The federal health minister has high hopes for the newly approved blood test for detecting signs of dementia.
On Thursday the Therapeutic Goods Administration announced the approval of a new blood test that can detect dementia-related changes in the brain decades before symptoms appear.
The test detects the phosphorylated tau 217 protein – a biomarker for the build-up of amyloid plaque in the brain – and is reported to give results in as little as 18 minutes. Amyloid plaques are thought to play a key role in the pathology underlying Alzheimer’s disease, the most common form of dementia in the country.
“The clinical research studies so far show the p-Tau 217 blood test is so far the most accurate and reliable diagnostic marker for Alzheimer’s disease,” cognitive neurologist and researcher Emma Devenney told the ABC.
“It’s on par with other more invasive testing as well as CT pet scans. So, we really are looking at an opportunity to do a single blood test to make that Alzheimer’s disease diagnosis, with over 90% accuracy.”
Prime Minister Anthony Albanese told ABC News Breakfast that the test “could be a massive breakthrough”.
“This breakthrough today is really important and provides hope at a time where, I think the world needs more hope and less fear.”
Diagnostic equipment and reagent manufacturing company Roche Diagnostics has been authorised to supply the new p-Tau217 test.
The timing of the announcement aligned with federal health minister Mark Butler opening the Asia Pacific Centre for Excellence in Alzheimer’s Disease Diagnosis in Sydney, a collaboration between Neuroscience Research Australia (NeuRA) and Roche.
Mr Butler described the new test as the “holy grail” in dementia diagnosis.
“For years we’ve had to deal with the fact that it [takes] years and years for patients to get a good diagnosis of dementia,” he said on Thursday.
“Those are lost years in terms of your ability to find the support you need, get the information that you and your families really desire to understand what’s going on, and … to access the treatments.”
Mr Butler did not provide a timeline of when Australians would be able to access the new test via their GP, nor did he make any commitments to the federal government providing additional funding to support research relating to the new test.
“Obviously, I’d like to see it sooner rather than later, but we’ve got to have Australian data to be able to show a case for the clinical effectiveness to the exact advisory committee that really oversees the Medicare schedule,” he told media.
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“We’ve also got some challenges with listing of the treatments that are on the global market.
“There’s been a really significant effort into health and medical research in dementia for many years now. I remember making targeted calls for research 15 years ago when I first became a minister in this area.
“Since then there have been additions under the Medical Research Future Fund into this, and it covers not just discovery research at the bench top to understand the biology of what is driving this condition, but also health services research that that will help clinicians and hospitals and aged care settings and primary care, make sure they have got the best information to give their patients the best possible support.”
A NeuRA spokesperson said doctors could expect to be able to refer patients for the test, which has been approved for use in clinical trials, in the next six to nine months, according to the ABC.
Dementia is the country’s leading cause of death, with the Australian Bureau of Statistics recording over 17,500 dementia-related deaths in 2024.
