Alzheimer’s Blood Test: FDA Approves First Diagnostic Method

The US Food and Drug Administration (FDA) first approved the technology to diagnose Alzheimer’s disease with blood tests.

Alzheimer’s blood test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in plasma to determine whether the Alzheimer’s disease occurs. This ratio is associated with amyloid beta and tau protein in the brain.

Alzheimer’s disease, the most common cause of dementia, is characterized by a protein called amyloid beta to form plaque and tau protein tangles.

In order to diagnose Alzheimer’s disease, it has been relying only on very expensive and invasive tests, such as the lumps, magnetic resonance imaging (MRI), and the positive electron emission layer (PET).

The approved blood test is only possible with blood collection, which is very accessible.

According to multiple local media, the FDA has approved the Lumi Pulse test only for patients over 55 years old with Alzheimer’s disease. For patients with professional medical institutions with cognitive decline, the test results must be interpreted comprehensively with other clinical information of the patient.

“Alzheimer’s disease affects more people than combined with breast cancer and prostate cancer,” said Marty Macari, director of FDA. There are two types of Alzheimer’s disease treatments: Lecanemab and Donanemab. Lecanemab and Donanemab have shown that they slightly slow down cognitive function by targeting amyloid plaque, but they cannot completely treat Alzheimer’s disease.

If you start treatment early in the onset, it is known to have a better effect, so fast diagnosis is important.

As a result of clinical trials, blood tests showed almost the same accuracy as lumbar electronics, MRI, and PET analysis results.

The developer has not yet disclosed the inspection cost.