SYDNEY — A new era in dementia care has arrived in Australia following the Therapeutic Goods Administration’s (TGA) regulatory approval of blood tests designed to detect biological signs of Alzheimer’s disease.
The milestone coincides with the official launch of the Asia-Pacific Centre of Excellence for Alzheimer’s Disease Diagnosis at Neuroscience Research Australia (NeuRA) in Sydney, paving the way for faster, less invasive testing for the country’s most common form of dementia.
How the Tests Work
Until recently, confirming Alzheimer’s required expensive PET brain imaging or invasive lumbar punctures to analyze cerebrospinal fluid. The newly approved blood tests evaluate protein biomarkers in a standard blood draw to measure the same underlying brain changes.
Key biomarker options include:
- pTau217: Detecting phosphorylated tau 217, this test offers the highest diagnostic accuracy, performing closely alongside complex PET imaging.
- pTau181: A secondary marker effective primarily for ruling out Alzheimer’s pathology.
- APOE $\varepsilon$4: A genetic test that identifies an inherited risk factor, though it does not indicate whether a person will actively develop the disease.
Medical experts emphasize that blood biomarkers do not offer a standalone diagnosis. Instead, clinicians must evaluate blood test results alongside clinical assessments, cognitive tests, and medical histories to rule out other potential causes of cognitive decline, such as thyroid issues, vitamin deficiencies, or sleep disorders.
Targeted Use and Medicare Outlook
The TGA-approved tests are intended specifically for individuals exhibiting persistent cognitive symptoms or mild cognitive impairment—not as routine screening for healthy adults.
“These blood-based biomarkers can deliver earlier and quicker diagnoses, providing certainty that offers many benefits for patients,” said Associate Professor Emma Devenney, a neurologist at NeuRA.
Because the blood tests are not yet subsidized by Medicare, patients currently face out-of-pocket fees. However, health officials hope research gathered at the new NeuRA Centre of Excellence will build the necessary clinical evidence to support future Medicare funding and establish standardized national clinical guidelines.
