澳大利亚治疗用品管理局已批准pTau217血浆检测用于临床诊断，这是首个针对阿尔茨海默病的诊断性血液检测[1]。卫生部长Mark Butler将在悉尼启动亚太阿尔茨海默病诊断卓越中心，由澳洲神经科学研究所与罗氏公司合作运营[1]。该检测可在18分钟内完成[1]，诊断准确率约为90%[1]。
阿尔茨海默病是澳大利亚死亡的主要原因，目前估计有446,500名澳大利亚人患有痴呆症，其中约三分之二病例由阿尔茨海默病引起[1]。研究表明，淀粉样β和tau蛋白的变化在人们出现症状前的20至30年就已开始[1]。罗氏诊断公司董事总经理Anand Vairavan表示："早期诊断给了人们非常宝贵的东西，即时间"[1]。临床医生预计在6至9个月内能够转诊患者接受检测[1]。2024年10月，澳大利亚治疗用品管理局还批准了另一种血液检测pTau181[1]。
Australia's Therapeutic Goods Administration (TGA) has approved the pTau217 plasma test, marking the nation's first diagnostic blood test for Alzheimer's disease [1]. Health Minister Mark Butler will launch the Asia-Pacific Alzheimer's Disease Diagnostic Centre of Excellence in Sydney, a collaborative facility operated by the Neuroscience Research Australia (NeuRA) and Roche, which can complete the test in 18 minutes [1]. The diagnostic accuracy of the pTau217 test is approximately 90 percent [1].
The approval addresses a significant public health challenge in Australia, where Alzheimer's disease ranks among leading causes of death and an estimated 446,500 Australians currently live with dementia [1]. Alzheimer's disease accounts for approximately two-thirds of dementia cases [1]. Researchers emphasize that changes in amyloid-beta and tau proteins occur 20 to 30 years before symptoms appear [1], making early detection critical for intervention strategies. Clinicians are expected to be able to refer patients within six to nine months [1].
Anand Vairavan, Managing Director of Roche Diagnostics, underscored the significance of the breakthrough, stating that "early diagnosis gives people something incredibly valuable—time" [1]. The TGA previously approved another blood test, pTau181, in October 2024 [1]. The new diagnostic capability is anticipated to transform how Alzheimer's disease is detected, treated, and prevented in its early stages [1].