Beckman Coulter获得FDA阿尔茨海默病血液检测突破性设备称号-动脉网

Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer's Disease Blood Test

CISION 等信源发布 2025-01-28 21:30

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BREA, Calif.

布雷亚，加利福尼亚州。

Jan. 28, 2025

/PRNewswire/ -- Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter's Access p‑Tau217/β-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer's disease..

/PRNewswire/--临床诊断领域的全球领导者贝克曼·库尔特诊断公司今天宣布，美国食品和药物管理局（FDA）已授予贝克曼·库尔特公司的Access p-Tau217/β-淀粉样蛋白1-42血浆比例突破性设备名称。该血液测试旨在帮助医疗保健提供者识别与阿尔茨海默氏病相关的淀粉样蛋白病理患者。。

继续阅读

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter’s Access p‑Tau217/β-Amyloid 1-42 plasma ratio Test.

美国食品和药物管理局（FDA）已授予贝克曼·库尔特（Beckman Coulter）的Access p-Tau217/β-淀粉样蛋白1-42血浆比率测试突破性的设备名称。

'We are honored to receive Breakthrough Device Designation from the U.S. FDA for our p‑Tau217/β-Amyloid 1-42 assay, a significant step forward in addressing the urgent need for earlier and more accurate detection of Amyloid pathology, a hallmark of Alzheimer's disease,' said Kathleen Orland, Senior Vice President, General Manager, Clinical Chemistry and Immunoassay for Beckman Coulter Diagnostics.

贝克曼库尔特诊断公司（Beckman Coulter Diagnostics）临床化学和免疫分析高级副总裁兼总经理凯萨琳·奥尔兰（Kathleen Orland）说：“我们很荣幸获得美国FDA对p-Tau217/β-淀粉样蛋白1-42检测的突破性设备指定，这是在解决早期和更准确检测淀粉样蛋白病理学（阿尔茨海默病的标志）的迫切需求方面迈出的重要一步。”。

'This designation reflects the potential of our test to transform how Alzheimer's disease is diagnosed and managed, ultimately leading to improved outcomes for patients and families affected by this devastating disease.'.

“这个名称反映了我们的测试在改变阿尔茨海默病的诊断和管理方式方面的潜力，最终导致受这种毁灭性疾病影响的患者和家庭的预后得到改善。”。

'Focusing on shortening the time it takes to bring innovative assays to clinicians and patients is a core tenet of Danaher Diagnostics,' said

“专注于缩短为临床医生和患者带来创新检测所需的时间是Danaher Diagnostics的核心宗旨，”他说

Paul Beresford

保罗·贝雷斯福德

, Neurology Franchise Head, Danaher Diagnostics. 'This exciting announcement that Beckman Coulter's Access p Tau217/β-Amyloid 1-42 Plasma Ratio blood test received Breakthrough Device Designation from the FDA is another proof point demonstrating our progress in developing a portfolio of clinical diagnostics tests for neurodegenerative diseases, starting with Alzheimer's disease.

，Danaher Diagnostics神经病学特许经营主管。”贝克曼·库尔特（Beckman Coulter）的Access p Tau217/β-淀粉样蛋白1-42血浆比率血液测试获得了FDA的突破性设备指定，这一令人兴奋的宣布是另一个证据，证明了我们在开发神经退行性疾病临床诊断测试组合方面取得的进展，从阿尔茨海默氏病开始。

We believe that by taking such a disease-focused approach, Danaher Diagnostics and its operating companies are able to develop more innovative and patient-friendly clinical solutions.'.

我们相信，通过采取这种以疾病为中心的方法，Danaher Diagnostics及其运营公司能够开发出更具创新性和对患者友好的临床解决方案。”。

The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test measures the ratio of phosphorylated tau protein (p-Tau217) to β‑Amyloid 1-42, two key biomarkers implicated in the neurodegenerative processes of Alzheimer's disease. A blood-based IVD test that can quantify these biomarkers in plasma could provide a non-invasive, accessible, and earlier method of detecting Alzheimer's-related pathology.

Access p-Tau217/β-淀粉样蛋白1-42血浆比率血液测试测量磷酸化tau蛋白（p-Tau217）与β-淀粉样蛋白1-42的比率，β-淀粉样蛋白1-42是与阿尔茨海默病神经退行性过程有关的两个关键生物标志物。基于血液的IVD测试可以量化血浆中的这些生物标志物，可以提供一种非侵入性，可及性和早期检测阿尔茨海默氏病相关病理的方法。

This capability is important for improving early diagnosis, enabling timely intervention, and stratifying patients for therapeutic trials, ultimately accelerating progress in Alzheimer's research and treatment..

这种能力对于改善早期诊断，及时干预以及对患者进行治疗试验分层非常重要，最终加速阿尔茨海默病研究和治疗的进展。。

Orland

奥兰德

continued, 'Beyond the Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test, Beckman Coulter is committed to developing a full suite of next-generation neurodegenerative disease tests. The aging global population combined with emerging drug treatments is expected to create widespread demand for Alzheimer's disease testing, which will require accurate, high-throughput assays.

继续，“除了获得p-Tau217/β-淀粉样蛋白1-42血浆比例血液测试外，贝克曼·库尔特致力于开发一整套下一代神经退行性疾病测试。预计全球人口老龄化与新兴药物治疗相结合，将对阿尔茨海默病检测产生广泛需求，这将需要准确的高通量检测。

The proprietary technologies on the Beckman Coulter DxI 9000 Immunoassay Analyzer coupled with its novel Lumi-Phos PRO substrate has enabled development of precise, clinically relevant assays and shown capability to detect targeted neurological biomarkers on an automated, high-throughput platform.'.

Beckman Coulter DxI 9000免疫分析分析仪的专有技术及其新型Lumi Phos PRO底物能够开发精确的临床相关分析方法，并显示出在自动化高通量平台上检测靶向神经生物标志物的能力。”。

The FDA Breakthrough Device Designation program expedites the development and review of medical devices offering significant advancements in treating or diagnosing life-threatening or debilitating diseases. It provides prioritized review, enhanced communication, and regulatory support to help manufacturers bring innovative devices to market more efficiently, ultimately benefiting patients and public health..

FDA突破性设备指定计划加速了医疗设备的开发和审查，在治疗或诊断威胁生命或使人衰弱的疾病方面取得了重大进展。它提供优先审查、增强沟通和监管支持，以帮助制造商更有效地将创新设备推向市场，最终使患者和公共卫生受益。。

About Beckman Coulter

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams.

贝克曼·库尔特（BeckmanCoulter）是先进诊断领域的全球领导者，他对80多年来提高诊断实验室在改善患者健康方面的作用的公约提出了挑战。我们的使命是无情地重新想象医疗保健，一次一个诊断，我们通过运用科学、技术的力量以及团队的激情和创造力来做到这一点。

Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimized lab performance services.

我们的诊断解决方案用于复杂的临床测试，并在全球的医院、参考实验室和医生办公室环境中找到。我们的存在是为了提供更智能、更快的诊断解决方案，将指针从现在移动到下一步。我们寻求通过广泛的临床菜单，可扩展的实验室自动化技术，深入的临床信息学和优化的实验室性能服务来加速护理。

Headquartered in .

总部位于。

Brea, Calif.

布雷亚，加利福尼亚州。

, with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher. Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow's science and technology to improve human health.

Beckman Coulter Diagnostics拥有11000多名全球团队成员，很荣幸能成为Danaher的一员。达纳赫是全球科技领导者。我们共同努力，加速未来科学技术对现实生活的影响，以改善人类健康。

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