U.S. health officials have approved the first blood test to aid in diagnosing Alzheimer’s disease, marking a significant advancement in early detection and treatment of the most common form of dementia. The Food and Drug Administration cleared the test for individuals aged 55 and older showing early signs of memory loss.
Developed by Fujirebio Diagnostics, Inc., the test detects beta-amyloid, a brain plaque closely linked to Alzheimer’s. Until now, confirming the presence of this protein required invasive spinal taps or costly PET scans. The new blood-based method offers a faster, more accessible, and less expensive alternative.
The approval could boost use of recently introduced Alzheimer’s medications such as Leqembi and Kisunla, which have shown modest benefits in slowing the disease’s progression. These drugs target beta-amyloid, and doctors must confirm its presence before prescribing them.
The test, however, is not meant for general screening or use in patients without symptoms. It must be ordered by a physician as part of a broader clinical evaluation.
More than six million Americans live with Alzheimer’s, and the number continues to rise. While several specialty labs have developed their own amyloid blood tests in recent years, they lacked FDA oversight and insurance coverage, raising concerns about accuracy and consistency.
Source: AP