Despite the hopes of many, a new test to identify and/or rule out Alzheimer”s is not quite ready for FDA approval.
has developed a PET scan that can detect or rule out the presence of Alzheimer’s disease in an individual patient. Despite its promising results, an FDA advisory panel has said that the test needs to undergo more screening to obtain approval.
The test is designed to detect the build up of amyloid plaque in an individual’s brain. The presence and build-up of which signifies the onset of Alzheimer’s disease. The PET scan can see this through the use of a special radioactive marker known as Florbetapir F18, which is being marketed under the brand name Amwid.
After the PET scan is conducted, if the test is positive, the doctor can begin treatment for Alzheimer”s disease; a negative result can guide the medical specialist to take an alternative course of treatment.
While the FDA considers the test to be safe, the FDA advisory panel wants the manufacturer to provide more training for the medical professionals who will be using the procedure. Another concern is the possibility of a false positive result for Alzheimer’s, an erroneous diagnosis that could lead many patients to be treated for Alzheimer”s even if they do not have the disease at all.
The advisory panel voted 16 to 3 for the approval of the test and procedure. Another follow up vote was cast with a result of 16 to 0 with three abstentions. The panel advised Avid that the test should be approved provided that Avid can ensure proper training and labeling on its packaging so that the test results will be analyzed and interpreted consistently and accurately.
As reported to CNN, the Alzheimer’s Association Senior Director for Medical and Scientific Relations, Maria Carillo, said that she expects that training concerns will be addressed enabling the drug to be approved later this year.
We will keep you updated.
