Diagnostics giant Roche is putting its weight behind a biomarker for Alzheimer’s disease developed by ALZpath.

诊断巨头罗氏（Roche）正全力支持ALZpath开发的阿尔茨海默病生物标志物。

The Swiss group has taken a license to use an antibody developed by ALZpath against a form of phosphorylated tau protein – pTau217 – for the development and commercialisation of a blood test for Alzheimer’s.

这家瑞士集团已获得许可，可以使用ALZpath开发的针对一种磷酸化tau蛋白（pTau217）的抗体来开发和商业化阿尔茨海默氏病的血液检测。

Studies have suggested that detecting pTau217 in blood samples may be able to identify people at elevated risk for developing Alzheimer’s years before they develop any cognitive symptoms. It also has the potential to distinguish Alzheimer’s from other neurodegenerative disorders, and was recently awarded breakthrough status by the FDA..

研究表明，检测血液样本中的pTau217可能能够在人们出现任何认知症状之前的几年内识别出患有阿尔茨海默病的高风险人群。它还具有将阿尔茨海默病与其他神经退行性疾病区分开的潜力，最近被FDA授予突破性地位。。

At the moment, AD is typically diagnosed with the help of time-consuming and expensive PET brain scans or invasive cerebrospinal fluid (CSF) analysis carried out by lumbar puncture, coupled with cognitive testing.

目前，AD通常是通过耗时且昂贵的PET脑部扫描或腰椎穿刺进行的侵入性脑脊液（CSF）分析以及认知测试来诊断的。

All of these tests can be hard to access for patients, which contributes to the current situation where almost four in 10 people with dementia do not have a diagnosis, according to the Alzheimer’s Society.

根据阿尔茨海默氏症协会的数据，所有这些测试对于患者来说都很难获得，这导致了目前几乎十分之四的痴呆症患者没有诊断。

Blood assays employing the pTau217 antibody have demonstrated comparable accuracy to PET imaging or CSF testing, according to ALZpath, but offer “the affordability and convenience of a simple, less invasive blood test.”

根据ALZpath的说法，使用pTau217抗体的血液检测已经证明与PET成像或CSF检测具有相当的准确性，但提供了“简单，侵入性较小的血液检测的经济性和便利性”

Roche – which has a collaboration with Eli Lilly on the development and commercialisation of blood tests for Alzheimer’s – aims to develop a test for pTau217 for its widely-used Elecsys analyser platform.

罗氏公司（Roche）与礼来公司（Eli Lilly）合作开发阿尔茨海默氏症（Alzheimer's）血液测试并将其商业化，旨在为其广泛使用的Elecsys分析仪平台开发pTau217测试。

An FDA advisory committee has just unanimously voted in favour of Lilly’s anti-amyloid Alzheimer’s therapy donanemab, setting up a possible approval later this year.

FDA咨询委员会刚刚一致投票支持礼来公司的抗淀粉样阿尔茨海默氏病药物donanemab，并可能在今年晚些时候获得批准。

In time, an effective blood test will be invaluable for selecting patients who may benefit from therapies like donanemab and Eisai and Biogen’s already-approved Leqembi (lecanemab), as well as to recruit patients into clinical trials of new drug candidates.

随着时间的推移，有效的血液检测对于选择可能受益于donanemab和Eisai以及Biogen已经批准的Leqembi（lecanemab）等疗法的患者以及招募患者参加新药候选药物的临床试验将是非常宝贵的。

Incorporating pTau217 into Elecys could “help transform Alzheimer’s disease research, accelerate the evaluation of promising interventions to treat and prevent the disease, and improve the assessment and care of people with memory problems,” said ALZpath advisor Sterling Johnson.

ALZpath顾问斯特林·约翰逊（Sterling Johnson）说，将pTau217纳入Elecys可以“帮助改变阿尔茨海默病的研究，加速对治疗和预防疾病的有希望的干预措施的评估，并改善对记忆问题患者的评估和护理”。

“With time, the test could ultimately be used to screen and to help avert the clinical onset of Alzheimer’s disease when effective prevention therapies become available,” he added.

他补充说：“随着时间的推移，当有效的预防疗法可用时，该测试最终可以用于筛查并帮助避免阿尔茨海默病的临床发作。”。

The company already markets a version of the test under the ALZpath Dx brand in the US, which has been adopted for use by various clinical testing laboratories including Neurocode USA and Alamar Biosciences.

该公司已经在美国销售了ALZpath Dx品牌的测试版本，该版本已被包括Neurocode USA和Alamar Biosciences在内的各种临床测试实验室采用。