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May 17, 2025 – In a groundbreaking advancement for Alzheimer’s disease (AD) diagnosis, the U.S. Food and Drug Administration (FDA) has granted clearance to the first blood test designed to aid in identifying the disease. The test, known as the Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio, is manufactured by Fujirebio Diagnostics, Inc. and is intended for adults aged 55 and older who exhibit signs and symptoms of cognitive decline.
A Simpler Path to Early Detection
Alzheimer’s disease, a condition affecting more Americans than breast and prostate cancer combined, has long posed challenges for early and accurate diagnosis. Traditionally, detecting amyloid plaques in the brain-a hallmark of AD-requires invasive procedures such as PET scans or cerebrospinal fluid (CSF) analysis. The newly approved Lumipulse blood test offers a less invasive alternative, requiring only a simple blood draw.
“This new test has the potential to make Alzheimer’s diagnosis easier and more accessible for patients, especially in the early stages,” said FDA Commissioner Martin A. Makary, MD, MPH. “With the number of Americans living with Alzheimer’s expected to nearly double by 2050, innovations like this are crucial.”
How the Test Works
The Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio measures the levels of two proteins-pTau217 and Beta-amyloid 1-42-in the blood. The ratio of these proteins is closely linked to the presence or absence of amyloid plaques in the brain. In a multicenter clinical study involving 499 adults with cognitive impairment, the test demonstrated high accuracy:
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91.7% of individuals with a positive blood test result also had amyloid plaques confirmed by PET scan or CSF analysis.
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97.3% of individuals with a negative blood test result were confirmed negative for amyloid plaques by other methods.
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Fewer than 1 in 5 patients received an indeterminate result.
“These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired,” the FDA stated.
Not a Stand-Alone Diagnostic Tool
While the Lumipulse test marks a significant step forward, it is not intended as a screening tool or as a stand-alone diagnostic test. Its results should be interpreted alongside other clinical information, and further evaluations or tests may be necessary to determine treatment options.
The test is intended for use in specialized care settings for patients already showing signs of cognitive decline.
Looking Ahead
Nearly 7 million Americans are currently living with Alzheimer’s disease, a number projected to rise to nearly 13 million in the coming decades. Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, called the approval “an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease.”
The Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio has also been granted breakthrough device designation, underscoring its potential impact on patient care.
Disclaimer:
This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. The Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio blood test is intended for use in specialized clinical settings and should not be used as a stand-alone diagnostic tool. Patients should consult their healthcare providers for personalized medical guidance. For more details, refer to the official FDA announcement and consult with a qualified medical professional.
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