FDA Approves Fujirebio Diagnostics’ Lumipulse G ß-Amyloid Ratio Test for Alzheimer’s

The FDA has approved Fujirebio Diagnostics’ in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.

The Lumipulse test, which is the first of its kind to be approved by the agency, is intended for patients age 55 and up who have symptoms of cognitive impairment and are being evaluated for Alzheimer’s disease 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 families concerned with the possibility of an Alzheimer’s disease diagnosis,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

The test “can give doctors the same information regarding brain amyloid status without the radiation risk,” he said.