Posted on 05/16/2025 1:52:40 PM PDT by nickcarraway
Plasma assessment is not intended as a screening or stand-alone diagnostic test, agency says
The FDA cleared the first blood-based in vitro diagnostic test for Alzheimer's disease, the agency announcedopens in a new tab or window Friday.
The blood test, known as the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, can be used to detect amyloid plaques associated with Alzheimer's in people ages 55 and older who have signs and symptoms of the disease, the agency said.
"Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," FDA Commissioner Martin Makary, MD, MPH, said in a statement. "Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients."
The test measures phosphorylated tau 217 (p-tau 217) and beta-amyloid 1-42 concentrations in plasma to help detect amyloid plaques associated with Alzheimer's disease. It combines these concentrations into a numerical ratio of p-tau 217/beta-amyloid 1-42 to identify patients with amyloid pathology, reducing the need for a PET scan or cerebrospinal fluid (CSF) analysis.
The FDA's decision was based on a clinical study of 499 individual plasma samples from adults who were cognitively impaired. The test results were validated against amyloid PET or CSF tests and showed a 91.7% positive predictive value and 97.3% negative predictive value. Less than 20% of the 499 patients tested received an indeterminate result.
These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer's disease at the time of the test in patients who are cognitively impaired, the FDA said.
The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline, the agency emphasized. Results must be interpreted in conjunction with other patient clinical information.
Risks associated with the blood test are the possibilities of false positive and false negative test results, which could lead to inappropriate diagnosis, unnecessary or delayed treatment, and psychological distress.
"Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options," the FDA said.
More than 7 million older adultsopens in a new tab or window in the U.S. have Alzheimer's disease, according to the most recent Alzheimer's Association figures, and the number is expected to grow.
In 2022, the FDA issued clearance for the Lumipulse G β‐Amyloid Ratio -- the first in vitro diagnostic to measure amyloid in CSFopens in a new tab or window -- to Fujirebio Diagnostics in Japan, the same company that makes the newly cleared blood test.
Did they try it on Biden yet?
Wow. That’s great news.
They cannot stop it. Yet. But early intervention gives the patient and their family some extra time to get ready for that very long road.
Maybe. The problem is there is a faction in this country that will turn that early detection into early assisted suicide. I am not saying the test is a bad idea. Far from it, but we now live in a society where even good ideas get misused.
Wait. If Alzheimer’s is rising shouldn’t someone look for the cause? I grew up in the 50s and I can’t recall more than one or two older relatives that had Alzheimer’s or dementia. Most of my friends, same thing. Very rare iirc. It must be caused by something. Micro plastics? Aluminum? MSG? Something is causing this to increase by leaps and bounds.
Indeed. something is causing alzheimers at such a high incidence
possibly some of the chemicals in a certain well-known fast-food burger place’s grub? they’re (in-)famous for keeping an entire chemical additive industry alive in New Jersey
smiles smiles
or yes, aluminum tins (they were highly suspect shortly after their introduction), or some other chemical (probably in the food chain like, as you note, maybe MSG or?>?>), or just possibly an environmental factor or?
dementia of any label did exist 30 or 40 years ago but it seemed to be far, far rarer than nowadays
as you say, there has to be a cause...
Statins.
Probably a main reason is that obesity is a major risk factor for several chronic diseases (heart disease, diabetes, and some cancers and Alzheimer’s disease and dementia...).
Probably something in the universal time bomb vaccines that all Americans are subjected to in childhood ? Thimersol = mercury = dental fillings ??? Maybe we can’t outlive our shortening telomeres ??? Wish we knew and there was some breakthrough in treatment as there was with AIDS ?
Possibly our adulterated meat products?
That’s true, but life expectancies weren’t what they are now, so it’s possible more people are living long enough to develop it, where in the past they would have died before that point.
Also, when I think of my grandparents and other “old” people in the 1970’s, I don’t think any of them had their teeth. Makes me wonder if that has something to do with it.
Good points. Still I suspect there is something in the food chain, or environmental toxin at work. There is a massive increase of these conditions.
My personal feeling is that the rise in statin medicines for cholesterol must have a corresponding relation to the rise in Alzheimer’s. My sister who just passed after 10+ years with Alzheimer’s had been on a statin drug for years.
He’s got problems this drug is won’t cure.
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