澳大利亚治疗商品管理局已批准一项名为pTau217的血液检测用于临床试验[1]。该检测由神经科学研究澳大利亚公司（NeuRA）与罗氏制药公司合作开发，能够在阿尔茨海默病症状出现前长达20年的时间内检测到相关迹象[1]。检测通过识别磷酸化tau 217蛋白这一淀粉样蛋白积累的生物标志物来工作，整个过程仅需约18分钟[1]。
NeuRA首席执行官Matthew Kiernan教授称这项批准是"阿尔茨海默病护理的新前沿"[1]。澳大利亚总理Anthony Albanese将这一宣布形容为"巨大突破"[1]。罗氏诊断澳大利亚总经理Anand Vairavan指出，当前的诊断方法"极其缓慢且复杂"[1]。
医生转诊患者进行该检测的推出预计将在未来6至9个月内开展[1]。痴呆症在澳大利亚已成为严重的公共卫生问题，2024年痴呆症导致超过17,500人死亡，成为该国首要死因[1]。痴呆症的年度成本已超过47亿澳元[1]。
Australia's medical regulator has cleared a blood-based test for clinical trials that could identify signs of Alzheimer's disease up to 20 years before symptoms appear [1]. The pTau217 test, developed through a collaboration between Neuroscience Research Australia (NeuRA) and pharmaceutical company Roche, received approval from the Therapeutic Goods Administration (TGA) [1]. The test works by detecting phosphorylated tau 217 protein, a biomarker of amyloid accumulation in the brain, and can deliver results in approximately 18 minutes [1].
Medical professionals have hailed the development as a significant breakthrough in Alzheimer's diagnosis [1]. NeuRA's chief executive, Professor Matthew Kiernan, described obtaining regulatory approval for the blood test as "a new frontier in Alzheimer's care" [1]. Roche Diagnostics Australia's general manager, Anand Vairavan, noted that current diagnostic methods are "extremely slow and complex" [1]. Physician referral pathways for the test are expected to launch within the next six to nine months [1].
The approval comes as Australia grapples with the rising burden of dementia, which claimed over 17,500 lives in 2024 and has become the nation's leading cause of death [1]. Annual costs associated with dementia have exceeded 4.7 billion Australian dollars [1]. Prime Minister Anthony Albanese described the announcement as a "massive breakthrough" [1].