FDA permits marketing for new in vitro Alzheimer’s disease test

The FDA granted breakthrough device designation and permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Developed by Fujirebio Diagnostics, the Lumipulse G β-Amyloid Ratio test is intended for adults, aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.
“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and

The FDA granted breakthrough device designation and permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Developed by Fujirebio Diagnostics, the Lumipulse G β-Amyloid Ratio test is intended for adults, aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.
“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and