FDA Clears First Blood Test for Alzheimer Disease: Daily Dose
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On May 17, 2025, we reported on the US FDA clearance for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer disease (AD).
The approval
The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio assay (Fujirebio Diagnostics, Inc) was cleared through the 510(k) pathway as a first blood test to aid AD diagnosis. The diagnostic is intended for adults aged 55 years and older who present with cognitive impairment and is designed to help clinicians determine the likelihood of cerebral β-amyloid plaque deposition.
The chemiluminescent immunoassay quantifies plasma concentrations of phosphorylated tau 217 (pTau217) and β-amyloid 1-42, then reports their ratio. Positive or negative results correlate with amyloid positron emission tomographic imaging or cerebrospinal fluid (CSF) biomarker profiles but avoid the radiation exposure of imaging and the invasiveness of lumbar puncture. The assay is labeled for use in specialized care settings as an adjunct to a comprehensive clinical work-up and is not authorized for population screening. The FDA cautioned that false-positive results may prompt unnecessary therapy and psychological distress, whereas false-negative results could delay appropriate treatment.
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