FDA Clears First Blood Test for Diagnosing Alzheimer’s Disease: A New Era of Accessible, Early Detection for Dementia.
- Noel Ong
- Jun 17
- 8 min read
On 16 May 2025, the Food and Drug Administration (FDA) cleared the first blood-based test for diagnosing Alzheimer’s disease—a major shift in how we detect the condition. Developed by Fujirebio Diagnostics, the Lumipulse test offers a simpler, faster, and less invasive alternative to PET scans and spinal taps, bringing early detection within easier reach for patients showing signs of cognitive decline.
What the Test Does: From Complexity to Convenience
The Lumipulse test measures two key proteins in the blood—pTau217 and β-amyloid1-42, which are linked to the formation of amyloid plaques, one of the hallmarks of Alzheimer’s pathology. The test calculates a ratio of these proteins to predict the presence or absence of amyloid plaques in the brain, offering a reliable alternative to PET imaging or cerebrospinal fluid (CSF) analysis obtained through lumbar puncture.
Unlike previous tools, which required hospital-based imaging or spinal fluid extraction, this test only needs a simple blood draw, vastly improving patient accessibility and clinical efficiency. In clinical studies involving 499 cognitively impaired individuals, the test demonstrated a 91.7% positive predictive agreement and a 97.3% negative predictive agreement compared to PET or CSF results.
A Game-Changer in Early Alzheimer’s Detection
Alzheimer’s currently affects nearly 7 million Americans, and that number is expected to almost double by 2050. As emphasized by FDA Commissioner Dr. Martin A. Makary, this test could play a crucial role in earlier diagnosis, which is essential given the arrival of new Alzheimer’s therapies that are most effective in the early stages.
Dr. Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health, noted that this test is a critical step in broadening diagnostic reach, especially for underserved populations who may lack access to expensive neuroimaging technology.
Expert Insights: What Clinicians Are Saying
In a CBS News interview featuring Dr. Celine Gounder, the test was hailed as a major medical advance. She explained that the Lumipulse G Plasma Ratio Test targets amyloid and tau proteins—two key biomarkers of Alzheimer’s—and could dramatically improve the timeline for diagnosis and entry into clinical care.
Dr. Celine Gounder stressed the shift away from waiting until post-mortem autopsies for a definitive Alzheimer’s diagnosis:
“This is a much easier test to perform than say the PET scans or the spinal tap..… It’s a massive step forward in detection.”
Similarly, neurologist Dr. Leah Croll, speaking on Good Morning America, underscored that this test is not a standalone diagnosis tool but a vital addition to the diagnostic toolkit. She pointed out that the test’s breakthrough device designation allowed the FDA to fast-track its approval, and that early access to diagnostics is more critical than ever due to recent advances in Alzheimer’s treatment.
“This is such a big deal... To finally have a simple blood test that's accurate, fast, easy, and relatively cheap is huge. What this is going to allow us to do is get people that diagnosis faster, at a time when we finally have effective treatments for Alzheimer’s.”— Dr. Leah Croll, Neurologist, on Good Morning America
Risks, Limitations, and Responsible Use—Alzheimer's and Dementia
While promising, the FDA emphasised the importance of interpreting test results within a clinical context. Risks include false positives, which might lead to unnecessary emotional distress or treatment, and false negatives, which could delay further investigation and appropriate care. Therefore, the test is intended for patients over 55 years who are already exhibiting symptoms of cognitive decline and is not approved as a screening tool for asymptomatic individuals.
Additionally, further research will be needed to establish comprehensive guidelines for deployment in general practice and to prevent misuse or overtesting, particularly given the psychological and financial implications of a false Alzheimer’s diagnosis.
What This Means for the Future
The FDA's clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio ushers in a paradigm shift in Alzheimer’s diagnostics. With just a vial of blood, clinicians can now gain critical insight into brain pathology, leading to earlier intervention, targeted treatment, and potential enrollment in clinical trials. For millions of patients and their families, this is more than just a new test—it’s a new hope.
“Soon we will have this great test that will get people to the right specialists, the right treatment, the right clinical trials—even faster.”— Dr. Leah Croll on Good Morning America
“This test may not be perfect, but it’s a vital step toward earlier detection without the need for spinal taps or expensive scans.”—Dr. Celine Gounder on CBS Mornings
A Quick Look at Alzheimer’s Disease
Alzheimer’s disease is a progressive neurodegenerative disorder and the most common cause of dementia, typically beginning with short-term memory loss before advancing to language difficulties, disorientation, and loss of independence. The disease unfolds in three stages: early (mild memory issues and planning difficulties), middle (loss of speech fluency, behavioural changes, and disorientation), and late stage (complete dependency, immobility, and eventual loss of basic functions), Figure 1.
Figure 1: Stages of atrophy in Alzheimer's (source: Wikipedia)
Although the exact cause is still unclear, Alzheimer’s is closely associated with the buildup of amyloid plaques and tau protein tangles in the brain. Risk factors include age, genetics (especially the APOE-e4 gene), head injury, and cardiovascular conditions. Early detection is key—not just for diagnosis, but for timely access to care and emerging treatments. That’s what makes this FDA-approved blood test such a compelling development.
What This Approval Really Means
With this groundbreaking approval, the FDA has paved the way for a more democratized approach to Alzheimer’s diagnosis—one rooted in scientific rigour but designed for real-world application. As the medical community now works towards safe and widespread adoption, the Lumipulse test stands as a beacon of progress in a field long in need of better answers.
Recent Developments in Treatment in Australia
In May 2025, the Therapeutic Goods Administration (TGA) approved Kisunla (donanemab), marking the first new treatment for early Alzheimer's disease in 25 years (news.com.au). This medication targets and removes amyloid plaques in the brain, potentially giving patients in the early stages of the disease an additional two years of improved cognitive function.
Kisunla is administered intravenously every four weeks and is currently priced at $4,700 per dose. Efforts are being made to include it in the Pharmaceutical Benefits Scheme to lower costs for patients.
Samso’s Concluding Comments
This FDA approval is more than just a milestone for diagnostics—it’s a reflection of how far we’ve come in shifting Alzheimer’s care from reactive to proactive. What once required costly PET scans or invasive lumbar punctures can now begin with a simple blood draw. For patients, clinicians, and families navigating the uncertainty of cognitive decline, that simplicity is profound. We’re seeing science align with practicality, and it’s opening the door to earlier interventions, better planning, and perhaps most importantly, hope.
In Australia, there is a report of over 42,000 people diagnosed with dementia in 2024. Unfortunately, the number is projected to increase to more than 812,500 by 2054, marking a 93% rise over 30 years (Dementia Australia). In addition, approximately 29,000 Australians under the age of 65 are living with younger-onset dementia in 2024.
This figure is expected to rise to almost 41,000 by 2054, representing a 41% increase.
Some statistics for each state are listed below (Dementia Australia):
New South Wales (NSW): Over 138,200 people
Victoria (VIC): More than 107,600 people
Queensland (QLD): Around 82,270 people
Western Australia (WA): Over 40,500 people
South Australia (SA): Approximately 34,170 people
Tasmania (TAS): More than 10,600 people
Australian Capital Territory (ACT): Almost 5,900 people
Northern Territory (NT): Around 1,700 people
According to Dementia Australia, dementia, including Alzheimer's disease, is the second leading cause of death in Australia, accounting for 9.1% of all deaths in 2023. It is also the leading cause of death for Australian women. The mortality rate for dementia has increased by 842.8% over the past 50 years, while deaths from ischemic heart disease have decreased by 87.9%.
From an innovation lens, this is a reminder of the value in persistence. Fujirebio didn’t just bring a product to market—they validated years of research and clinical trials with data that stands up to scrutiny. It’s not perfect, and it’s not meant to replace full clinical assessments, but it enhances the diagnostic pathway in a meaningful way. That’s the kind of progress that often goes unnoticed until it becomes standard practice—quiet, methodical, and deeply transformative.
As with all medical breakthroughs, the real impact will unfold in time. What we can say now is that this is a step forward—one that makes detection more accessible and adds another layer to our understanding of Alzheimer’s. For those of us who follow the intersection of science, health, and long-term societal trends, this is a development worth watching. It tells us that while the road ahead remains complex, we are, without a doubt, heading in the right direction.
References:
1. FDA News Release: FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease, May 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease
2. Pharmacy Times: FDA Grants Market Clearance to Diagnostic Blood Test for Alzheimer Disease, May 19, 2025. https://www.pharmacytimes.com/view/fda-grants-market-clearance-to-diagnostic-blood-test-for-alzheimer-disease
3. CBS Mornings: FDA approves first blood test to help screen for Alzheimer’s disease. https://youtu.be/UAOHzhrI9K0
4. Good Morning America: FDA endorses 1st blood test to help diagnose Alzheimer’s disease. https://youtu.be/ar5JfgHt1No
To support our independent nature of our work, please head over to our Support Page and give us a helping hand in any of the ways listed. This is a new initiate for the Samso Platform, and it was always the concept of Samso when we started this journey in 2018.
Disclaimer
The information or opinions provided herein do not constitute investment advice, an offer or solicitation to subscribe for, purchase or sell the investment product(s) mentioned herein. It does not take into consideration, nor have any regard to your specific investment objectives, financial situation, risk profile, tax position and particular, or unique needs and constraints.
Share to Grow: Your Bonus
Samso has just released an eBook: How to Add Value to your Share Portfolio
A lesson on geological models sought by mining companies that gives insight and an understanding of which portfolios are better - and potentially more lucrative – investments. Click here to download this eBook.
If you find this article informative and useful, please help me share the information. I try and write about topics that are interesting and have the potential to be of investment value. It is not easy to find stories that fit those parameters. If you or your organisation see the benefit of what Samso is trying to achieve and have a need to share your journey, please contact me at noel.ong@samso.com.au.
Samso is a trusted platform that equips dedicated investors with up-to-date industry knowledge and insights from top CEOs and thought leaders. By staying informed on business advancements and market trends, investors can enhance their financial decisions through a combination of expert guidance and their own research.
Comments