(Image Source: UCLA)

BY LIZ REED

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“An FDA committee unanimously approving tests of a new Alzheimer’s test. That disease was thought to be caused by plaque in the brain. For the first time a scan allows doctor to see the plaque, confirming that a patient has it even before the patient might show any outward signs of the disease.” (Fox News)

The FDA approved a new test used to diagnose Alzheimer’s on the condition that Avid, the test’s developers, work out major flaws by March. The test uses a radioactive dye and PET scans to identify the disease, which could only be detected through autopsy previously.

While neurologists are optimistic about the test, Fox News’s senior medical contributor Manny Alverez says researchers need to educate doctors en masse on how to correctly use the test before the FDA will give the “OK.”

“The challenge is going to be that radiologists have to come up with the criteria that everybody reads these PET scans equally and what we do sometimes when we see plaques early on and there are no signs of Alzheimer’s disease.”

CNN’s health blog, The Chart, also points out that the test becomes less and less accurate the older the patient is. False diagnosis of Alzheimer’s can mask other health issues in the brain and the patient may be prescribed unnecessary medications.

“While the test is considered safe, members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee...voiced concern that there would be too many ‘false-positive’ tests – in other words, too many patients told they have Alzheimer's when in fact they don't."

Avid first brought the radioactive dye called Florbetapir to the FDA in 2008 as a potential diagnostic tool for Alzheimer’s. The FDA rejected the dye back then, saying researchers needed to prove that plaque detected in scans of living patients with Alzheimer’s matched their autopsy results.

The New York Times spoke with Dr. Norman Foster, a professor at the University of Utah, who said further delays to approval of the test will dramatically impact patients.

“He told of three patients he had seen in the past two weeks who would have benefited from a scan. One is a 70-year-old man with memory problems and depression. He was given a diagnosis of depression, but only after he continued to get worse over two years did it become clear that he most likely had Alzheimer’s.... ‘I wish I had had the ability to do an amyloid PET scan to allow an earlier diagnosis,’ Dr. Foster said.”

While the FDA wants to see consistency and ensure proper training before the test is approved, Voice of America describes just how much this test could impact science, health care, and people forever.

“There’s a sense of urgency in the research because people all over the world are living longer and that means more people, more caregivers, more families and more health care money will be impacted by this disease, which already effects 20 million people worldwide.”

So, what do you think? Is the FDA being overly cautious, or is the test still too flawed to trust?

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