First FDA Cleared Blood Test for Alzheimer’s Diagnosis Marks Turning Point in Early Detection

Alzheimer’s disease is a progressive form of dementia that affects memory, cognition, and behavior, eventually interfering with daily activities. Early and accurate diagnosis is essential to improving outcomes, but until now, confirmation has often required invasive procedures like lumbar punctures or costly imaging methods such as PET scans both of which are barriers for many patients. These limitations have contributed to underdiagnosis or delayed treatment for the nearly 7 million U.S. residents currently living with the disease, a number projected to nearly double by 2050. Now, a new, less invasive blood test offers a breakthrough in detection by measuring protein biomarkers associated with Alzheimer’s pathology, offering a simpler and more accessible diagnostic option.

Fujirebio’s (Tokyo, Japan) Lumipulse has been approved by the U.S. Food and Drug Administration as the first blood test to aid in the diagnosis of Alzheimer’s disease. The test works by measuring the ratio of two key proteins found in blood plasma—pTau217 and ß-Amyloid 1-42, both strongly linked to the development of Alzheimer’s. Unlike PET imaging or cerebrospinal fluid analysis, the blood-based approach requires only a routine blood sample, making it significantly more patient-friendly.

Image: The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is FDA-cleared for use in diagnosing Alzheimer’s (Photo courtesy of Fujirebio)

In clinical validation studies, the Lumipulse test demonstrated 91.7% accuracy in identifying individuals with amyloid plaques and 97.3% accuracy in confirming the absence of pathology in negative cases. Its performance surpasses many conventional cognitive assessments. While the test enhances early detection and opens opportunities for timely care, access to clinical trials, and long-term planning, it does have limitations. It is not designed to predict future dementia in asymptomatic individuals and focuses only on amyloid and tau biomarkers, omitting other contributors to Alzheimer’s, such as vascular disease or neuroinflammation.

"This blood test offers a simpler, less invasive, and more widely accessible way to support accurate detection of amyloid plaques and tau tangles, two of the main pathological markers of Alzheimer’s disease," said Michal Schnaider Beeri, director of the Herbert and Jacqueline Krieger Klein Alzheimer’s Research Center within the Rutgers Brain Health Institute.

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