FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
On May 16, 2025, the U.S. Food and Drug Administration (FDA) today cleared for marketing the first invitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “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.”
You can read the full FDA press release here.