New Blood Test for Alzheimer’s Approved in Australia
31 Jul 2026
The test is expected to support earlier diagnosis in people with cognitive symptoms and may eventually become available through Medicare once Australian clinical evidence is established.
The Federal Government announced that Roche Diagnostics has received TGA approval to supply the phosphorylated tau 217 (pTau217) blood test. The test is designed to help rule in or rule out Alzheimer’s disease pathology by identifying proteins linked to the condition.
Health and Ageing Minister Mark Butler described the blood test as an important breakthrough for earlier diagnosis, saying it could provide patients with answers more quickly when they experience changes in memory or thinking.
The approval follows last year's authorisation of the pTau181 blood test, which helps rule out Alzheimer’s disease in people with cognitive symptoms.
The Government also officially opened the Asia-Pacific Centre of Excellence for Alzheimer’s Disease Diagnosis in Sydney. The centre, a partnership between Neuroscience Research Australia (NeuRA) and Roche Diagnostics Australia, will process the newly approved pTau217 test, the pTau181 test, and ApoE4 testing used in Alzheimer’s research and diagnosis.
Associate Professor Emma Devenney, neurologist and researcher at NeuRA, said blood-based biomarkers could provide faster diagnoses while avoiding more invasive procedures.
Currently, confirming Alzheimer’s disease usually requires a PET scan or a lumbar puncture to test cerebrospinal fluid. These methods can be expensive, difficult to access outside major cities, and more invasive. According to Associate Professor Devenney, the new blood tests have demonstrated accuracy similar to these existing diagnostic methods.
The tests will initially be used in clinical trials and research. Clinical use by specialists is expected to begin in the coming months, with provisional availability anticipated from October 2026.
The Government hopes Australian clinical data generated through the Centre of Excellence will support a future application for a Medicare Benefits Schedule (MBS) item, making the test more accessible to patients.
Dr Stephanie Daly, Chair of the RACGP Specific Interests Dementia Sub-Group, called the development a major milestone but advised GPs to use the tests carefully.
She said the blood tests are more affordable and accessible than current diagnostic methods, but they only detect one type of Alzheimer’s pathology. GPs should complete a thorough clinical assessment, consider other possible causes of cognitive changes, and understand how to interpret the results before using the tests.
Dr Daly also advised that the tests should not be used in people without symptoms because there is currently limited evidence about their accuracy in this group. She encouraged GPs to undertake education and training before introducing the tests into practice.
Associate Professor Devenney said patients concerned about memory or thinking changes can be referred to a specialist, who may decide whether blood testing is appropriate. She added that the blood test should be used alongside cognitive assessments rather than as a standalone diagnostic tool.
The long-term goal is to generate enough Australian evidence to support Medicare funding and improve access to earlier Alzheimer’s disease diagnosis across the country.
New Blood Test for Alzheimer’s Approved in Australia
Source: newsGP