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pTau1811。
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.
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