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.
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