In 2022, the U.S. FDA granted “Breakthrough Device” approvals for several diagnostic tests for AD. “Breakthrough Device” designation is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The following tests were given FDA approvals in 2022:
The Lumipulse G β-Amyloid Ratio (1-42/1-40) Test:
In May 2022, the FDA granted Breakthrough Device approval for Fujirebio Diagnostics’ Lumipulse G B-Amyloid Ratio (1-42/1-40) test for the early detection of amyloid plaques associated with AD. The test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The Lumipulse test uses cerebral spinal fluid (CSF) to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 (specific proteins that can accumulate and form plaques). The test is not intended as a screening or stand-alone diagnostic assay. Instead, the test is used to help physicians determine whether a patient is likely to have amyloid plaques, and the results must be interpreted in conjunction with other patient clinical information.
