阿尔茨海默病协会关于首个用于诊断阿尔茨海默病的血液检测方法获FDA批准使用的声明-动脉网

Alzheimer's Association Statement on First Blood Test Used in Diagnosing Alzheimer's Disease Cleared for Use by FDA

CISION 等信源发布 2025-05-17 05:41

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CHICAGO

芝加哥

，

May 16, 2025

2025年5月16日

/PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has

/PRNewswire/ -- 美国食品和药物管理局 (FDA) 已

cleared

已清除

the first blood test to aid in diagnosis of Alzheimer's disease. The test detects amyloid plaques, a hallmark of Alzheimer's disease, through a blood draw, making it less invasive than other more commonly used diagnostic tools.

首个用于辅助诊断阿尔茨海默病的血液检测。该测试通过抽血检测β淀粉样蛋白斑块（阿尔茨海默病的标志性特征），相比其他更常用的诊断工具，其侵入性更低。

'Today marks another important step in Alzheimer's disease diagnosis,' said

“今天标志着阿尔茨海默病诊断的又一个重要步骤，”

Maria C. Carrillo

玛丽亚·C·卡里略

, Ph.D.

，博士

, Alzheimer's Association chief science officer and medical affairs lead. 'For too long Americans have struggled to get a simple and accurate diagnosis; with today's action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier.'

阿尔茨海默病协会首席科学官兼医学事务主管表示：“长期以来，美国人一直在努力获取简单而准确的诊断；随着FDA今天的行动，我们希望更多人能够更早地获得准确的诊断。”

While there is no single, stand-alone test to diagnose Alzheimer's disease today — including this newly approved test — blood testing can be an important piece of the diagnostic process. Currently, physicians primarily use other, more well-established diagnostic tools combined with medical history, neurological exams, cognitive and functional assessments, brain imaging, spinal fluid analysis — and, increasingly, blood tests — to make an accurate diagnosis and to understand which patients are eligible for approved treatments..

虽然目前还没有单一的、独立的测试来诊断阿尔茨海默病——包括这个新批准的测试——但血液检测可以成为诊断过程中的重要一环。目前，医生主要结合病史、神经系统检查、认知和功能评估、脑成像、脊髓液分析——以及越来越多的血液测试——使用其他更成熟的诊断工具来进行准确诊断，并确定哪些患者适合已批准的治疗方案。

According to the FDA, 'the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer's disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.'

根据美国食品药品监督管理局（FDA）的说法，“Lumipulse G pTau217/ß-淀粉样蛋白1-42血浆比率用于早期检测与阿尔茨海默病相关的淀粉样蛋白斑块，适用于55岁及以上表现出该疾病症状的成年患者。”

There are a variety of laboratory-developed tests on the market that can be used to detect blood-based biomarkers associated with Alzheimer's. This is the first that has been cleared by the FDA for use. For many years, blood tests have been used in clinical trials. Increasingly, they are being used by specialists in clinical settings, often as a first pass detection tool followed by additional testing..

市场上有多种可用于检测与阿尔茨海默病相关的血液生物标志物的实验室开发测试。这是首个获FDA批准使用的测试。多年来，血液测试一直被用于临床试验。如今，在临床环境中，这些测试越来越多地被专科医生使用，通常作为初步筛查工具，随后再进行更多测试。

'Blood-based biomarkers are reshaping how we identify and understand Alzheimer's disease,' continued Carrillo. 'At the same time, there are important questions for health care professionals to consider; in particular, who should be tested and when.'

“基于血液的生物标志物正在重塑我们识别和理解阿尔茨海默病的方式，”卡里略继续说道。“同时，医疗保健专业人员需要考虑一些重要问题；特别是，谁应该接受测试以及何时进行测试。”

The Alzheimer's Association is leading the development of clinical practice guidelines for the use of blood biomarker tests in specialty care settings, which will be debuted this summer at the

阿尔茨海默病协会正在牵头制定在专科护理环境中使用血液生物标志物测试的临床实践指南，该指南将于今年夏天首次发布。

Alzheimer's Association International Conference

阿尔茨海默病协会国际会议

(AAIC),

（AAIC），

July 27-31

7月27日至31日

在

Toronto

多伦多

and online. The first iteration of the clinical practice guidelines will provide evidence-based recommendations for specialists to help guide them through the decision-making process around who should be tested and when. In the meantime, the Association urges providers to refer to the 2022

线上。临床实践指南的第一次迭代将为专科医生提供基于证据的建议，以帮助指导他们进行关于谁应该接受测试以及何时进行测试的决策过程。与此同时，协会敦促供应商参考2022年版。

appropriate use recommendations

合理使用建议

for blood tests in clinical practice and trial settings.

用于临床实践和试验环境中的血液检测。

The

2025 Alzheimer's Disease Facts and Figures special report

2025年阿尔茨海默病事实与数据特别报告

found that nearly 4 in 5 Americans would want to know if they had Alzheimer's disease before it impacted their lives. Specifically, 91% of Americans say they would want to take a simple test — such as a blood biomarker test — if it were available. Access to early treatment and care is the main reason cited for wanting a simple test..

发现近五分之四的美国人希望在阿尔茨海默病影响他们的生活之前就知道自己是否患病。具体来说，91%的美国人表示，如果有简单的检测方法，比如血液生物标志物检测，他们会愿意进行检测。获取早期治疗和护理是人们希望进行简单检测的主要原因。

'This interest in early diagnosis and treatment highlights how important it is that we keep advancing toward diagnostic testing that is simple to administer and widely available,' Carrillo said.

“这种对早期诊断和治疗的兴趣突显了我们必须不断推进简单易行且广泛可用的诊断测试的重要性，”卡里略说。

This is the latest step toward better diagnosis and eventual treatment of Alzheimer's disease made possible by historic investment in Alzheimer's and dementia research by the National Institutes of Health (NIH), the Alzheimer's Association and other private entities. As a result of this increased investment, scientists have been able to work at a more rapid pace to advance basic disease knowledge, identify ways to reduce risk, uncover new biomarkers for early diagnosis and drug targeting, and develop disease-modifying treatments..

这是美国国立卫生研究院 (NIH)、阿尔茨海默病协会和其他私人机构对阿尔茨海默病和痴呆研究进行历史性投资后，在更好地诊断和最终治疗阿尔茨海默病方面取得的最新进展。由于这项投资的增加，科学家们能够以更快的速度推进基础疾病知识、识别降低风险的方法、发现用于早期诊断和药物靶向的新生物标志物，并开发改变疾病的治疗方法。

About the Alzheimer's Association

关于阿尔茨海默病协会

The Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support.

阿尔茨海默病协会是一个全球性的自愿健康组织，致力于阿尔茨海默病的护理、支持和研究。我们的使命是通过加速全球研究、推动风险降低和早期检测，以及最大化护理和支持的质量，引领终结阿尔茨海默病和所有其他痴呆症的道路。

Our vision is a world without Alzheimer's and all other dementia®. Visit .

我们的愿景是一个没有阿尔茨海默病和所有其他痴呆症®的世界。访问。

alz.org

or call 800.272.3900.

或拨打800.272.3900。

SOURCE Alzheimer's Association

来源：阿尔茨海默病协会

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