Cancer Detection and Positive Predictive Value Substantially Higher Than the Previously Published PATHFINDER Study

癌症检测和阳性预测值显著高于之前发表的PATHFINDER研究

MENLO PARK, Calif.

门洛帕克，加利福尼亚州

,

，

June 18, 2025

2025年6月18日

/PRNewswire/ -- GRAIL, Inc. (Nasdaq:

/PRNewswire/ -- GRAIL, Inc. (纳斯达克:

GRAL

通用机器人抽象层

), a healthcare company whose mission is to detect cancer early when it can be cured, today announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL's registrational PATHFINDER 2 study. PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri.

)，一家致力于在癌症可以治愈的时候早期检测到癌症的医疗公司，今天宣布了从GRAIL的注册PATHFINDER 2研究的首批25,578名参与者预先指定分析中获得的积极顶级表现和安全结果。PATHFINDER 2研究于2021年启动，旨在评估Galleri的安全性和性能。

®

®

multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer.

在35,878名50岁以上无癌症临床怀疑的成年人中，将多癌症早期检测（MCED）测试添加到标准的单癌筛查中。

In the previously published

在之前发表的

PATHFINDER

路径寻找者

study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening. In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER.

研究显示，将Galleri检测加入标准癌症筛查方法，可使通过筛查发现的癌症总数增加一倍以上。在PATHFINDER 2试验中，将Galleri加入标准筛查显示出比PATHFINDER更显著的额外癌症检测效果。

In PATHFINDER, Galleri demonstrated a positive predictive value (PPV), or likelihood that a positive Galleri test was confirmed to be cancer, of 43%; specificity of 99.5%; and 88% cancer signal origin (CSO) accuracy. Data from evaluable PATHFINDER 2 participants with 12 months of follow-up showed a substantially higher PPV than that observed in the PATHFINDER study.

在PATHFINDER研究中，Galleri展示了43%的阳性预测值（PPV），即Galleri检测结果为阳性时确认为癌症的可能性；特异性为99.5%；癌症信号来源（CSO）准确性为88%。来自可评估的PATHFINDER 2参与者的数据显示，在12个月的随访后，其PPV显著高于PATHFINDER研究中观察到的结果。

CSO accuracy and specificity were consistent with that observed in the PATHFINDER study..

CSO的准确性和特异性与PATHFINDER研究中观察到的一致。

There were no serious safety concerns reported in PATHFINDER 2.

PATHFINDER 2中没有报告严重的安全隐患。

'We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial's prevalent screening round,' said

“我们很高兴看到Galleri MCED测试作为癌症筛查工具在PATHFINDER 2研究和NHS-Galleri试验的普遍筛查阶段中，针对50岁以上无症状成年人的广泛目标人群中表现出非常令人鼓舞的效果，”

Josh Ofman

约什·奥夫曼

, MD, MSHS, President at GRAIL. 'We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward.

医学博士、公共卫生硕士、GRAIL公司总裁：“我们要向这两项关键研究中的所有参与者和研究人员致以诚挚的感谢，他们正在共同努力，帮助实现这项突破性技术在人群规模上进行多癌症早期检测的潜力，并推动该领域的发展。

We look forward to sharing the detailed PATHFINDER 2 data at a medical congress later this year.'.

我们期待在今年晚些时候的医学大会上分享详细的PATHFINDER 2数据。

PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval.

PATHFINDER 2 研究结果将与 NHS-Galleri 试验的普遍筛查轮次数据一起，作为 Galleri 上市前审批申请 (PMA) 的一部分提交给美国食品药品监督管理局 (FDA)。此外，GRAIL 将向 FDA 提交桥接分析，以比较 PATHFINDER 2 研究和 NHS-Galleri 试验中使用的 Galleri 版本与 GRAIL 计划提交给 FDA 以申请上市前批准的更新版本的性能。

The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026..

Galleri的PMA目前正在根据FDA的突破性设备指定进行模块化提交。GRAIL预计将在2026年上半年完成PMA模块化提交。

Detailed results from the PATHFINDER 2 study will be submitted for presentation at a leading international oncology meeting before the end of the year.

PATHFINDER 2 研究的详细结果将在年底前提交，以便在领先的国际肿瘤学会议上展示。

About the PATHFINDER 2 Study (

关于PATHFINDER 2研究 (

NCT05155605

NCT05155605

)

)

PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in

PATHFINDER 2 是一项前瞻性、多中心、干预性研究，评估 Galleri 在约 35,000 名 50 岁及以上符合指南推荐的癌症筛查条件的个体中的安全性和性能。

the United States

美国

. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy.

本研究的主要目标是：1）根据接受癌症信号检测结果的参与者所进行的诊断评估的数量和类型，评估Galleri MCED测试的安全性和有效性；2）评估Galleri MCED测试在不同指标上的性能，包括阳性预测值（PPV）、阴性预测值（NPV）、灵敏度、特异性和CSO预测准确性。

Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes (PRO) over several time points, including an assessment of participants' anxiety and satisfaction with the MCED test..

接收到癌症信号检测结果的参与者将根据预测的CSO进行额外的诊断测试，以确定是否存在癌症。次要目标包括在使用MCED测试后，对指南推荐的癌症筛查程序的利用情况，以及参与者在多个时间点报告的结果（PRO），其中包括对参与者焦虑程度及对MCED测试满意度的评估。

About GRAIL

关于GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages.

GRAIL是一家医疗保健公司，其使命是早期发现癌症，以便能够治愈。GRAIL致力于通过利用下一代测序技术、大规模人群临床研究以及最先进的机器学习、软件和自动化技术，来检测和识别多种致命癌症的早期阶段，从而减轻全球癌症负担。

GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in .

GRAIL的靶向甲基化平台可以支持筛查和精准肿瘤学的连续护理，包括对有症状患者的多癌早期检测、风险分层、微小残留病灶检测、生物标志物亚型分析、治疗和复发监测。GRAIL总部位于 。

Menlo Park, CA

门洛帕克，加利福尼亚州

with locations in

位于

Washington, D.C.

华盛顿特区

,

，

North Carolina

北卡罗来纳州

, and the

，以及

United Kingdom

英国

.

。

For more information, visit

欲了解更多信息，请访问

grail.com

grail.com

.

。

About Galleri

关于Galleri

®

®

The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique 'fingerprint' of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.

Galleri多癌症早期检测测试是一种用于癌症筛查的前瞻性工具。通过简单的抽血，Galleri测试可以识别癌细胞脱落的DNA，这些DNA可以作为癌症的独特“指纹”，帮助筛查目前尚无推荐筛查方法的一些最致命的癌症，如胰腺癌、食道癌、卵巢癌、肝癌等。

The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening.

Galleri测试可以在一个人出现症状之前进行癌症筛查，这时癌症可能更容易治疗且有可能治愈。Galleri测试可以指示癌症的起源，为医疗保健提供者提供进一步探索的方向。Galleri测试需要由有执照的医疗保健提供者开具处方，并且应该作为推荐的癌症筛查（如乳腺X光摄影、结肠镜检查、前列腺特异性抗原（PSA）测试或宫颈癌筛查）的补充使用。

The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older..

Galleri测试推荐给癌症风险较高的成年人，例如50岁或以上的人群。

For more information, visit

欲了解更多信息，请访问

galleri.com

画廊.com

.

。

Important Galleri Safety Information

重要的Galleri安全信息

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located.

Galleri测试建议用于癌症风险较高的成年人，例如50岁或以上的人群。该测试并不能检测所有癌症，应作为医疗保健提供者推荐的常规癌症筛查测试的补充。Galleri测试旨在检测癌症信号并预测癌症信号在体内的位置。

Use of the test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment..

不建议孕妇、21岁或以下人士以及正在接受癌症治疗的个体使用该测试。

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal Detected does not rule out cancer. A test result of Cancer Signal Detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer..

结果应由医疗保健提供者结合病史、临床体征和症状进行解读。未检测到癌症信号的检测结果并不能排除癌症。检测到癌症信号的检测结果需要通过医学上已确立的程序（例如影像学检查）进行确认性诊断评估以确认癌症。

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False positive (a cancer signal detected when cancer is not present) and false negative (a cancer signal not detected when cancer is present) test results do occur.

如果通过进一步检测未确认癌症，这可能意味着没有癌症，或者检测不足以发现癌症，包括由于癌症位于身体的不同部位。假阳性（在没有癌症时检测到癌症信号）和假阴性（在有癌症时未检测到癌症信号）的检测结果确实会发生。

.

。

Rx only.

仅处方药。

Laboratory/Test Information

实验室/测试信息

The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed — and its performance characteristics were determined — by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration.

GRAIL临床实验室根据1988年的《临床实验室改进修正案》（CLIA）获得认证，并由美国病理学家学会认可。Galleri测试由GRAIL开发，并且其性能特征已由GRAIL确定。Galleri测试尚未获得食品和药物管理局的批准或认可。

The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes..

GRAIL临床实验室受CLIA监管，进行高复杂性检测。Galleri测试旨在用于临床目的。

Forward Looking Statements

前瞻性声明

This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as 'aim,' 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'should,' 'would,' or 'will,' the negative of these terms, and other comparable terminology.

本新闻稿包含前瞻性陈述。在某些情况下，您可以通过诸如“目标”、“预期”、“相信”、“继续”、“可能”、“估计”、“期望”、“打算”、“或许”、“可能”、“计划”、“潜力”、“预测”、“应该”、“将”、“会”等前瞻性词语，以及这些词语的否定形式和其他类似术语来识别这些陈述。

These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, include the benefits and use of the Galleri test, the potential of the Galleri MCED test, upcoming events and presentations, the timeline for submission of PATHFINDER 2 study results and a bridging analyses to the FDA, and the timeline for completion of the PMA modular submission..

这些前瞻性陈述涉及与我们相关的风险、不确定性和假设，包括Galleri测试的益处和用途、Galleri MCED测试的潜力、即将举行的活动和报告、向FDA提交PATHFINDER 2研究结果及桥接分析的时间表，以及PMA模块化提交的完成时间表。

These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled 'Risk Factors' in our Annual Report on Form 10-Q for the period ended .

这些声明仅为基于我们当前对未来事件和趋势的预期和预测。实际结果、活动水平、业绩或成就可能与前瞻性声明中明示或暗示的内容存在重大差异，导致这种差异的重要因素包括众多相关风险，这些因素和风险已在我们截至某日的10-Q表年度报告中“风险因素”部分进行了讨论。

March 31, 2025

2025年3月31日

and our Form 10-K for the period ended

截至本期末的10-K表格

December 31, 2024

2024年12月31日

(the 'Form 10-K'). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make..

（“表格10-K”）。此外，我们处在一个动态且快速变化的环境中。新的风险不时出现。我们的管理层无法预测所有风险，也无法评估所有因素对我们业务的影响，或任何因素或因素组合可能导致实际结果、活动水平、表现或成就与我们可能做出的前瞻性陈述中包含的内容产生重大不利差异的程度。

Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements.

前瞻性声明涉及未来，因此受到固有的不确定性、风险和难以预测的环境变化的影响，其中许多是我们无法控制的。尽管我们认为前瞻性声明中表达或暗示的预期和预测是合理的，但我们无法保证未来的成果、活动水平、表现或成就。

Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events..

我们的实际结果和财务状况可能与前瞻性陈述中所示的内容有重大差异。除非法律要求，我们不承担在本新闻稿发布日期之后更新任何前瞻性陈述的义务，以使我们之前的陈述符合实际结果或修订后的预期，或反映新信息或未预见事件的发生。

SOURCE GRAIL, Inc.

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