FDA approves Lumipulse, the first blood test to detect Alzheimer’s, offering a less invasive option to diagnose the neurodegenerative disease.
In a groundbreaking medical advancement, the U.S. Food and Drug Administration has granted approval to Fujirebio Diagnostics’ Lumipulse, making it the first blood test officially cleared to detect Alzheimer’s disease.
This milestone signals a major shift in how Alzheimer’s may be diagnosed—moving away from complex and invasive procedures to a simple blood draw.
How Lumipulse Works
The Lumipulse test measures levels of two key proteins in the bloodstream:
- pTau217
- β-amyloid 1-42
It then calculates a ratio that helps determine the presence of amyloid beta plaques—a primary marker of Alzheimer’s disease. These plaques lead to the breakdown of neurons responsible for memory and cognition.
Traditionally, such biomarkers could only be detected through expensive PET brain scans or invasive spinal taps. With Lumipulse, a routine blood sample now provides a comparable early diagnostic indicator.
Why This Matters: A Game-Changer for Early Diagnosis
Alzheimer’s affects more people than breast and prostate cancer combined. Roughly 10% of people aged 65+ currently live with the condition—a number projected to double by 2050.
FDA Commissioner Dr. Martin Makary emphasized the importance of innovation:
“Knowing the scale of this disease, I am hopeful that new medical products such as this one will help patients.”
While Lumipulse is likely to be used initially to rule out Alzheimer’s, a positive result will guide patients toward more detailed neurological testing and care.
How It Compares: A Top Performer Among Peers
Lumipulse ranked as one of the top two Alzheimer’s blood tests in a Washington University study, alongside PrecivityAD2 from C2N Diagnostics. This adds further credibility to its diagnostic power.
Meanwhile, FDA-approved drugs like Leqembi (Biogen/Eisai) and Kisunla (Eli Lilly) aim to slow the disease’s progression—indicating a growing arsenal of tools in the fight against Alzheimer’s.
Stay tuned to Maple News Wire as we continue tracking the latest in medical innovations and public health breakthroughs.
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