Alzheimer’s blood test now set to revolutionise care
MELBOURNE: Those with the earliest signs of Alzheimer’s disease will have the opportunity to delay the disease’s progression decades before symptoms emerge as groundbreaking blood and biomarker tests are made available at a new specialist centre for Alzheimer’s disease diagnosis.
Alzheimer’s disease can be detected via the blood and cerebrospinal fluid as many as 20 years before symptoms appear.
The first tests capable of detecting the biological changes that begin in the brain are set to become available to consumers in Australia.
The Asia-Pacific Centre of Excellence for Alzheimer’s Diagnosis will transform the diagnosis of Alzheimer’s disease, processing the blood tests for the whole of Australia and paving the way for those diagnosed to have emerging therapies to slow the progression of dementia.
Health Minister Mark Butler will launch the Sydney-based centre – a partnership between Neuroscience Research Australia and Roche Diagnostics Australia – on Thursday.
It will be the first place in Australia where patients can have cutting-edge, non-invasive tests processed within minutes to detect the presence of an abnormal form of a protein known as tau, a diagnostic marker of Alzheimer’s disease. These tests are:
• The blood test pTau217, which can rule in or out Alzheimer’s disease pathology.
• The blood test pTau181, which can rule out Alzheimer’s pathology in people experiencing cognitive symptoms.
• A blood test to determine whether the gene ApoE4 is present, which is the strongest known genetic marker that raises the risk of developing Alzheimer’s disease later in life.
The crucial pTau217 test was granted regulatory approval in Australia earlier this year. It is being used in clinical practice across the US, the UK, throughout Europe and in parts of Asia.
It is not yet funded by Medicare in Australia, and it will cost a few hundred dollars for patients to have blood tests processed at the new centre for excellence.
The centre’s leaders hope the evidence generated will support a strong case for Medicare funding for the tests.
The new blood tests go a long way towards solving the current “diagnosis gap”. In Australia, those with Alzheimer’s disease wait an average of three to five years to receive a diagnosis. Around the world, an estimated 75 per cent of those with Alzheimer’s disease are undiagnosed.
The new Alzheimer’s blood tests have not been able to be utilised as yet by consumers in Australia because it takes specialist assays and equipment to analyse the samples. The NeuRA-Roche centre will use Roche’s cobas e402 platform, an automated system that processes blood samples with high throughput and precision.
Other diagnostic tests – PET scans and spinal taps – exist for Alzheimer’s but they are expensive or invasive and difficult for many to access. Early diagnosis of Alzheimer’s disease is important as more and more therapies and early interventions become available that can slow the disease’s progression, according to Emma Devenney, a Neuroscience Research Australia neurologist who will oversee the centre of excellence.
Current disease-modifying therapies such as monoclonal antibody treatments are restricted to people in the early stage of Alzheimer’s because that is when they are most effective.
“There’s traditionally almost been a reluctance to diagnose people early because there was the sense of ‘oh, there’s nothing really that we can do anyway’ and there’s a lot of stigma attached to dementia,” Associate Professor Devenney said.
“Definitely now there’s a change in the field and people are beginning to understand the importance of early diagnosis.
“That’s because we now have some treatments that can, albeit modestly, impact the disease trajectory. But we’re going to see an explosion in these therapies over the next few years.
“We actually want to move to a place where we can hopefully eventually prevent the disease, but at least for now try and intervene in the earlier stages to help people plan and give people a more meaningful quality of life.”
Dementia is now the leading cause of death in Australia and affects more than 446,500 people. The number diagnosed is expected to exceed one million by 2065.
The Asia-Pacific region has 20 per cent of the world’s population but shoulders more than 50 per cent of the global dementia burden. The NeuRA-Roche centre for excellence will work to establish and drive a regional standard of care that prioritises brain health and early intervention across the Asia-Pacific.
The establishment of the centre also means that Australian neuroscience researchers will have access to Roche’s research-only portfolio of therapies and will be able to contribute to future diagnostics development and evaluation for clinical utility.