Fujirebio announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA).
The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S. to help in the assessment of Alzheimer’s disease (AD). The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, which received Breakthrough Device Designation from the FDA, is an IVD test using measurable pTau 217 and β-Amyloid 1-42 concentrations found in human plasma. The test combines these concentrations into a numerical ratio of pTau 217/β-Amyloid 1-42 to identify patients with amyloid pathology associated with AD. β-Amyloid neuritic plaque pathology in the brain is believed to contribute to the loss of cognitive function that characterizes AD.
The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s fully automated Lumipulse G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022.
