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    PAPER FDA-LUReview2025

    FDA clearance of the Lumipulse G pTau217/beta-amyloid 1-42 plasma ratio — first blood test to aid Alzheimer's disease diagnosis (2025)

    In May 2025 the U.S. FDA cleared the Lumipulse G pTau217/beta-amyloid 1-42 plasma ratio as the first blood test to aid Alzheimer's disease diagnosis in symptomatic adults aged 55 and older.

    Evidence

    6/10

    Moderate Evidence

    Sample

    —

    subjects

    Duration

    —

    study period

    Journal

    —

    May 2025

    02

    Key Findings

    1. 01

      First FDA-cleared blood test to aid AD diagnosis (May 2025)

    2. 02

      Indicated for symptomatic adults aged 55+ as an aid, not a stand-alone diagnosis

    03

    Structured Methods

    Study Design
    Review
    Sample Size
    Not reported
    Study Duration
    Not reported
    Methodology
    Not reported
    Limitations
    Not reported
    04

    Citations & References

    Cite this paper

    Unknown authors (2025). FDA clearance of the Lumipulse G pTau217/beta-amyloid 1-42 plasma ratio — first blood test to aid Alzheimer's disease diagnosis (2025).

    Source

    Publisher

    05

    Indexing

    Topics

    Alzheimer'sFDA clearanceblood biomarker

    Biomarkers

    p-Tau 217
    PHS
    671
    / 1000
    T3
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