However, because there is no cure for Alzheimer's disease yet, the test might be one that is not considered worth its cost, Gandy said.
Gandy noted that the "300-pound gorilla in the room" is whether Medicare/Medicaid will reimburse such a test, even if the FDA follows its expert panel's advice and approves Amyvid. (While the FDA doesn't have to follow a panel's advice, it usually does.) "Medicare may decide that the added value does not merit reimbursement without a meaningful intervention," he said.
Also, Grandy said he doesn't expect approval until there are methods in place to train doctors in how to read these scans.
Another expert, David Loewenstein, a professor of psychiatry and behavioral sciences and neurology at the University of Miami Miller School of Medicine, said that the approval of Amyvid "will allow physicians to come to an earlier diagnosis of Alzheimer's."
What is needed is consistency for evaluating scans using the agent, he said, so that physicians "can apply a single standard and there won't be gaps between hospitals because of different readers using different methods."
Loewenstein thinks use of this new diagnostic tool will help in several ways. First, it will help researchers find effective treatments by diagnosing the disease early, although having the plaques does not always mean the patient has Alzheimer's. Second, it will identify people who can take part in clinical trials of new Alzheimer's drugs.
"There is a whole new line of drugs being formulated that will help treat the earliest stages of the disease," Loewenstein said. "We need to know who are the appropriate people with the mildest cognitive problems to get into clinical trials."
In addition, the test has value even before treatments are available in terms of helping patients p
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