Recently, Fuji Biological said that its subsidiary Fuji Biological Diagnostics has submitted Lumipulse G pTau 217/β-amylin 1-42 plasma ratio in vitro diagnostic test to the U.S. Food and Drug Administration for potential regulatory approval.
The test has been awarded the title of breakthrough device by the FDA. It identifies patients with the pathological characteristics of Alzheimer’s disease by measuring the levels of p-tau 217 and β-amylin 1-42 in human plasma.
If approved, the test will be the first commercial blood IVD in the United States to assess the status of an individual’s Alzheimer’s disease.Currently, cerebrospinal fluid-based assays and PET imaging are usually used to detect amyloid brain pathology.Blood testing provides a less invasive, lower-cost, and easier-to-scale alternative method.
The Lumipulse pTau 217/β-amylin 1-42 plasma ratio test uses Fujirebio’s automated Lumipulse G1200 instrument system.Fujirebio also provides a csf-based Alzheimer’s disease test, and its Lumipulse G beta-amyloid ratio (1-42/1-40) was approved by the FDA in May 2022.
Monte Wiltse, president and CEO of Fujirebio diagnostics, said in a statement: “The lack of effective and available diagnostic methods for Alzheimer’s disease has led to late diagnosis and insufficient treatment.” “We designed the Lumipulse G pTau 217/β-amyloid 1-42 plasma ratio test to help doctors and patients with signs and symptoms of cognitive decline obtain AD diagnosis earlier when interventions are more effective.”
