Bron Alzheimer News Today:
by Marisa Wexler MS | May 16, 2022
The U.S. Food and Drug Administration (FDA) has granted marketing permission to a new test that checks for amyloid plaques in people being checked for Alzheimer’s disease.
The Lumipulse G ß [beta]-Amyloid Ratio (1-42/1-40) test, which will be sold by Fujirebio Diagnostics, is now approved for adults ages 55 and up who are being evaluated for Alzheimer’s and other causes of cognitive decline.
“FDA authorization of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) test and the upcoming U.S. launch are important milestones in the campaign to transform [Alzheimer’s] into a manageable disease,” Monte Wiltse, president and CEO at Fujirebio, said in a press release.
Fujirebio applied for FDA authorization late last year.
“Patients, physicians and families now have a valuable new tool to help identify those individuals whose early symptoms may be indicative of [Alzheimer’s], providing the opportunity to adopt life style changes and potentially to access new therapies aimed at slowing or stopping disease progression,” Wiltse said, adding that the authorization reflects the company’s “ongoing commitment to working with the healthcare community and [Alzheimer’s] advocates to achieve significant progress against this devastating disease.”