ST. LOUIS & GENEVA, Switzerland--(BUSINESS WIRE)--Unilabs (“Unilabs”), a leading international provider of diagnostic services, and C2N Diagnostics, LLC (“C2N”), a pioneer in advanced diagnostic solutions in the field of Alzheimer’s disease (AD) and related neurological disorders, today announced a major milestone in brain health diagnostics and research across Europe and beyond..

瑞士圣路易斯和日内瓦——（商业新闻短讯）——国际领先的诊断服务提供商Unilabs（“Unilabs”）和阿尔茨海默氏病（AD）和相关神经系统疾病领域先进诊断解决方案的先驱C2N Diagnostics，LLC（“C2N”）今天宣布，这是欧洲及其他地区大脑健康诊断和研究的一个重要里程碑。。

Unilabs and C2N have signed a multi-year partnership agreement that will increase access to C2N’s Precivity portfolio of blood tests on an exclusive basis in Europe, including Norway, Switzerland, and the United Kingdom. The agreement will also provide access in Peru, Saudi Arabia, and the United Arab Emirates..

Unilabs和C2N签署了一项多年合作协议，该协议将在欧洲（包括挪威、瑞士和英国）独家增加对C2N血液检测精确性组合的访问。该协议还将为秘鲁、沙特阿拉伯和阿拉伯联合酋长国提供准入。。

“Alzheimer's disease is on the rise, making it essential to innovate by offering less invasive and more accessible diagnostic procedures for patients,” said Unilabs’ Head of Innovation Dr. Rahul Chaudhary. “All too often, diagnosing Alzheimer's has been painful, invasive and expensive. This partnership will transform the diagnostic experience for patients with cognitive concerns while revolutionizing early diagnosis, and research efforts, and positively impacting long-term outcomes.”.

Unilabs的创新负责人RahulChaudhary博士说：“阿尔茨海默病正在上升，因此必须通过为患者提供侵入性较小且更容易获得的诊断程序进行创新。”。“诊断阿尔茨海默氏病通常是痛苦的，侵入性的和昂贵的。这种合作关系将改变认知问题患者的诊断经验，同时彻底改变早期诊断和研究工作，并对长期结果产生积极影响。”。

He continued, “C2N’s Precivity portfolio of blood tests and its innovative biomarker pipeline offer the highest performance precision tools in the industry1. We expect these innovations to appeal to healthcare providers in Europe, the Gulf Region and Latin America who rely on us, and to our biopharma collaborators who are developing new therapies.

他继续说道：“C2N的血液检测精密组合及其创新的生物标志物管道提供了业界性能最高的精密工具1。我们希望这些创新能够吸引依赖我们的欧洲，海湾地区和拉丁美洲的医疗保健提供者，以及正在开发新疗法的生物制药合作者。

Patients worldwide deserve access to an early diagnosis, leveraging personalized medicine tools that can enable better treatment decisions and activate long-term disease prevention strategies. We are confident these tests can help in achieving better outcomes for patients, as we continue in our mission to power health and maximize life.”.

全世界的患者都应该获得早期诊断，利用个性化医疗工具，可以做出更好的治疗决策，并激活长期的疾病预防策略。我们相信这些测试可以帮助患者取得更好的结果，因为我们将继续致力于促进健康和最大限度地延长寿命。”。

C2N’s Precivity portfolio of blood tests aid healthcare providers and researchers in the detection of amyloid plaques and neurofibrillary “tau” tangles in the brain, which are pathological hallmarks of Alzheimer's disease. These tests also help to inform medical management and treatment decisions based on the underlying causes of dementia..

C2N的精确血液检测组合有助于医疗保健提供者和研究人员检测大脑中的淀粉样斑块和神经原纤维“tau”缠结，这是阿尔茨海默病的病理特征。这些测试还有助于根据痴呆症的根本原因为医疗管理和治疗决策提供信息。。

This strategic partnership also plans to facilitate a technology transfer of C2N’s proprietary portfolio of Alzheimer’s blood biomarkers to deliver a Unilabs testing network across Europe, ensuring Precivity testing can be performed at qualified healthcare institutions with the same quality, consistency and accuracy currently delivered at C2N’s central CAP/CLIA lab in St.

这一战略合作伙伴关系还计划促进C2N专有的阿尔茨海默氏病血液生物标志物组合的技术转让，以在欧洲各地提供Unilabs测试网络，确保可以在合格的医疗机构进行精确性测试，其质量，一致性和准确性与圣路易斯C2N中央CAP/CLIA实验室目前提供的相同。

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密苏里州路易斯。。

Both companies believe this partnership will transform global Alzheimer’s disease diagnosis for patients with cognitive concerns or at high risk of future AD or AD-related dementias.

两家公司都相信，这一合作关系将改变全球阿尔茨海默病患者的认知问题或未来AD或AD相关痴呆的高风险诊断。

Healthcare Sector Eager for Easy-to-Access, Less Invasive Tests

医疗保健部门渴望获得易于获取、侵入性较小的检测

C2N previously announced in 2020 that the PrecivityAD® blood test achieved the CE Mark from the European Union (EU) and also has In Vitro Diagnostic Regulation legacy device status under Regulation (EU) 2017/746, which allows for commercial availability in the EU as an in vitro diagnostic to aid in the evaluation of patients with mild cognitive impairment or dementia.

C2N之前于2020年宣布，PrecivityAD®血液测试达到了欧盟（EU）的CE标志，并且还具有2017/746法规（EU）下的体外诊断法规遗留设备状态，该法规允许在欧盟进行商业可用性作为体外诊断，以帮助评估轻度认知障碍或痴呆患者。

In addition, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency approved the PrecivityAD blood test as an in vitro diagnostic to aid in the diagnosis of Alzheimer's disease..

此外，英国药品和保健品管理局批准PrecivityAD血液检测作为体外诊断，以帮助诊断阿尔茨海默病。。

C2N CEO Dr. Joel Braunstein said, “The sobering impact of Alzheimer’s disease reaches beyond any one country’s borders and that’s why it’s vital we respond to the global interest in our Precivity blood tests. We believe this collaboration allows for the acceleration of equitable access to the highest quality blood biomarkers that can aid in the diagnosis of Alzheimer’s disease.

C2N首席执行官Joel Braunstein博士说：“阿尔茨海默氏病的严峻影响超越了任何一个国家的国界，这就是为什么我们必须应对全球对我们精确血液检测的兴趣。我们相信，这种合作可以加速公平获得最高质量的血液生物标志物，这些标志物可以帮助诊断阿尔茨海默氏病。

To date, we’ve secured other international arrangements, and now, we’re very proud to enter this multi-faceted strategic affiliation with Unilabs, an organization that places a premium on quality in testing and in personalized diagnostics for Alzheimer’s disease.”.

迄今为止，我们已经获得了其他国际安排，现在，我们非常自豪地与Unilabs建立了多方面的战略合作关系，Unilabs是一个重视阿尔茨海默病检测和个性化诊断质量的组织。”。

The PrecivityAD2™ and PrecivityAD blood tests use highly sensitive and specialized laboratory technologies to identify and measure certain proteins that are found in the blood and that are known to be associated with the presence of brain amyloid plaques, one of the brain pathology findings of Alzheimer’s disease.

PrecivityAD2™和PrecivityAD血液测试使用高度敏感和专业的实验室技术来识别和测量血液中发现的某些蛋白质，这些蛋白质已知与脑淀粉样斑块的存在有关，脑淀粉样斑块是阿尔茨海默病的脑病理学发现之一。

The main test result is a clinically validated score that determines a patient’s likelihood category for the presence of brain amyloid plaques. Like other tests that evaluate for brain amyloid pathology in clinical patients, such as amyloid PET scan or cerebrospinal fluid (CSF) testing, the Precivity blood tests can be used by healthcare providers to interpret the test results, along with other medical information..

主要测试结果是经过临床验证的评分，该评分确定了患者存在脑淀粉样斑块的可能性类别。与评估临床患者脑淀粉样蛋白病理的其他测试（例如淀粉样蛋白PET扫描或脑脊液（CSF）测试）一样，医疗保健提供者可以使用Precivity血液测试来解释测试结果以及其他医学信息。。

The tests are intended for use in patients 55 years and older with signs or symptoms of mild cognitive impairment or dementia. These tests are only available for order by qualified healthcare providers.

这些测试旨在用于55岁及以上有轻度认知障碍或痴呆症状或体征的患者。这些测试只能由合格的医疗保健提供者订购。

C2N and Unilabs expect the Precivity portfolio of blood tests will become available to Unilabs customers over the coming months, depending on geographic region. To inquire further about timelines for a specific country please email globalinfo@c2n.com or globalinfo@unilabs.com.

C2N和Unilabs预计，Unilabs的客户将在未来几个月内根据地理区域的不同，提供精确的血液检测组合。要进一步了解特定国家的时间表，请发送电子邮件globalinfo@c2n.com或globalinfo@unilabs.com.

About C2N Diagnostics, LLC

关于C2N Diagnostics，LLC

C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health.

C2N是一家专业诊断公司，其愿景是通过Innovation®实现清晰。C2N致力于在大脑健康领域提供卓越的临床实验室服务和先进的诊断解决方案。C2N基于高分辨率质谱的生物标志物服务和产品用于：改善患者护理的临床决策，包括诊断和治疗监测；最大限度地提高测试神经退行性疾病新疗法的临床试验的质量和效率；并提供创新工具，帮助医疗保健研究人员更好地了解新的疾病机制，确定新的治疗目标，并进行重要的流行病学研究，以改善全球公共卫生。

C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums.

C2N分析已在美国和世界各地的150多个阿尔茨海默氏病和其他研究中使用。这包括具有里程碑意义的治疗和预防试验，涉及改变阿尔茨海默病轨迹的疾病缓解疗法（DMT）。C2N与跨国制药和生物技术公司、领先学术机构、国家老龄研究所、阿尔茨海默氏病协会以及其他非营利组织和财团正在进行合作。

Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes.

通过同行评审的出版物报告了超过30000种与Precivity™相关的生物标志物测量方法，目前正在审查更多的手稿。C2N与世界各地众多领先的临床诊断实验室合作，为提供者和患者提供扩展的Precivity™测试，包括巴西的Grupo Fleury和澳大利亚的Healius Pathology用于临床，以及日本的Mediford Corporation用于研究目的。

C2N also recently announced it has entered into a non-exclusive agreement with Mayo Clinic Laboratories..

C2N最近还宣布，它已与梅奥诊所实验室签订了非排他性协议。。

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com.

该公司感谢美国国家老龄化研究所、GHR基金会、阿尔茨海默病药物发现基金会、阿尔茨海默病协会和BrightFocus基金会的慷慨支持。有关更多信息，请访问www.C2N.com。

About Unilabs

关于Unilabs

Unilabs is a leading international provider of diagnostic services offering a complete range of laboratory, pathology, genetics and imaging services to patients across four continents.

Unilabs是一家领先的国际诊断服务提供商，为四大洲的患者提供全方位的实验室、病理学、遗传学和影像学服务。

With over 13,000 people in 15 countries, Unilabs invests heavily in technology, equipment and people — using digital technologies in its state-of-the-art laboratories and imaging institutes — to improve the lives of close to 100 million people every year. For more information visit www.unilabs.com

Unilabs在15个国家拥有13000多人，在技术、设备和人员方面进行了大量投资，在其最先进的实验室和成像机构中使用数字技术，每年改善近一亿人的生活。有关更多信息，请访问www.unilabs.com

Key publications on the Precivity Portfolio of Tests, more at www.precivityad.com/publications-clinical-use.

有关精确性测试组合的关键出版物，请访问www.precivityad.com/publications-clinical-use。

PrecivityAD2

精确度2

Palmqvist S, Tideman P, Mattsson-Carlgren N, et al. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care. JAMA, 2024. https://doi:10.1001/jama.2024.13855

Palmqvist S，Tideman P，Mattsson-Carlgren N等人。在初级保健和二级保健中检测阿尔茨海默病的血液生物标志物。JAMA，2024年。https://doi:10.1001/jama.2024.13855

Matthew R. Meyer, Kristopher M. Kirmess, et.al. Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Aβ42/40 ratio to identify presence of brain amyloid. Alzheimer’s Dement, 2024. https://doi.org/10.1002/alz.13764

Matthew R.Meyer，Kristopher M.Kirmess等。PrecivityAD2血液测试的临床验证：基于质谱的测试，结合%p-tau217和Aβ42/40比率的算法来识别脑淀粉样蛋白的存在。阿尔茨海默病痴呆症，2024年。https://doi.org/10.1002/alz.13764

PrecivityAD

精密度

Hu Y, Kirmess KM, Meyer MR, et al. Assessment of a plasma amyloid probability score to estimate amyloid positron emission tomography findings among adults with cognitive impairment. JAMA Netw Open. 2022; 2022. doi:10.1001/jamanetworkopen.2022.8392

Hu Y，KirmessKM，Meyer MR等。评估血浆淀粉样蛋白概率评分，以估计认知障碍成年人的淀粉样正电子发射断层扫描结果。JAMA网络打开。2022年；doi:10.1001/jamanetworkopen.2022.8392

Fogelman I, West T, Braunstein JB, et al. Independent study demonstrates amyloid probability score accurately indicates amyloid pathology. Ann Clin Transl Neurol, 2023. doi.org/10.1002/acn3.51763

Fogelman I，West T，Braunstein JB等人。独立研究表明淀粉样蛋白概率评分准确地指示淀粉样蛋白病理。Ann Clin Transl Neurol，2023年。doi.org/10.1002/acn3.51763

Monane MM, Johnson KG, Snider, BJ, et al. A blood biomarker test for brain amyloid impacts clinical decision making among memory specialists in the evaluation of cognitive impairment. Ann Clin Transl Neurol, 2023. http://doi.org/10.1002/acn3.51863

Monane MM，Johnson KG，Snider，BJ等。大脑淀粉样蛋白的血液生物标志物测试会影响记忆专家在评估认知障碍方面的临床决策。Ann Clin Transl Neurol，2023年。http://doi.org/10.1002/acn3.51863

Canestaro et al, Use of a Blood Biomarker Test Improves Economic Utility in the Evaluation of Older Patients Presenting with Cognitive Impairment; Population Health Management, 2023. https://doi.org/10.1089/pop.2023.0309

Canestaro等人，使用血液生物标志物测试可以提高评估患有认知障碍的老年患者的经济效用；人口健康管理，2023年。https://doi.org/10.1089/pop.2023.0309

Head-to-head technology comparisons of blood biomarkers for Alzheimer’s disease1

阿尔茨海默病血液生物标志物的头对头技术比较1

Janelidze et al. Head-to-head comparison of 10 plasma phosphor-tau assays in prodromal Alzheimer’s disease. Brain, 2023. https://doi.org/10.1093/brain/awac333

Janelidze等人。前驱阿尔茨海默病中10种血浆磷tau测定的头对头比较。大脑，2023年。https://doi.org/10.1093/brain/awac333

Janelidze et al. Head-to-head comparison of 8 plasma amyloid-beta 42/40 assays in Alzheimer’s disease. JAMA Neurology, 2021. https://jamanetwork.com/journals/jamaneurology/fullarticle/2784411

Janelidze等。阿尔茨海默病中8种血浆淀粉样蛋白β42/40测定的头对头比较。JAMA神经病学，2021年。https://jamanetwork.com/journals/jamaneurology/fullarticle/2784411

Schindler, et al. Effect of Race on Prediction of Brain Amyloidosis by Plasma Aβ42/Aβ40, Phosphorylated Tau, and Neurofilament Light. Neurology, 2022. https://doi.org/10.1212/WNL.0000000000200358

Schindler等人。种族对血浆Aβ42/Aβ40，磷酸化Tau和神经丝光预测脑淀粉样变性的影响。神经病学，2022年。https://doi.org/10.1212/WNL.0000000000200358