MENLO PARK, Calif.--(BUSINESS WIRE)--GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced that it will initiate Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare study) following the U.S. Food and Drug Administration’s (FDA) approval of GRAIL’s Investigational Device Exemption (IDE) application and the Centers for Medicare and Medicaid Services’ (CMS) approval for Medicare coverage of the study.

加州门洛帕克（BUSINESS WIRE）-GRAIL，LLC，一家医疗保健公司，其使命是在癌症治愈后尽早发现癌症，今天宣布，在美国食品和药物管理局（FDA）批准GRAIL的研究设备豁免（IDE）申请以及医疗保险和医疗补助中心之后，它将启动现实世界的证据来推进多癌症早期检测健康公平（REACH/Galleri-Medicare研究）。服务（CMS）批准医疗保险覆盖范围的研究。

With age being the most significant risk factor for cancer, Medicare beneficiaries face the highest unmet need for early cancer detection..

随着年龄成为癌症最重要的危险因素，医疗保险受益人面临着对早期癌症检测的最高未满足需求。。

The Galleri-Medicare study is a first-of-its-kind real-world study designed to further evaluate the clinical impact of the Galleri® multi-cancer early detection (MCED) test among Medicare beneficiaries, including racial and ethnic minorities, and seniors from historically under-served communities. The Galleri-Medicare study seeks to compare up to 50,000 Medicare beneficiaries who have received usual care plus an annual Galleri test with a matched comparator arm of beneficiaries who receive usual care alone.

Galleri-Medicare研究是首次进行的现实世界研究，旨在进一步评估Galleri®多癌症早期检测（MCED）测试对医疗保险受益人（包括种族和少数民族）以及历史上的老年人的临床影响服务社区。Galleri-Medicare研究旨在比较多达50000名接受常规护理的Medicare受益人和年度Galleri测试，以及单独接受常规护理的受益人的匹配比较组。

Medicare will cover the costs of Galleri and related and routine items and services for study participants..

Medicare将支付Galleri的费用以及研究参与者的相关和日常物品和服务。。

“Although recommended cancer screening tests save lives, they are only available in the U.S. for three types of cancers for women, and two types for men, with an additional screening for those with a heavy smoking history. Multi-cancer early detection holds the promise to detect more cancers earlier, improve cancer outcomes, and reduce overall cancer costs, but only if accessible to all seniors,” said Bob Ragusa, chief executive officer at GRAIL.

“虽然推荐的癌症筛查测试可以挽救生命，但它们仅在美国适用于女性的三种癌症和男性的两种癌症，并对吸烟史较重的患者进行额外筛查。多癌症早期发现有望更早发现更多癌症，改善癌症预后并降低总体癌症成本，但前提是所有老年人都可以使用，“GRAIL首席执行官Bob Ragusa说。

“The Galleri-Medicare study demonstrates our commitment to provide broad, equitable access to early cancer detection that is representative of the U.S. population, including groups that are often under-represented in clinical research. GRAIL designed the Galleri-Medicare study to meet the aspirations of the Cancer Moonshot’s goal of advancing early detection, add to our robust ongoing real-world evidence generation, and continue to demonstrate Galleri’s clinical benefit for early detection.”.

“Galleri-Medicare研究表明，我们承诺为代表美国人口的早期癌症检测提供广泛，公平的机会，包括临床研究中代表性不足的群体.GRAIL设计了Galleri-Medicare研究，以满足癌症Moonshot推进早期发现的目标，增加了我们强大的持续真实world证据的产生，并继续证明Galleri对早期发现的临床益处。”。

More than 600,000 people died from cancer last year in the United States with over 400,000 of those deaths among people age 65 and older. More than half of all cancer diagnoses are among Medicare beneficiaries who are at the highest risk for cancer due to age. This is largely because the majority of cancers that result in death are found too late when outcomes are often poor.

去年在美国，超过60万人死于癌症，其中65岁及以上的人死亡人数超过40万。所有癌症诊断中有一半以上属于医疗保险受益人，他们因年龄增长而患癌症的风险最高。这主要是因为大多数导致死亡的癌症在结果往往很差的时候发现得太晚了。

In fact, about seven in 10 cancer deaths are from cancers that lack recommended early detection screening..

事实上，大约十分之七的癌症死亡是由于缺乏推荐的早期检测筛查的癌症。。

“New approaches to screening for cancers hold the potential to transform oncology research and care, and most importantly, improve patient outcomes,” said Jeff Allen, President & CEO of Friends of Cancer Research, “This new real-world evidence program will augment the ongoing randomized clinical trial and generate the necessary clinical impact data to optimize the use of multi-cancer early detection testing in the broad population.”.

癌症研究之友总裁兼首席执行官杰夫·艾伦（Jeff Allen）说：“筛查癌症的新方法有可能改变肿瘤学研究和护理，最重要的是改善患者预后，“这个新的现实世界证据计划将扩大正在进行的随机临床试验，并产生必要的临床影响数据，以优化在广泛人群中使用多癌症早期检测测试。”。

Racial and ethnic minorities continue to bear a higher cancer burden, and late-stage diagnosis of unscreened cancers remains disproportionately higher among Black and Brown communities, according to the National Minority Quality Forum. The Galleri-Medicare study will seek to include Medicare participants from under-represented populations across race, ethnicity, socioeconomic status and underserved communities..

根据少数民族质量论坛的统计，种族和少数民族继续承担更高的癌症负担，黑人和棕色社区对未经筛查的癌症的晚期诊断仍然高得多。Galleri-Medicare研究将寻求包括来自种族，民族，社会经济地位和服务不足社区的代表性不足人群的Medicare参与者。。

Garfield A.D. Clunie, MD, the 123rd president of the National Medical Association (NMA), the nation's oldest and largest association of African American/Black physicians said, 'The National Medical Association (NMA) is the nation's leading voice for advocacy for health equity and the elimination of health disparities.

国家医学协会（NMA）第123届主席Garfield A.D.Clunie博士说，该国最古老和最大的非洲裔美国人/黑人医师协会表示，“全国医学协会（NMA）是全国倡导健康的领先声音公平和消除健康差距。

NMA uniquely understands that equitable access to early cancer detection has the potential to achieve better outcomes in diverse populations with a potential to combat barriers to care such as access and reduction of stigma that present challenges. The NMA asserts that earlier diagnosis can only be achieved if all patients have broad access to MCED tests.

NMA独特地理解，公平获得早期癌症检测有可能在不同人群中取得更好的结果，并有可能对抗护理障碍，例如获取和减少带来挑战的耻辱感。NMA声称，只有所有患者都可以广泛接受MCED检测，才能实现早期诊断。

This innovative study will help provide access to game-changing cancer detection technology for our nation's seniors and we applaud the added outreach efforts to engage those who are minority and underrepresented populations in underserved areas to further add to the growing body of representative real-world evidence.”.

这项创新性研究将有助于为我们国家的老年人提供改变游戏规则的癌症检测技术，我们赞扬额外的外联努力，让服务不足地区的少数民族和代表性不足的人群参与进来，以进一步增加越来越多的具有代表性的现实世界证据“。

In addition to the robust clinical evidence collection from GRAIL’s IDE-approved studies - such as the NHS-Galleri trial and the US PATHFINDER 2 trial - the Galleri-Medicare study will generate large-scale real-world evidence of Galleri performance and outcomes in the diverse Medicare population. The clinical impact measures of interest in the study include reduction in diagnosed stage IV cancers, safety, and healthcare resource utilization associated with diagnostic workup for suspected cancer within the interventional arm compared to usual care.

除了GRAIL IDE批准的研究（如NHS Galleri试验和美国PATHFINDER 2试验）收集的强有力的临床证据外，Galleri-Medicare研究还将产生大规模现实世界的Galleri表现和多样化医疗保险结果的证据人口。研究中感兴趣的临床影响措施包括与常规护理相比，减少诊断的IV期癌症，安全性和与介入组内疑似癌症的诊断检查相关的医疗资源利用。

While study timelines are still under development, it is anticipated that interim study data will be available for CMS consideration in the event of FDA approval of a premarket approval application (PMA) for Galleri..

虽然研究时间表仍在制定中，但预计如果FDA批准Galleri的上市前批准申请（PMA），中期研究数据将可供CMS考虑。。

“At the heart of our work at GRAIL is the unique ability to generate large-scale evidence of Galleri’s clinical impact that supports broad, equitable access from multiple studies and hundreds of thousands of individuals, including diverse populations, and population-scale partnerships with dozens of major health care institutions in the U.S.

“我们在GRAIL工作的核心是能够产生大规模的Galleri临床影响证据的独特能力，支持来自多项研究和数十万人（包括不同人群）的广泛，公平的获取，以及与美国数十家主要医疗机构的人口规模合作关系。

and in England’s National Health Service. We expect that the data collected from the Galleri-Medicare study will add to the growing body of evidence that MCED has the potential to change the future of cancer detection as we know it,” said Josh Ofman, MD, MSHS, President at GRAIL. “To bend the cancer mortality curve downwards, we have to shift from only screening for a few individual cancers to also screening individuals for many cancers lacking screening, which we believe will lead to better outcomes and lower diagnosis and treatment costs.”.

和英国国家卫生局。GRAIL总裁MSHS医学博士Josh Ofman说，我们预计从Galleri-Medicare研究中收集的数据将增加越来越多的证据表明MCED有可能改变癌症检测的未来。“为了使癌症死亡率曲线向下弯曲，我们必须从仅筛查少数个体癌症转向筛查许多缺乏筛查的癌症，我们相信这将导致更好的结果和更低的诊断和治疗成本。”。

This growing body of evidence includes the final results of GRAIL’s prospective PATHFINDER study that were recently published in The Lancet, demonstrating that adding MCED screening to standard of care screening more than doubled the number of cancers detected compared with standard of care screening alone.

越来越多的证据包括最近在“柳叶刀”杂志上发表的GRAIL前瞻性寻路者研究的最终结果，表明将MCED筛查纳入标准治疗筛查的癌症检出数量比单独标准治疗筛查增加了一倍以上。

Most of the cancers found had no recommended screening options, and nearly half detected were in their early stages. At ASCO 2023, GRAIL presented new data demonstrating that the real-world performance of MCED is generally consistent to that seen in PATHFINDER. Additionally, in partnership with England’s National Health Service, NHS-Galleri is an ongoing randomized controlled trial of more than 140,000 participants with the primary objective of reducing late-stage cancer diagnoses, in line with the UK’s overarching goal of finding cancer early for its population.

发现的大多数癌症没有推荐的筛查方案，近一半的癌症处于早期阶段。在ASCO 2023，GRAIL提供了新的数据，证明MCED的实际表现与PATHFINDER中的表现基本一致。此外，与英格兰国家卫生服务局合作，NHS Galleri正在进行一项超过14万名参与者的随机对照试验，其主要目标是减少晚期癌症诊断，这符合英国为其人群尽早发现癌症的首要目标。

In addition, to date, more than 100,000 commercial Galleri tests have been processed..

此外，迄今为止，已经处理了超过100000个商业厨房测试。。

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，其使命是在癌症治愈的时候尽早发现癌症。GRAIL专注于通过利用新一代测序，人口规模临床研究以及最先进的机器学习，软件和自动化的功能来减轻全球癌症负担，以检测和识别多种致命的癌症类型。早期阶段。

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 Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom.

GRAIL的靶向甲基化平台可以支持连续的筛查和精确肿瘤学护理，包括有症状患者的多癌症早期检测，风险分层，微小残留病检测，生物标志物亚型分型，治疗和复发监测。GRAIL总部设在加利福尼亚州门洛帕克，位于华盛顿特区，北卡罗来纳州和英国。

GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission..

GRAIL，LLC是Illumina，Inc。（纳斯达克股票代码：ILMN）的子公司，目前根据欧盟委员会临时措施命令的条款与Illumina Inc.分开持有。。

For more information, visit grail.com.

欲了解更多信息，请访问grail.com。

Important Information About the REACH Study

关于REACH研究的重要信息

The REACH Study is sponsored by GRAIL and will enroll approximately 50,000 participants across several health systems. The REACH Study is being conducted under FDA’s approval of an IDE application. More information about the REACH Study will be available on clinicaltrials.gov.

REACH研究由GRAIL赞助，将在多个卫生系统招收约50000名参与者。REACH研究正在FDA批准IDE申请下进行。有关REACH研究的更多信息，请访问clinicaltrials.gov。

Galleri is a blood-based multi-cancer early detection (MCED) test. In prior clinical studies, Galleri has shown the ability to detect a signal shared by more than 50 types of cancer through a routine blood draw. If a cancer signal is detected, the Galleri test predicts the location or origin of the cancer..

Galleri是一种基于血液的多癌症早期检测（MCED）测试。在先前的临床研究中，Galleri已显示出通过常规抽血检测50多种癌症共有的信号的能力。如果检测到癌症信号，Galleri测试可预测癌症的位置或起源。。

In the REACH Study, the Galleri test is an investigational test with associated risks and benefits that are described in the study materials. Risks of the test include, but are not limited to, false-positive results (a cancer signal detected when cancer is not present), false-negative results (no cancer signal detected when cancer is present), and incorrect prediction of the location or origin of a cancer signal.

在REACH研究中，Galleri测试是一项研究测试，具有研究材料中描述的相关风险和益处。测试的风险包括但不限于假阳性结果（当癌症不存在时检测到癌症信号），假阴性结果（当癌症存在时未检测到癌症信号）以及对位置的错误预测或癌症信号的起源。

The Galleri test should not replace any guideline-recommended screenings or other standard of care diagnostic or treatment options..

Galleri测试不应取代任何指南推荐的筛查或其他标准护理诊断或治疗选择。。

Laboratory/Test Information

实验室/测试信息

GRAIL’s 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing.

GRAIL的临床实验室已获得1988年临床实验室改进修正案（CLIA）的认证，并获得了美国病理学家学院的认可。开发了Galleri测试，其性能特征由GRAIL确定。GRAIL的临床实验室受CLIA监管，以执行高复杂度测试。

The Galleri test is intended for clinical purposes..

Galleri测试旨在用于临床目的。。