NEW YORK – Fujirebio said Wednesday that its subsidiary Fujirebio Diagnostics has filed its Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic test with the US Food and Drug Administration for potential regulatory approval.
The test, which received breakthrough device designation from the FDA, measures levels of p-tau 217 and β-Amyloid 1-42 in human plasma to identify patients with the amyloid brain pathology characteristic of Alzheimer's disease.
If approved, the test would be the first commercially available blood-based IVD in the US for assessing individuals' Alzheimer's status. Currently, cerebrospinal fluid-based testing and PET imaging are commonly used for detecting amyloid brain pathology. Blood-based testing offers a less invasive, less expensive, and more easily scalable alternative to these approaches.
The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s automated Lumipulse G1200 instrument system. Fujirebio also offers a CSF-based Alzheimer's test, its Lumipulse G β-Amyloid Ratio (1-42/1-40), which was authorized by the FDA in May 2022.
"The lack of effective and accessible diagnostics for AD contributes to its late diagnosis and inadequate treatment," Monte Wiltse, president and CEO of Fujirebio Diagnostics, said in a statement. "We designed our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test to help physicians and patients with signs and symptoms of cognitive decline obtain an AD diagnosis much earlier when interventions are more effective."