Fujirebio files for FDA premarket clearance for Alzheimer’s test

Dec. 3, 2020

Fujirebio Diagnostics, a consolidated subsidiary of H.U. Group Holdings, announced that it has filed its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test with the U.S. Food and Drug Administration (FDA) for 510(k) premarket clearance, according to a company press release. 

The test was granted Breakthrough Device Designation by the FDA in February 2019 and is expected to be among the first commercially available in vitro diagnostic tests in the United States to help in the assessment of Alzheimer’s disease. The test is analyzed using Fujirebio’s fully automated Lumipulse G1200 instrument system.

Alzheimer’s disease is characterized by amyloid plaques in the brain, which afflicts more than 5 million Americans and is a leading cause of disability and death. Current tools available to evaluate amyloid pathology, such as amyloid PET imaging can be expensive, time consuming, and difficult to access. As a result, many patients are not diagnosed until their disease is well advanced, with few available treatment options.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the concentrations of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 found in human cerebral spinal fluid (CSF) into a numerical ratio of β-Amyloid1-42/β-Amyloid1-40. The ratio is a semi-quantitative in vitro diagnostic test intended to be used in adult patients, aged 50 years and over, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

The Lumipulse G β-Amyloid and Tau tests are already CE-marked for use in the European Union.

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