 "Alzheimer's blood test, brain health")
The US Food and Drug Administration (FDA) has approved the first-ever in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. Set to launch in June 2025, the test offers a faster, more accessible, and less invasive alternative to PET scans and spinal taps, especially for people showing early signs of memory loss and cognitive decline.
It has been granted “Breakthrough Device” designation by the FDA, reflecting its potential to significantly improve Alzheimer’s detection and care.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A Makary in a statement. “Knowing that 10 per cent of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
What is the Lumipulse blood test and how does it work?
Developed by Fujirebio Diagnostics, the test is called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. It measures the ratio of two key biomarkers in the blood—β-amyloid 1-42 and β-amyloid 1-40—both of which are linked to the buildup of amyloid plaques in the brain, a defining feature of Alzheimer’s disease.
Who can take Alzheimer's blood test and when should it be used?
The test is intended for adults aged 55 and older who are showing early signs of cognitive decline, such as memory loss or confusion. It is not a screening tool for asymptomatic individuals and is not available over the counter.
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The FDA emphasised that the test should support, not replace, a doctor’s clinical assessment. It requires a physician’s referral and is not meant for standalone diagnosis.
What are the current ways Alzheimer’s is diagnosed?
Traditional diagnostic methods include:
- Cognitive tests and memory assessments
- Brain scans such as MRI or PET
- Spinal taps for cerebrospinal fluid (CSF) analysis
These tests can be costly, invasive, and are not always covered by insurance—especially in developing countries.
How accurate is the Alzheimer's blood test compared to current diagnostic methods?
In a clinical trial involving 499 patients, the test demonstrated high diagnostic reliability:
- 91.7 per cent of people with positive results had Alzheimer’s-associated plaques confirmed by PET scans or spinal taps
- 97.3 per cent of those with negative results had no plaques
This level of accuracy could significantly reduce the need for expensive and invasive PET imaging or lumbar punctures.
When and where will the Alzheimer's test be available?
Fujirebio has confirmed that the test will be available in certified laboratories across the United States starting June 2025. It will not be sold directly to consumers and will require a physician’s order.
There is currently no confirmed timeline for the test’s launch in India or other international markets. However, experts believe regulatory approvals in other countries may follow based on US data.
How can this test impact Alzheimer’s treatment?
Early diagnosis allows earlier intervention, which is critical to slowing the progression of Alzheimer’s disease. This test could help doctors identify candidates for drugs like Leqembi (lecanemab) and Kisunla (donanemab) before significant brain damage occurs.
A positive test result indicates the presence of amyloid plaques but does not confirm Alzheimer’s on its own. False positives and negatives are possible, and results must be interpreted alongside other clinical evaluations.
Why this matters for Alzheirmer's patients and caregivers
This new blood test marks a significant breakthrough in making Alzheimer’s diagnosis more accessible and less burdensome. For families and patients, it could mean earlier answers, targeted treatments, and improved planning for the future. For more health updates, follow #HealthWithBS
This content is for informational purposes only and is not a substitute for professional medical advice.
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