CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
May 11, 2022—Fujirebio Diagnostics announced that the FDA has granted de novo marketing authorization for its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for assessing β-amyloid pathology in patients who are being evaluated for Alzheimer disease and other causes of cognitive decline.
The test measures the concentrations of β-amyloid 1-42 and β-amyloid 1-40 in cerebrospinal fluid to calculate a numerical ratio as a proxy for the presence of β-amyloid plaque in the brain. It is intended for use in adult patients aged 55 years and older, the company says, and is not intended as a screening or standalone assay to diagnose AD. Results must be interpreted in conjunction with other patient clinical information.
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