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New FDA-Approved Alzheimer’s Blood Test Coming to Mayo Clinic

  • The FDA approved the Lumipulse blood test to help diagnose Alzheimer's disease in people aged 55 and older in clinical settings.
  • The approval follows recent advances in Alzheimer's research focused on improving diagnosis speed and accuracy to enable earlier treatment.
  • Fujirebio will distribute the test to 37 US Alzheimer's clinics, including Mayo Clinic, which plans to run up to 5,000 tests monthly.
  • A Mayo Clinic study on 500+ patients showed the test has 95% sensitivity and 82% specificity, matching invasive cerebrospinal fluid tests in accuracy.
  • This test may accelerate diagnosis and treatment access, improving outcomes as disease-modifying therapies become available and prompting similar UK adoption efforts.
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ajmc.com broke the news in on Wednesday, June 4, 2025.
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