产品的方法。

Metric

度量标准

Primary Analysis

主要分析

U.S. Census-Adjusted

美国人口普查调整

Overall CRC sensitivity

总体CRC灵敏度

79.2 %

81.1% (100%: ages 45-49)

81.1%（100%：45-49岁）

Stage-specific sensitivity

阶段特异性敏感性

● Stage I

● 第一阶段

57.1 %

63.5 %

● Stage II

● 第二阶段

100 %

● Stage III

● 第三阶段

82.4 %

80.5 %

● Stage IV

● 第四阶段

100 %

Specificity: Advanced colorectal neoplasia (ACN)

特异性：晚期结直肠肿瘤（ACN）

91.5 %

90.4 %

Advanced precancerous lesions (APL)

高级癌前病变 (APL)

sensitivity

敏感性

12.5 %

13.7 %

High-grade dysplasia and carcinoma in situ

高级别不典型增生和原位癌

sensitivity

敏感性

29.1 %

30.5%

Online Supplement:1-19

在线补充：1-19

Data on file

数据存档

Designated as Stage 0 cancer by the American Cancer Society

被美国癌症协会指定为0期癌症

'Despite clear guidelines, many communities still face barriers that lead to fewer people getting screened for colorectal cancer,' said

“尽管有明确的指导方针，许多社区仍然面临障碍，导致接受结直肠癌筛查的人数减少，”

Aasma Shaukat

阿萨玛·肖卡特

, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study. 'The study's rigor and scale provide confidence in the test's performance. Its high sensitivity means it can detect most cancers, while high specificity helps avoid false alarms.

医学博士、公共卫生硕士、纽约大学格罗斯曼医学院医学教授、PREEMPT CRC 研究的共同首席研究员。“该研究的严谨性和规模为测试性能提供了信心。其高灵敏度意味着可以检测到大多数癌症，而高特异性有助于避免误报。”

Both are critical to making screening effective and efficient, as well as easier for patients and providers.'.

两者对于使筛查有效、高效以及让患者和提供者更方便都至关重要。

More than two out of five U.S. adults of screening age are not current with recommended CRC screening. Barriers such as discomfort, preparation or access often lead to low adoption rates. Importantly, among adults aged 45–49, who are newly recommended for screening and of whom only 20% are up to date, the test showed 100% sensitivity for CRC and 94.8% specificity for ACN in the primary analysis..

超过五分之二的美国适龄成年人未按照推荐进行结直肠癌（CRC）筛查。诸如不适感、准备工作或获取途径等障碍常常导致筛查采纳率较低。重要的是，在45-49岁这一新被建议进行筛查的人群中，只有20%的人及时进行了筛查，而该测试在初步分析中显示出对结直肠癌100%的敏感性和对晚期癌前病变（ACN）94.8%的特异性。

'By enrolling a diverse, average-risk population and analyzing samples consecutively, the PREEMPT study mirrored real-world use,' said

“通过注册一个多样化、平均风险的人群并连续分析样本，PREEMPT研究反映了真实世界的使用情况，”

Aaron Elliott

艾伦·埃利奥特

, Ph.D., chief executive officer at Freenome. 'The test showed strong performance in Stage I cancer and high-risk pre-cancers and among younger adults, compared to FDA-approved CRC blood tests. This highlights the potential of the Freenome test to expand adherence to CRC screening recommendations and detect cancer earlier.'.

弗里诺姆公司首席执行官博士表示：“该测试在一期癌症和高风险癌前病变以及年轻成人中表现出强劲的性能，相较于FDA批准的结直肠癌血液测试。这突显了弗里诺姆测试在扩大结直肠癌筛查建议的依从性以及及早发现癌症方面的潜力。”

PREEMPT CRC was conducted at more than 200 clinical sites using a hybrid recruitment strategy with the end goal of increasing trial accessibility and diversity. This approach made participation possible from every state in the continental U.S. More than 11% of participants identified as Black or African American, and over 11% as Hispanic or Latino..

PREEMPT CRC 在 200 多个临床试验基地进行，采用了混合招募策略，最终目标是提高试验的可及性和多样性。这种方法使得美国本土每个州的患者都有机会参与。超过 11% 的参与者为黑人或非裔美国人，超过 11% 的参与者为西班牙裔或拉丁裔。

'We need more tools that meet people where they are, which includes offering noninvasive screening options that are simple to complete,' Dr. Shaukat added. 'This test has the potential to increase screening uptake, especially among people who might otherwise delay or avoid screening.'

“我们需要更多能够满足人们需求的工具，其中包括提供简单易行的非侵入性筛查选项，”邵卡特博士补充道。“这项测试有可能提高筛查的接受度，特别是对于那些可能会延迟或避免筛查的人群。”

To pursue its vision of personalized early cancer detection, Freenome developed a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers to detect cancer-specific signals in the bloodstream, including those derived from circulating tumor DNA (ctDNA). The company's CRC screening blood test was built on this platform and applies an AI/ML-based model to detect specific methylation signatures in ctDNA at a base level.

为了实现其个性化早期癌症检测的愿景，Freenome开发了一个多组学平台，该平台通过分析基因组、表观基因组和蛋白质组学生物标志物来检测血液中的癌症特异性信号，包括那些来自循环肿瘤DNA（ctDNA）的信号。该公司基于这一平台构建了结直肠癌（CRC）筛查血液测试，并应用基于人工智能/机器学习（AI/ML）的模型，在碱基水平上检测ctDNA中的特定甲基化特征。

Designed for use with a standard blood draw, the test integrates into routine clinical workflows, leveraging Freenome's software..

该测试旨在与标准血液采集一起使用，整合到常规临床工作流程中，利用Freenome的软件。

The company is advancing the premarket approval submission for its CRC screening blood test to the FDA, with all modules expected to be completed in mid-2025. Freenome also continues to advance a test versioning strategy focused on assay and algorithm improvements to enhance CRC and APL detection, as well as pursue expansion into additional indications, including lung cancer..

公司正积极推进其结直肠癌（CRC）筛查血液检测的上市前批准申请提交至FDA，所有模块预计将在2025年年中完成。Freenome还继续推进一项测试版本策略，专注于检测方法和算法的改进，以提升CRC和APL的检测能力，并寻求扩展到其他适应症，包括肺癌。

The full manuscript is now available online in JAMA. To access the paper, visit

完整的手稿现已在JAMA在线提供。要访问该论文，请访问

https://jamanetwork.com/journals/jama/article-abstract/2834891

。

About PREEMPT CRC

关于PREEMPT CRC

PREEMPT CRC (

抢占 CRC (

NCT04369053

) was a prospective, registrational clinical study designed to validate Freenome's blood test for the early detection of colorectal cancer (CRC) among average-risk adults. Initiated in 2020, the study was conducted at more than 200 sites and enrolled 48,995 asymptomatic, average-risk participants between the ages of 45 and 85 scheduled to undergo a screening colonoscopy.

是一项前瞻性、注册性临床研究，旨在验证Freenome的血液检测方法在普通风险成年人群中早期发现结直肠癌（CRC）的效果。该研究于2020年启动，在200多个地点进行，招募了48,995名年龄在45至85岁之间、无症状且具有平均风险的参与者，这些参与者计划接受筛查性结肠镜检查。

Freenome and the U.S. Food and Drug Administration agreed upon a predetermined cut-off date for the period most affected by the COVID-19 pandemic. The study analyzed the 27,010 participants who enrolled consecutively or after the predetermined cut-off date..

Freenome 与美国食品药品监督管理局 (FDA) 就新冠疫情影响最严重的时期商定了一个预定的截止日期。该研究分析了在截止日期之后连续或陆续入组的 27,010 名参与者。

The study leveraged a novel hybrid model involving virtual and traditional recruitment methods to reach underserved communities and ensure a representative population. The

该研究利用了一种涉及虚拟和传统招聘方法的新型混合模式，以覆盖服务不足的社区并确保具有代表性的人口。

decentralized

去中心化的

recruitment strategy underscores Freenome's commitment to promoting equity and diversity in clinical studies, ensuring its tests are designed for everyone.

招聘策略强调了Freenome致力于在临床研究中促进公平和多样性，确保其测试设计适用于所有人。

Freenome's partners in PREEMPT CRC included the Colorectal Cancer Alliance, Dia de la Mujer Latina, the Intercultural Center for Health Research and Wellness, and historically Black colleges and universities (HBCUs), including

Freenome在PREEMPT CRC中的合作伙伴包括结直肠癌联盟、拉丁女性日、跨文化健康研究与保健中心，以及历史上黑人大学和学院（HBCUs），其中包括

Morehouse School of Medicine

莫尔豪斯医学院

. Freenome also worked with CVS Health Clinical Trial Services to help drive study enrollment through coordinated communication efforts targeting patients with already scheduled colonoscopies.

.Freenome还与CVS Health临床试验服务部门合作，通过针对已安排结肠镜检查的患者进行协调沟通，来帮助推动研究的注册工作。

About Freenome

关于Freenome

Freenome is breaking barriers to early cancer detection with a suite of blood tests built on its multiomics platform. The company recognizes that no single technology can identify every cancer due to the disease's inherent heterogeneity. Freenome's multimodal approach combines molecular biology and assays with computational biology, machine learning and multiple data types to tune into cancer's subtlest cues, even at the earliest stages of the disease..

Freenome正在通过其多组学平台开发的一系列血液检测技术，打破早期癌症检测的障碍。该公司认识到，由于癌症本身具有异质性，没有任何单一技术能够识别所有癌症。Freenome的多模式方法结合了分子生物学、检测技术、计算生物学、机器学习和多种数据类型，以捕捉癌症最微弱的信号，即使在疾病的最早阶段也不例外。

With the convenience of a standard blood draw, Freenome aims to empower everyone to access recommended cancer screenings. The company is partnering with healthcare organizations and population health decision-makers to integrate its technology and software platform, making cancer detection easier and more accessible.

通过标准抽血的便利性，Freenome旨在让每个人都能获得推荐的癌症筛查。该公司正与医疗保健组织和人口健康决策者合作，整合其技术和软件平台，使癌症检测变得更加容易和便捷。

Freenome is headquartered in .

Freenome 总部位于。

Brisbane, California

布里斯班，加利福尼亚州

. Find out more at

. 欲了解更多信息，请访问

www.freenome.com

and visit us on

并访问我们

领英

。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the PREEMPT CRC, the use of information from that study, and Freenome's plans and expectations regarding its FDA submission, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements.

本新闻稿包含联邦证券法意义上的前瞻性声明，包括关于PREEMPT CRC、该研究信息的使用以及Freenome对其FDA提交的计划和期望的声明，这些声明涉及可能导致实际结果与这些前瞻性声明中表达的预期结果和期望存在重大差异的风险和不确定性。

These statements are based on current expectations, forecasts, and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. The forward-looking statements in this press release are based on information available to Freenome as of the date hereof, and Freenome disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law.

这些声明基于当前的预期、预测和假设，由于许多因素的影响，实际结果可能与这些声明存在重大差异。本新闻稿中的前瞻性声明基于截至今日Freenome可获得的信息，且Freenome拒绝承担更新任何前瞻性声明的义务，以反映其预期或基于该声明的事件、条件或情况的任何变化，除非法律要求。

These forward-looking statements should not be relied upon as representing Freenome's views as of any date subsequent to the date of this press release..

这些前瞻性陈述不应被视为代表Freenome在本新闻稿发布日期之后的任何日期的观点。

References

参考文献

1. Shaukat A, Burke CA, Chan AT, et al. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer.

1. Shaukat A, Burke CA, Chan AT, 等。基于循环肿瘤DNA血液检测筛查结直肠癌的临床验证。

JAMA

美国医学会杂志

. Published online

在线发布

June 2, 2025

2025年6月2日

。