GENT, Belgium & MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes..

比利时根特（GENT）、宾夕法尼亚州马尔文（MALVERN）和东京（TOKYO）--（商业新闻短讯）--H。U、 集团控股公司及其全资子公司Fujirebio今天宣布，可用于全自动Lumipulse G免疫测定系统的Lumipulse G pTau 217血浆测定。这种CLEIA（化学发光酶免疫测定）测定法可以在35分钟内定量测量人K2EDTA血浆中苏氨酸217（pTau 217）磷酸化的Tau。。

“The launch of the pTau 217 Plasma assay on our fully automated LUMIPULSE platform is an essential step in the efforts of Fujirebio to bring novel, innovative neurodegenerative biomarkers to laboratories and clinicians around the world,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc.

Fujirebio Holdings，Inc.总裁兼首席执行官Goki Ishikawa表示：“在我们的全自动LUMIPULSE平台上推出pTau 217血浆检测是Fujirebio努力为世界各地的实验室和临床医生带来新颖创新的神经退行性生物标志物的重要一步。”。

“Expectations are high for this new biomarker, and researchers and clinical research professionals can now study its clinical utility on a platform that has the required throughput and meets the regulatory requirements to support possible future routine use.”.

“对这种新的生物标志物的期望很高，研究人员和临床研究专业人员现在可以在具有所需吞吐量并满足监管要求的平台上研究其临床实用性，以支持未来可能的常规使用。”。

About pTau 217

关于pTau 217

Current research indicates that plasma pTau, including pTau 217, is a predictor of amyloid status determined either by CSF1 or PET2, and therefore able to differentiate between Alzheimer’s disease (AD) and non-AD neurodegenerative diseases3,4 and to predict progression to AD.5,6 Blood-based biomarkers, such as plasma pTau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy in clinical trials, and could further advance the development and implementation of disease-modifying treatments in the field of AD and related disorders.7 This assay is designed to measure specifically the phosphorylation on position threonine 217 in human plasma..

目前的研究表明，血浆pTau（包括pTau 217）是由CSF1或PET2确定的淀粉样蛋白状态的预测因子，因此能够区分阿尔茨海默病（AD）和非AD神经退行性疾病3,4，并预测进展为AD.5,6血液生物标志物，如血浆pTau，可能被用作纳入标准或评估临床试验中的目标参与和治疗效果，并可能进一步推动AD和相关疾病领域疾病缓解治疗的发展和实施。7该测定法旨在专门测量人血浆中苏氨酸217位的磷酸化。。

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。

More information can be found at www.fujirebio.com/alzheimer..

更多信息请访问www.fujirebio.com/alzheimer。。

References:

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Mielke M, et al. Performance of plasma phosphorylated tau 181 and 217 in the community. Nat Med, 28(7): 1398-1405, 2022.

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Palmqvist S, et al. Discriminative accuracy of plasma phospho-tau 217 for Alzheimer’s disease vs other neurodegenerative disorders. JAMA, 324(8): 772-781, 2020.

Palmqvist S等人。血浆磷酸化tau 217对阿尔茨海默病与其他神经退行性疾病的鉴别准确性。JAMA，324（8）：772-7812020。

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