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罗氏阿尔茨海默病检测法Elecsys PTau217获FDA突破性设备认定

Roche's Elecsys PTau217 Blood Test Receives FDA Breakthrough Designation For Alzheimer's Detection

RTTNews 等信源发布 2024-04-11 13:22

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Roche (RHHBY) said that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration.The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company.Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer's disease, Roche said.Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer's diagnosis..

罗氏(RHHBY)表示,其Elecsys pTau217检测获得了美国食品和药物管理局的突破性设备指定。Elecsys pTau217血浆生物标志物测试正在开发中,作为罗氏和礼来公司之间持续合作的一部分。罗氏说,一旦获得批准,该测试将帮助医疗保健提供者识别淀粉样蛋白病理学,这是阿尔茨海默病的一个关键特征。罗氏公司和礼来公司认为,这项测试可能在改善早期准确诊断阿尔茨海默病方面发挥重要作用。。

Roche noted that pTau217, which is a phosphorylated fragment of the protein tau, is a biomarker that has shown the ability in research settings to distinguish Alzheimer's disease from other neurodegenerative disorders and has shown strong performance relative to other biomarkers.For More Such Health News, visit rttnews.com.

罗氏指出,pTau217是tau蛋白的磷酸化片段,是一种生物标志物,在研究环境中显示出将阿尔茨海默病与其他神经退行性疾病区分开来的能力,并且相对于其他生物标志物表现出强大的性能。欲了解更多此类健康新闻,请访问rttnews.com。