MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--Fujirebio today announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S.

宾夕法尼亚州马尔文（MALVERN）和东京（BUSINESS WIRE）--Fujirebio今天宣布，其全资子公司Fujirebio Diagnostics，Inc.已向美国食品和药物管理局（FDA）提交了Lumipulse®G pTau 217/β-淀粉样蛋白1-42血浆比体外诊断（IVD）测试。新的血浆测试有望成为美国第一个商业上可获得的基于血液的IVD测试。

to help in the assessment of Alzheimer’s disease (AD)..

帮助评估阿尔茨海默病（AD）。。

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, which received Breakthrough Device Designation from the FDA, is an IVD test using measurable pTau 217 and β-Amyloid 1-42 concentrations found in human plasma. The test combines these concentrations into a numerical ratio of pTau 217/β-Amyloid 1-42 to identify patients with amyloid pathology associated with AD.

Lumipulse G pTau 217/β-淀粉样蛋白1-42血浆比率是一种IVD测试，使用人血浆中可测量的pTau 217和β-淀粉样蛋白1-42浓度。该测试将这些浓度结合到pTau 217/β-淀粉样蛋白1-42的数字比率中，以鉴定与AD相关的淀粉样蛋白病理学患者。

β-Amyloid neuritic plaque pathology in the brain is believed to contribute to the loss of cognitive function that characterizes AD..

大脑中的β-淀粉样神经炎斑块病理被认为是导致AD特征性认知功能丧失的原因。。

AD is a devastating condition that afflicts more than 6 million Americans and is a leading cause of disability and death. Access to reliable diagnostic tools is currently limited. Diagnosis involves a variety of subjective measures and costly or invasive procedures, such as amyloid positron emission tomography (PET) scans and cerebral spinal fluid (CSF) tests.

。目前，对可靠诊断工具的访问受到限制。诊断涉及多种主观测量和昂贵或侵入性程序，例如淀粉样正电子发射断层扫描（PET）扫描和脑脊液（CSF）测试。

As a result, many patients are not diagnosed until their disease has advanced, limiting the benefits of available treatment options..

因此，许多患者直到疾病进展才被诊断出来，限制了可用治疗选择的益处。。

The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s fully automated Lumipulse G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022..

Lumipulse pTau 217/β-淀粉样蛋白1-42血浆比率测试使用Fujirebio的全自动Lumipulse G1200仪器系统，该系统在美国各地的临床实验室中广泛使用。新的比率测试补充了Lumipulse Gβ-淀粉样蛋白比率（1-42/1-40），该比率由FDA授权于2022年5月用于脑脊液。。

“The lack of effective and accessible diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. “We designed our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test to help physicians and patients with signs and symptoms of cognitive decline obtain an AD diagnosis much earlier when interventions are more effective.

Fujirebio diagnostics，Inc.总裁兼首席执行官Monte Wiltse说：“AD缺乏有效且可获得的诊断方法，导致其诊断较晚和治疗不足。我们设计了Lumipulse G pTau 217/β-淀粉样蛋白1-42血浆比率测试，以帮助有认知能力下降体征和症状的医生和患者在干预措施更有效时更早地获得AD诊断。

An early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally. As part of our worldwide commitment to improving the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”.

早期准确的诊断也将有助于开发新的药物疗法，随着全球人口迅速老龄化，AD的患病率增加，迫切需要新的药物疗法。作为我们在全球范围内致力于改善AD诊断和治疗的一部分，Fujirebio正在开发其他检测方法，这将增加诊断工具的可用性，并为早期更有效的治疗奠定基础。”。

About Fujirebio

关于Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.

Fujirebio是H.U.Group Holdings Inc.的成员，是高质量体外诊断（IVD）测试领域的全球领导者。它在强大的IVD产品的概念，开发，生产和全球商业化方面拥有50多年的积累经验。

Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools.

25年前，Fujirebio是第一家以Innogenetics品牌开发和销售CSF生物标志物的公司。Fujirebio仍然是唯一一家拥有如此全面的手动和全自动神经退行性疾病检测系列的公司，并始终与世界各地的组织和临床专家合作，为更早，更容易和更完整的神经退行性诊断工具开发新途径。

About Fujirebio Diagnostics, Inc.

关于Fujirebio Diagnostics，Inc。

Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

Fujirebio Diagnostics，Inc.是Fujirebio Holdings，Inc.的全资子公司，是首屈一指的癌症诊断公司，也是癌症生物标志物检测领域的行业领导者。该公司在25年前率先推出了CA125测试，这是FDA批准的第一个卵巢癌生物标志物。Fujirebio Diagnostics专门从事用于管理人类疾病状态的体外诊断产品的临床开发，制造和商业化，重点是肿瘤学。