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FDA Clears First Blood Test to Reliably Predict Alzheimer’s Disease

  • On Friday, federal health authorities approved the first blood test in the United States designed to aid in diagnosing Alzheimer's disease.
  • This clearance follows a need for less invasive, reliable detection methods since existing ones required spinal fluid or radioactive imaging.
  • The test by Lumipulse measures protein ratios linked to brain amyloid plaques in blood samples from patients 55 or older showing Alzheimer's symptoms.
  • Lumipulse's test showed over 91% success in prior trials and Dr. Michelle Tarver noted nearly 7 million Americans live with Alzheimer's, expected to reach nearly 13 million.
  • This FDA approval may improve diagnosis accessibility, aid treatment decisions, and support expanding use of drugs that modestly slow Alzheimer's progression.
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Statement from the Alzheimer's Drug Discovery Foundation (ADDF) on FDA Approval of the First Blood Test to Aid in Alzheimer's Diagnosis

NEW YORK, May 16, 2025 /PRNewswire/ -- Today, the FDA's approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, marking a pivotal moment in the fight against Alzheimer's disease. This is the first blood test authorized to aid in the diagnosis…

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optometrytimes.com broke the news in on Friday, May 16, 2025.
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