Press release summary
TOKYO — Fujirebio Inc. received Japanese manufacturing and marketing approval for a blood-based in vitro diagnostic assay that measures phosphorylated tau 217, or pTau217, in plasma, H.U. Group Holdings said Nov. 11. The assay runs on Fujirebio’s fully automated Lumipulse G1200 and G600II immunoassay systems and is intended to help clinicians assess amyloid-beta accumulation in the brain.
Amyloid pathology is associated with Alzheimer’s disease and is a target of recently introduced antibody therapies. Fujirebio said it filed for the Japanese authorization in November 2025. The company already offers a related pTau217/beta-amyloid 1-42 plasma ratio test that was cleared by the U.S. Food and Drug Administration in 2025. The newly approved Japanese assay measures pTau217 concentration rather than the two-marker ratio described in the U.S. product.
For laboratory readers, the approval matters because it extends a blood-based biomarker into an automated clinical testing workflow in Japan. Blood sampling may reduce reliance on more invasive cerebrospinal-fluid collection and increase testing capacity, but results remain an aid to clinical assessment rather than a stand-alone diagnosis.
Original source: H.U. Group Holdings and Fujirebio news release, Nov. 11, 2026.
Featured image: Lumipulse G1200 automated immunoassay analyzer, courtesy of Fujirebio.
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