Overview

• The FDA has cleared Fujirebio Diagnostics' Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test for use in adults aged 55 and older showing cognitive symptoms.
• The test identifies Alzheimer’s-related amyloid plaques by analyzing the ratio of two proteins, offering a less invasive alternative to PET scans and spinal taps.
• Clinical trials demonstrated high accuracy, with 91–92% positive agreement and 97% negative agreement compared to traditional diagnostic methods.
• This blood test allows primary care providers to begin the diagnostic process earlier, potentially reducing delays in specialist evaluations.
• While promising, the test is not a standalone diagnostic tool and must be used in conjunction with other clinical assessments and confirmatory testing.