Alzheimer's blood test that detects disease 20 years early approved for trials

A new blood test that can detect signs of Alzheimer's disease up to 20 years before symptoms emerge has been approved for clinical trials in Australia. The test, known as pTau217, identifies a protein biomarker linked to the buildup of amyloid plaque in the brain, a key factor in Alzheimer's.

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Having regulatory approval of these blood tests is a new frontier for Alzheimer's care.

Researchers announced the approval at the launch of the Asia-Pacific Centre of Excellence for Alzheimer's Disease Diagnosis in Sydney. This center, a collaboration between Neuroscience Research Australia (NeuRA) and Roche, aims to improve early and accurate detection through advanced blood tests. The Alzheimer's Association notes that Alzheimer's is the most common form of dementia in Australia, affecting memory, thinking, and behavior.

NeuRA stated the test would "alleviate the burden of delayed and uncertain diagnosis." The rollout for doctor referrals is expected within six to nine months. Professor Matthew Kiernan, NeuRA's CEO, called the regulatory approval a "new frontier for Alzheimer's care." The center is positioned to make New South Wales a national hub for dementia diagnostics and research.

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It's about the gift of time.

Currently, Alzheimer's diagnosis can be slow and complex, often requiring expensive imaging and invasive procedures. Roche Diagnostics Australia general manager Anand Vairavan highlighted that the new blood test offers "the gift of time." Federal Health Minister Mark Butler described finding a blood test for biomarkers as a "holy grail" for the disease, which caused over 17,500 deaths in Australia in 2024 and carries annual costs exceeding $4.7 billion.

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Finding a blood test for biomarkers is a holy grail for this disease.