Labcorp a global leader of innovative and comprehensive laboratory services, announced today it will offer the Elecsys pTau181 test, the only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in the primary-care setting.

Labcorp 是创新和全面实验室服务的全球领导者，今天宣布将提供 Elecsys pTau181 测试，这是唯一获得美国食品药品监督管理局 (FDA) 批准的血液测试，用于在初级保健环境中帮助对阿尔茨海默病和其他认知能力下降原因进行初步评估。

Developed by Roche Diagnostics, Labcorp plans to make the test available nationwide by early 2026..

罗氏诊断公司开发，Labcorp计划在2026年初之前让这项测试在全国范围内可用。

An estimated 7.2 million Americans are living with Alzheimer's disease, a number expected to nearly double by 2050. Cognitive changes are often first identified during routine care visits, but Alzheimer's biomarker testing has traditionally required a specialist referral and advanced invasive testing.

据估计，美国有720万人患有阿尔茨海默病，预计到2050年这一数字将几乎翻倍。认知变化往往在常规护理访问期间首次被发现，但阿尔茨海默病的生物标志物检测传统上需要专家转诊和先进的侵入性测试。

The Elecsys pTau181 test is intended for adults ages 55 and older with signs, symptoms or complaints of cognitive decline. Clinicians can order the test to help rule out Alzheimer's-related amyloid pathology and identify patients who may benefit from further evaluation..

Elecsys pTau181测试适用于55岁及以上有认知能力下降迹象、症状或抱怨的成年人。临床医生可以要求进行该测试，以帮助排除与阿尔茨海默病相关的淀粉样蛋白病理，并确定可能受益于进一步评估的患者。

'Many patients presenting with cognitive symptoms don't have Alzheimer's disease, so helping clinicians rule it out can be just as critical as confirming it,' said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. 'As a leader in neurology with the broadest portfolio of Alzheimer's tests, Labcorp is proud to make the FDA-cleared Elecsys pTau181 test widely available—helping physicians identify the causes of cognitive decline and guide timely, appropriate care.'.

“许多出现认知症状的患者并没有阿尔茨海默病，因此帮助临床医生排除该病可能与确诊同样重要，”Labcorp 首席医学和科学官布莱恩·卡文尼博士表示。“作为神经病学领域的领导者，拥有最广泛的阿尔茨海默病检测产品组合，Labcorp 很自豪能够广泛提供经 FDA 批准的 Elecsys pTau181 检测——帮助医生识别认知衰退的原因，并指导及时、适当的治疗。”

Key Features of the Elecsys pTau181 Test

Elecsys pTau181 测试的关键特性

The Elecsys pTau181 test measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer's pathology, including amyloid plaque and tau aggregate pathology. According to Roche, clinical results demonstrated the test could rule out Alzheimer's pathology with a 97.9% negative predictive value (NPV).

Elecsys pTau181 检测试剂盒可测量人血浆中的磷酸化 Tau (pTau) 181 蛋白，这是阿尔茨海默病病理的关键生物标志物，包括淀粉样蛋白斑块和 tau 聚集病理。根据罗氏的说法，临床结果显示该测试可以以 97.9% 的阴性预测值 (NPV) 排除阿尔茨海默病病理。

A negative test result is consistent with a negative amyloid positron emission tomography (PET) scan result and reduced likelihood that a patient's cognitive impairment is due to amyloid pathology. These patients should be investigated for other causes of cognitive decline. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment. .

阴性检测结果与阴性淀粉样蛋白正电子发射断层扫描（PET）结果一致，表明患者认知障碍由淀粉样蛋白病理引起的可能性较低。应进一步检查这些患者是否存在其他导致认知能力下降的原因。初次检测结果呈阳性的患者应接受进一步检查，以确定淀粉样蛋白病理是否可能是导致认知障碍的原因。

Performed via a simple blood draw, the test offers an accessible, more affordable and less invasive alternative to traditional tests such as cerebrospinal fluid (CSF) testing obtained through lumbar puncture and PET scans. Once the test is ordered, the blood draw can be completed in a doctor's office or at any of Labcorp's more than 2,200 patient service centers (PSCs) nationwide..

通过简单的抽血进行，该测试提供了一个更易获取、更经济实惠且比传统测试（如通过腰椎穿刺获得的脑脊液（CSF）测试和PET扫描）更少侵入性的替代方案。一旦医生开出了这项测试，抽血可以在医生办公室或Labcorp遍布全国的2200多家患者服务中心（PSC）中的任何一家完成。

A Leader in Alzheimer's Testing

阿尔茨海默病检测领域的领导者

Labcorp's announcement underscores the company's commitment to expanding access to blood-based biomarkers for Alzheimer's disease testing. Since March 2023, Labcorp has offered a laboratory-developed test (LDT) version of pTau181, and in October 2023, added it to the company's ATN Profile — a panel combining three key biomarkers to identify and assess biological changes associated with Alzheimer's disease.

Labcorp的公告强调了公司致力于扩大阿尔茨海默病检测中基于血液的生物标志物的获取渠道。自2023年3月以来，Labcorp提供了一个实验室开发的pTau181测试版本，并在2023年10月将其添加到公司的ATN分析组合中——该组合结合了三个关键生物标志物，用于识别和评估与阿尔茨海默病相关的生物变化。

Most recently, Labcorp launched the FDA-cleared Lumipulse® pTau-217/Beta Amyloid 42 Ratio to aid in the diagnosis of Alzheimer's disease for use in specialty care settings..

最近，Labcorp 推出了经 FDA 批准的 Lumipulse® pTau-217/β淀粉样蛋白42比率检测，用于辅助诊断阿尔茨海默病，适用于专业护理环境。

For more information about Labcorp's portfolio of tests, visit https://www.labcorp.com/treatment-areas/neurology/conditions/neurodegenerative/alzheimers

有关Labcorp测试组合的更多信息，请访问 https://www.labcorp.com/treatment-areas/neurology/conditions/neurodegenerative/alzheimers

About Labcorp

关于Labcorp

Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities.

Labcorp（纽约证券交易所代码：LH）是创新和全面实验室服务的全球领导者，帮助医生、医院、制药公司、研究人员和患者做出清晰而自信的决策。我们通过无与伦比的诊断和药物开发实验室能力提供洞察力并推动科学发展，以改善健康状况、改善生活。

The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at www.labcorp.com..

该公司近7万名员工为大约100个国家的客户提供服务，为2024年FDA批准的新药和治疗产品中的75%以上提供了支持，并且每年为全球患者进行超过7亿次测试。更多信息，请访问www.labcorp.com。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警告声明

This press release contains forward-looking statements, including, but not limited to, statements with respect to the expected utility of and benefits to clinicians and patients of the Elecsys pTau181 test.

本新闻稿包含前瞻性陈述，包括但不限于关于 Elecsys pTau181 测试对临床医生和患者的预期效用和益处的陈述。

Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the company's control. These factors, in some cases, have affected and in the future (together with other factors) could affect the company's ability to implement the company's business strategy, and actual results could differ materially from those suggested by these forward-looking statements.

每项前瞻性声明均可能基于多种重要因素而发生变化，其中许多因素是公司无法控制的。在某些情况下，这些因素已经影响，并且未来（连同其他因素）可能会影响公司实施其业务战略的能力，实际结果可能与这些前瞻性声明所暗示的结果存在重大差异。

As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements..

因此，提醒读者不要对任何前瞻性声明给予过度依赖。

The company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company's most recent Annual Report on Form 10-K under the heading RISK FACTORS and in the company's other filings with the SEC.

公司即使在其预期发生变化的情况下，也没有义务对这些前瞻性声明提供任何更新。所有前瞻性声明均受此警示性声明的全面限制。有关可能影响经营和财务结果的潜在因素、风险和不确定性的更多信息，请参阅公司最近的年度报告 Form 10-K 中标题为“风险因素”的部分以及公司提交给美国证券交易委员会 (SEC) 的其他文件。

The information in this press release should be read in conjunction with a review of the company's filings with the SEC including the information in the company's most recent Annual Report on Form 10-K under the heading 'MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS'..

本新闻稿中的信息应与公司向美国证券交易委员会（SEC）提交的文件一起阅读，特别是公司最近的10-K表格年度报告中标题为“管理层对财务状况及经营结果的讨论与分析”部分的信息。

Source: prnewswire.com

来源：prnewswire.com