Overview

• The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test is the first FDA-cleared blood test for Alzheimer’s diagnosis, targeting adults with cognitive decline.
• It measures key protein biomarkers in blood plasma to detect amyloid plaques, a hallmark of Alzheimer’s, with 91.7% positive and 97.3% negative agreement in clinical studies.
• The test is intended for use in specialized clinical settings and not for general population screening or standalone diagnosis.
• This development could expand access to amyloid-targeting drugs like Leqembi and Kisunla by simplifying the diagnostic process.
• Fujirebio Diagnostics, the test’s developer, utilizes its widely available Lumipulse system, enabling faster and more scalable Alzheimer’s screening.