May 19, 2025—Fujirebio announced that the FDA has granted 510(k) clearance for its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test. It is the first FDA-cleared blood-based in vitro diagnostic test in the U.S. to aid in identifying patients with amyloid pathology associated with Alzheimer’s disease.
The test measures pTau 217 and β-amyloid 1-42 concentrations in plasma as a proxy for the presence of β-amyloid plaque pathology in the brain and is intended for use in adult patients aged 50 years and older presenting with signs and symptoms of cognitive decline pathology. It runs on the company’s fully automated Lumipulse G1200 instrument. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in cerebrospinal fluid in May 2022.