Overview
- Fujirebio said it will apply to Japan’s Ministry of Health, Labour and Welfare before the end of 2025 for approval of its blood-based Alzheimer’s diagnostic.
- If cleared, the product would become the first domestically approved blood test for Alzheimer’s-type pathology in Japan.
- The assay quantifies two plasma proteins and their ratio to estimate amyloid-beta accumulation associated with Alzheimer’s disease.
- Fujirebio Holdings said blood testing reduces patient burden and can be performed more easily than amyloid PET imaging or cerebrospinal-fluid sampling.
- The planned filing follows a U.S. decision in May 2025 that authorized a similar blood test as an adjunct diagnostic for adults 50 and older with cognitive symptoms.