FDA Approves First-Ever Blood Test for Alzheimer's—Here's What We Know
As of 2023, an estimated 6.7 million Americans aged 65 and older were living with Alzheimer's disease, according to the Alzheimer's Association. With that number projected to more than double to 13.8 million by 2060, the FDA has just approved the first blood test designed to help diagnose the disease—marking a major step forward in early detection and treatment.
Manufactured by Fujirebio Diagnostics, the test will be used on individuals 55 and older who are currently exhibiting signs and symptoms of the disease.
Alzheimer's disease is a type of dementia that affects memory and thinking capabilities. It may start with mild memory lapses like forgetting where your keys are, and eventually can turn into severe memory issues like forgetting loved ones.
'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' FDA Commissioner Martin A. Makary, M.D., M.P.H., said in a press release. '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.'
While there are several methods for diagnosing Alzheimer's, one of the most common is through the detection of amyloid plaques—or abnormal protein deposits that form between nerve cells in the brain. Traditionally, plaques are identified using amyloid PET scans, which are both expensive and time-consuming. Another option is a cerebrospinal fluid (CSF) test, which involves collecting CSF via an invasive lumbar puncture, or spinal tap.The new blood test takes the need for PET scans or spinal taps out of the equation by measuring the ratio of two proteins—pTau217 and β-amyloid 1-42. The ratio can help clinicians determine whether amyloid plaques are present in the brain.
In a clinical study, 91.7% of people who received a positive blood test result also had amyloid plaques confirmed by a PET scan or CSF test. 97.3% of people who got a negative blood test result also had no amyloid plaques according to the PET or CSF test.
The results indicate that the test is a reliable way to detect and rule out amyloid plaques without the need for invasive strategies like brain scans or spinal taps.
'Nearly 7 million Americans are living with Alzheimer's disease, and this number is projected to rise to nearly 13 million,' said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. 'Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients who are earlier in the disease.'
According to the FDA, the main concern with the blood test is the possibility of a false positive, which "could lead to an inappropriate diagnosis of, and unnecessary treatment for Alzheimer's disease."
It's also important to note that this new blood test is not intended to be used as a stand-alone diagnostic test and should be utilized in conjunction with other clinical evaluations or additional testing.
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