Fujirebio Diagnostics obtained FDA clearance for the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio Test, the first blood-based FDA-approved in vitro diagnostic for Alzheimer’s disease. This test measures biomarker ratios in plasma to detect amyloid pathology with accuracy comparable to PET imaging or cerebrospinal fluid analysis. The minimally invasive, cost-effective assay enables earlier diagnosis, facilitating timely intervention and expanded research into Alzheimer's therapies.