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U.S. Food and Drug Administration advisory panel said Thursday that it has recommended a new brain scan procedure that can detect Alzheimer’s disease, as long as doctors receive additional training to use it.
The FDA expert panel said that they have voted 16 to 0 to recommend approval of the imaging agent, known as Amyvid, made by US pharmaceutical giant Eli Lilly. The panel also revealed that the process involves injecting the Amyvid followed by an imaging scan that can detect plaque, or beta-amyloid aggregates, that indicate the presence of Alzheimer’s.
FDA suggested that a training program would be implemented to prove its usefulness and reliability in a real-world setting before it’s ready for clinical use.
“The FDA wants the company to first take a look at the data and make sure there is reliability in the data analysis. And second, to implement a training program for radiologists and technicians on how they are going to interpret the scan results in order to give a positive or a negative result,” said Alzheimer’s Association’s Maria Carrillo, who attended the FDA meeting and gave public testimony during the hearing.
Alzheimer’ disease, which has no cure, affects around five million Americans and 26 million people worldwide.