The FDA has endorsed the Lumipulse blood test from Fujirebio Diagnostics, Inc. for diagnosing Alzheimer’s disease in individuals over 55 with cognitive decline. This first-ever blood test identifies beta-amyloid plaques linked to Alzheimer’s, offering a less invasive and more cost-effective alternative to costly PET scans and spinal fluid tests. This approval supports early intervention with new treatments like Leqembi and Kisunla, which can modestly slow disease progression. Dr. Michelle Tarver from the FDA emphasized the test’s potential for improving patient access to timely diagnosis and appropriate treatment.