Quest Diagnostics将提供 FDA批准的富士瑞生物阿尔茨海默病血液检测-动脉网

Quest Diagnostics to Offer FDA-Cleared Fujirebio Blood Test for Alzheimer's Disease

CISION 等信源发布 2025-07-09 20:24

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Test to be available for clinical and research use as soon as this summer, building on Quest's pioneering blood-based AD-Detect™ product line for assessing symptomatic patients

测试将于今年夏天尽快用于临床和研究，基于Quest公司开创性的基于血液的AD-Detect™产品线，用于评估有症状的患者。

SECAUCUS, N.J.

新泽西州塞考克斯

，

July 9, 2025

2025年7月9日

/PRNewswire/ -- Quest Diagnostics (NYSE:

/PRNewswire/ -- Quest Diagnostics (纽约证券交易所代码:

DGX

), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced it plans to offer laboratory testing based on the

），一家在诊断信息服务领域的领导者，包括大脑健康先进诊断，今天宣布计划提供基于实验室的测试服务。

Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio

Lumipulse® G pTau 217/β-淀粉样蛋白1-42血浆比率

in-vitro

体外

diagnostic (IVD) test from Fujirebio, a global leader in the field of high-quality IVD testing.

来自富士瑞比奥的诊断（IVD）测试，该公司是高品质IVD检测领域的全球领导者。

Quest plans to make the test available to physicians and biopharmaceutical collaborators later this summer. The test is the first blood-based IVD test cleared by the U.S. Food and Drug Administration (FDA) to aid in identifying patients with amyloid pathology associated with Alzheimer's disease. It is designed to aid the clinical assessment of Alzheimer's disease in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline..

Quest计划在今年夏末将该测试提供给医生和生物制药合作伙伴。该测试是首个由美国食品和药物管理局（FDA）批准的基于血液的体外诊断（IVD）测试，用于帮助识别与阿尔茨海默病相关的淀粉样蛋白病理的患者。它旨在辅助临床评估50岁及以上在专业护理环境中表现出认知能力下降迹象和症状的成年患者的阿尔茨海默病。

Through its AD-Detect™ portfolio, Quest provides a suite of advanced lab-developed blood tests regulated under CLIA for assessing patients with cognitive impairment for Alzheimer's disease. The Fujirebio test offering extends this portfolio to include an FDA-cleared option for use in specialized care settings..

通过其AD-Detect™产品组合，Quest提供了一套先进的实验室开发的血液检测方法，这些方法受CLIA监管，用于评估有认知障碍的阿尔茨海默病患者。Fujirebio的测试产品进一步扩展了这一组合，包含了一个FDA批准的选项，可用于专业护理环境。

'Our goal is to advance access to quality and innovative blood-based tests for Alzheimer's disease. Adding the Fujirebio test to our existing blood-based tests provides the many physicians we serve with another powerful option for assessing patients for Alzheimer's disease,' said

“我们的目标是推动获取高质量和创新的基于血液的阿尔茨海默病检测方法。将富士瑞生物测试加入我们现有的基于血液的测试中，为我们服务的众多医生提供了另一种强大的评估患者阿尔茨海默病的选项，”

Kathleen Valentine

凯瑟琳·瓦伦丁

, Vice President and General Manager, Neurology, Quest Diagnostics. 'Blood-based testing can be less invasive and more convenient than traditional test methods. We are excited to leverage our expansive network of patient service centers to broaden access to the Fujirebio innovation to help more at-risk individuals gain access to the insights they need sooner.'.

Quest诊断公司神经病学副总裁兼总经理表示：“基于血液的检测可能比传统检测方法更少侵入性且更方便。我们很高兴利用我们广泛的患者服务中心网络，扩大对富士瑞生物创新技术的访问，帮助更多高危人群更快获得他们所需的洞察。”

In a clinical study population of 499 patients, which closely mirrors US demographics, and when applying a dual cut point, the FDA-cleared test demonstrated a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97%, with 20% of patients uncertain to have amyloid pathology, thus requiring further testing..

在一项包含499名患者、紧密反映美国人口统计特征的临床研究人群中，当应用双重临界值时，FDA批准的测试显示出92%的阳性预测值（PPV）和97%的阴性预测值（NPV），其中20%的患者不确定是否患有淀粉样蛋白病理，因此需要进一步检测。

Quest will showcase its complete line up of Alzheimer's and other neurological test innovations at this year's Alzheimer's Association International Conference (AAIC) in

Quest将在今年的阿尔茨海默病协会国际会议（AAIC）上展示其完整的阿尔茨海默病和其他神经系统测试创新产品线。

Toronto

多伦多

from

从

July 27-31

7月27日至31日

。

'As brain health and Alzheimer's disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical,' said

“随着大脑健康和阿尔茨海默病干预措施的不断发展，在干预最有效的早期阶段诊断患者至关重要，”

Michael Racke

迈克尔·拉克

, MD, a board-certified neurologist and Medical Director of Neurology, Quest Diagnostics. 'We are constantly looking for ways to help physicians and patients make the most informed decisions, and this new addition to our test menu will aid that goal.'

医学博士，神经病学委员会认证专家，Quest Diagnostics神经病学科医学主任。“我们一直在寻找帮助医生和患者做出最明智决策的方法，我们测试菜单的这一新成员将有助于实现这一目标。”

While amyloid PET imaging and cerebral spinal fluid testing are established methods for aiding the diagnosis of Alzheimer's disease, they are significantly more expensive, invasive and specialist-dependent than blood-based tests. With a physician's order, patients can conveniently provide a blood draw for testing for the Fujirebio test and any of the AD-Detect™ tests through Quest's network of patient sites.

虽然淀粉样蛋白 PET 成像和脑脊液检测是辅助诊断阿尔茨海默病的成熟方法，但它们比基于血液的检测明显更昂贵、更具侵入性且更依赖于专家。凭借医生的指示，患者可以通过 Quest 的患者站点网络方便地提供血液样本，进行 Fujirebio 检测或任何 AD-Detect™ 检测。

Quest maintains approximately 8,000 patient access points, including an extensive patient service center network of approximately 2,000 locations in the U.S., as well as phlebotomists in physician offices and mobile phlebotomy services. Specimens will be transported for testing to Quest's state-of-the-art laboratory in .

Quest维护着大约8,000个患者接入点，其中包括一个由约2,000个地点组成的广泛患者服务中心网络，以及在医生办公室和移动采血服务中的采血师。样本将被运送到Quest位于的最先进的实验室进行测试。

San Juan Capistrano, California

加利福尼亚州圣胡安卡皮斯特拉诺

。

Nearly

接近地

7 million Americans

700万美国人

have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Approximately

患有阿尔茨海默病，这是最常见的痴呆类型，预计到2060年这一数字将达到1400万。大约

12-18% of adults

12%-18%的成年人

over the age of sixty are living with mild cognitive impairment, a potential sign of AD. Seventy-seven percent of physicians say new therapies will transform Alzheimer's into a chronic, manageable disease, and 94% of physicians say blood tests would be more cost effective for the healthcare system compared to more invasive methods of detection (e.g., lumbar puncture, imaging studies) according to .

六十岁以上的人患有轻度认知障碍，这是阿尔茨海默病的潜在征兆。77%的医生表示，新的疗法将使阿尔茨海默病转变为一种慢性、可控制的疾病，94%的医生认为，与更具侵入性的检测方法（例如腰椎穿刺、影像学检查）相比，血液测试对医疗系统来说更具成本效益。

a special report from Quest

Quest特别报告

。

Quest is committed to developing and offering innovative advanced diagnostics to aid in evaluating Alzheimer's disease and other brain diseases. For more information, visit

Quest致力于开发和提供创新的先进诊断技术，以帮助评估阿尔茨海默病和其他脑部疾病。欲了解更多信息，请访问

www.QuestForTheCure.com

。

About Quest Diagnostics

关于Quest诊断公司

Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management.

Quest Diagnostics致力于在医疗保健生态系统中创造一个更加健康的世界，一次改变一个生命。我们通过实验室检测结果提供诊断见解，帮助个人、医生和机构采取行动改善健康结果。Quest的诊断洞察源自全球最大的去标识化临床实验室结果数据库之一，揭示了识别和治疗疾病的新途径，激励健康行为并改善医疗管理。

Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in .

Quest Diagnostics每年为三分之一的美国成年人和一半的医生及医院提供服务。

the United States

美国

, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world.

，我们的近55,000名员工深知，在正确的手中并结合适当的背景，我们的诊断洞察可以激发改变生命、创造更健康世界的行动。

www.QuestDiagnostics.com

。

SOURCE Quest Diagnostics

来源：奎斯特诊断公司

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