Overview
- Parent company HU Group said on November 25 that Fuji Rebio filed for manufacturing and marketing approval with Japan’s health ministry, leaving the assay pending regulatory review.
- The proposed blood test estimates brain amyloid accumulation by measuring plasma amyloid‑beta and tau concentrations and their ratio.
- The company presents the approach as enabling earlier care through a simple blood draw that reduces patient burden relative to current confirmatory methods.
- Existing options in Japan include amyloid PET scans and cerebrospinal fluid tests, which are costly and invasive, with PET copays reported at roughly ¥40,000–¥70,000.
- Comparable blood-based diagnostics received authorization in the United States in May and in India in June, offering international context for Japan’s evaluation.