FDA approves blood test to diagnose Alzheimer’s disease: first of its kind

The first blood test used to diagnose Alzheimer’s disease was cleared by the Food and Drug Administration for marketing on Friday, meaning the lab test can be marketed and sold in the United States (US), an important benchmark for detecting the brain disorder that affects 10% of people aged 65 and older.

The diagnostic device that tests blood to help diagnose Alzheimer’s was developed by Fujirebio, a Japanese biotechnology company.

Unlike the recently approved blood testing device, other FDA-cleared or approved Alzheimer’s tests used cerebrospinal fluid samples from patients collected through lumbar punctures (invasive procedures involving lumbar puncture).

Michelle Tarver, a senior FDA official, said the clearance makes Alzheimer’s diagnosis “easier and potentially more accessible for U.S. patients in the early stages of the disease.” An FDA study found that the blood test “can reliably predict” the presence of protein conditions associated with Alzheimer’s at the time of testing in patients with cognitive impairment.

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