FDA Clears First Blood Test To Help Diagnose Alzheimer's Disease 8
An anonymous reader quotes a report from the Associated Press: U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer's and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease. The test can aid doctors in determining whether a patient's memory problems are due to Alzheimer's or a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing early signs of the disease.
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions. [...]
A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren't reviewed by the FDA and generally aren't covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a "wild west." Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics. The tests can only be ordered by a doctor and aren't intended for people who don't yet have any symptoms.
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions. [...]
A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren't reviewed by the FDA and generally aren't covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a "wild west." Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics. The tests can only be ordered by a doctor and aren't intended for people who don't yet have any symptoms.
FDA Cleared != FDA Approved (Score:2)
As John Oliver reminded us awhile back [pastemagazine.com], "FDA Cleared" is not the same as "FDA Approved."
Still, it's something.
Re: (Score:2)
The question is, how long before Kennedy guts the FDA, making it incapable of either approving or clearing medications of any kind.
I note that scientists are already considering moving from the US [spiegel.de] and that academics are being invited to France [lemonde.fr] amongst other European countries.
Re: (Score:2)
The question is, how long before Kennedy guts the FDA, making it incapable of either approving or clearing medications of any kind.
Time will tell if that shouldn’t have been done long ago, but FDA and American food safety are not exactly aligned. Which is putting it fucking mildly.
How long before we find out the FDA was part of the problem.
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How long before we find out the FDA was part of the problem.
Well I don't know, I would need some evidence to decide. Do you actually have any?
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Well, it is part of the problem now. The Dimwit in charge now wants ALL vaccines to be tested with placebos. Sounds reasonable, eh? Brand spanking new vaccines are tested with placebos, if there are no ethical questions for doing so (i.e., polio).
However, for vaccines already fielded and whose virus target is susceptible to change every year, those vaccines are not tested against a placebo because by the time the placebo testing was completed, the year has come and gone and the new vaccine is much less effe
Can we make the test mandatory ... (Score:3)
Re: (Score:2)
Can we make the test mandatory for politicians?
Start with the voters. They’re the ones electing Ancient History to serve. Again and again and again.
Correlation != cause (Score:2)
Before we go jumping for joy, the jury is still out on the plaque as the cause of Alzheimerâ(TM)s and not just a correlation or end product of the degradation process
20+ years of drugs targeting plaque have shown poor results