NEW YORK – Cancer early detection firm Grail said on Thursday that it has submitted its multi-cancer early detection test Galleri to the US Food and Drug Administration for premarket approval.

纽约——癌症早期检测公司Grail周四表示，已向美国食品和药物管理局提交了其多癌早期检测测试Galleri以申请上市前批准。

The submission is focused on the test performance and safety results from 25,490 adults in the US-based

提交的内容集中在美国的25,490名成年人的测试性能和安全结果上。

Pathfinder 2 study

Pathfinder 2 学习

with one year of follow up and from the first year of the

随访一年，并从第一年开始

NHS-Galleri trial

NHS-Galleri试验

in the UK. In addition, the submission is supported by a bridging analysis to compare the performance of the version of Galleri used in Pathfinder 2 and NHS-Galleri to the updated version submitted for premarket approval, the company noted in a statement.

在英国。此外，该公司在一份声明中指出，此次提交还得到了一项桥接分析的支持，该分析比较了Pathfinder 2和NHS-Galleri中使用的Galleri版本与提交上市前审批的更新版本的性能。

The FDA designated Galleri as a breakthrough device in 2018.

FDA于2018年将Galleri指定为突破性设备。

Pathfinder 2 is a prospective multi-center interventional study to evaluate the safety and performance of Galleri in 35,000 people aged 50 years and older who are eligible for guideline-recommended cancer screening in the US. The study looks at the number and type of diagnostic evaluations in participants who receive a positive Galleri test result and at the performance of the test across various metrics including positive and negative predictive value, sensitivity, specificity, and cancer signal origin prediction accuracy..

Pathfinder 2 是一项前瞻性多中心干预研究，旨在评估 Galleri 在美国 35,000 名 50 岁及以上符合指南推荐的癌症筛查条件的人群中的安全性和性能。该研究关注接受 Galleri 检测结果呈阳性的参与者所进行的诊断评估的数量和类型，并评估该检测在多种指标上的表现，包括阳性与阴性预测值、灵敏度、特异性以及癌症信号来源预测的准确性。

NHS-Galleri is a prospective randomized controlled trial to assess Galleri's clinical utility and performance when added to standard care. It includes more than 140,000 asymptomatic people aged 50 to 77 who provided three blood samples over two years. The primary aim is to show a reduction in late-stage cancers in people who received the test.

NHS-Galleri 是一项前瞻性随机对照试验，旨在评估将 Galleri 添加到标准护理时的临床效用和性能。该试验包括超过 140,000 名年龄在 50 至 77 岁之间的无症状参与者，他们在两年内提供了三个血液样本。主要目标是证明接受测试的人群晚期癌症发病率有所降低。

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'Adding Galleri to standard-of-care single-cancer screening tests has the potential to dramatically improve the performance of the nation's current screening program and expand opportunities for earlier treatment and improved outcomes,' Grail President Josh Ofman said in a statement. 'Galleri has been rigorously studied in case-controlled and interventional studies.

“将Galleri添加到标准的单癌筛查测试中，有可能极大地提升当前国家筛查项目的表现，并增加早期治疗和改善预后的机会，”Grail总裁Josh Ofman在一份声明中表示。“Galleri已经在病例对照和干预性研究中经过了严格的测试。”

This FDA submission marks a critical step toward making Galleri available to more people and advancing early detection to provide a significant public health benefit.'.

此次FDA提交标志着使Galleri能够面向更多人使用，并推进早期检测以提供显著公共卫生效益的关键一步。

In a note to investors, Canaccord Genuity analyst Kyle Mikson wrote that the submission 'marks a critical step toward making Galleri available to a broader range of individuals and should help advance early detection.' He added that Galleri could be approved by mid-2027, which would be ahead of previous expectations.

在给投资者的报告中，Canaccord Genuity 分析师凯尔·米克森写道，此次提交“标志着让 Galleri 惠及更广泛人群的关键一步，并将有助于推动早期检测。”他补充称，Galleri 有望在 2027 年年中获批，这比之前的预期要早。

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