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FDA Clears First Blood Test for Diagnosing Alzheimer’s Disease: A New Era of Accessible, Early Detection for Dementia.
On 16 May 2025, the FDA cleared the first blood-based test for diagnosing Alzheimer’s disease—a major shift in how we detect the condition. Developed by Fujirebio Diagnostics, the Lumipulse test offers a simpler, faster, and less invasive alternative to PET scans and spinal taps, bringing early detection within easier reach for patients showing signs of cognitive decline.

Noel Ong
Jun 178 min read
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