FDA clears first blood test to aid Alzheimer's disease diagnosis

The Lumipulse plasma test provides clinicians with a less invasive way to assess amyloid pathology in cognitively impaired adults aged 55 years and older, potentially reducing reliance on PET imaging and cerebrospinal fluid testing.

The US Food and Drug Administration (FDA) has cleared Fujirebio's Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio for the early detection of amyloid plaques associated with Alzheimer's disease in adults aged 55 years and older who show signs and symptoms of cognitive decline, making it the first blood-based in vitro diagnostic cleared by the FDA to aid Alzheimer's diagnosis. The test measures plasma pTau217 and β-amyloid 1-42 and could provide a more accessible assessment of amyloid pathology than PET imaging or cerebrospinal fluid testing, although it is not intended for screening or use as a standalone diagnostic.

Field	Content
Alert Type	Drug Approval
Drug Name	Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio
Indication	Blood-based in vitro diagnostic for the early detection of amyloid plaques associated with Alzheimer's disease in adults aged 55 years and older who exhibit signs and symptoms of the disease. Results must be interpreted alongside other clinical information and the test is not intended as a screening or standalone diagnostic. (U.S. Food and Drug Administration)
Therapy Area(s)	Neurology; Alzheimer's disease; Diagnostics
Geography	United States (FDA)
What Happened	On 16 May 2025, the FDA granted 510(k) clearance to Fujirebio Diagnostics' Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, making it the first blood test cleared to aid in diagnosing Alzheimer's disease. The assay measures plasma pTau217 and β-amyloid 1-42 and calculates their ratio to assess the likelihood of amyloid plaque pathology. The FDA determined the test was substantially equivalent to Fujirebio's previously authorised cerebrospinal-fluid-based Lumipulse G β-amyloid Ratio test. (U.S. Food and Drug Administration)
Why It Matters	Assessing Alzheimer's-related amyloid pathology has traditionally relied on tools including PET imaging and cerebrospinal fluid testing, which can be costly, time-consuming or invasive. A blood-based test provides clinicians with a less invasive option that could make amyloid assessment more accessible for symptomatic patients, while still requiring interpretation alongside the wider clinical evaluation. (U.S. Food and Drug Administration)
Supporting Context	In a multicentre study of 499 cognitively impaired adults, 91.7% of people with positive Lumipulse results were confirmed as amyloid-positive by PET or cerebrospinal fluid testing, while 97.3% of those with negative results were amyloid-negative by these reference methods. Fewer than 20% received an indeterminate result. (U.S. Food and Drug Administration)
Key Takeaway	FDA clearance establishes the Lumipulse assay as the first blood-based test authorised in the US to aid Alzheimer's diagnosis, providing a less invasive route to assessing amyloid pathology in symptomatic adults aged 55 years and older. (U.S. Food and Drug Administration)
Primary Source	FDA clearance announcement
Relevant Date	16 May 2025

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