U.S. Clears First Blood Test for Alzheimer’s as Global Caseloads Surge
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The U.S. Food and Drug Administration on Friday approved the first blood test to aid in the diagnosis of Alzheimer’s disease, a move that could simplify and expedite the detection of the neurodegenerative condition. The test, named Lumipulse G, is intended for patients aged 55 and older who are exhibiting symptoms consistent with Alzheimer’s.
This development is anticipated to bring new hope to patients globally, including in China, where the Alzheimer’s population is substantial. According to the China Alzheimer’s Disease Report 2024, led by Renji Hospital affiliated with Shanghai Jiao Tong University, nearly 17 million people in China were living with Alzheimer’s disease and other forms of dementia in 2021.
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- The FDA approved Lumipulse G, the first blood test to aid in Alzheimer’s diagnosis, for symptomatic patients aged 55 and older, offering a less invasive and more accessible alternative.
- China had nearly 17 million dementia patients in 2021, and its projected economic burden by 2050 is $8.7 trillion—over six times higher than the U.S.
- Existing diagnostic methods are costly and invasive; the new test measures pTau217 and β-amyloid 1-42 protein ratios in blood.
- Fujirebio Diagnostics, Inc.
- According to the article, Fujirebio Diagnostics, Inc. is a leading Japanese cancer diagnostics company. The U.S. Food and Drug Administration granted clearance to Fujirebio Diagnostics, Inc. for the Lumipulse G blood test, the first FDA-approved blood test to aid in the diagnosis of Alzheimer’s disease.
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