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SRC-810072405dc817f5 · Source record

FDA Clears First Blood Test Used in Diagnosing Alzheimer's Disease

U.S. Food and Drug Administration · 4 connected claims

D07 · Commerce, Productization & MarketplacesD09 · Legal, Compliance, Trust & RegTechD14 · Cybersecurity, Identity, Privacy & Resilience

Canonical route

https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease

Claims connected to this source

  1. MWITA-HW-2026-001On 16 May 2025 the FDA cleared the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio as the first blood test to aid diagnosis of Alzheimer's disease in symptomatic adults aged 55 or older in specialized care.Evidence A
  2. MWITA-LD-2026-032FDA evaluated the Lumipulse plasma ratio in 499 cognitively impaired adults against amyloid PET or cerebrospinal-fluid results.Evidence A
  3. MWITA-LD-2026-033In FDA's reviewed study, 91.7% of positive results had amyloid pathology and 97.3% of negative results lacked it, while fewer than 20% of results were indeterminate.Evidence A
  4. MWITA-LD-2026-034FDA warns that false Lumipulse results can cause inappropriate diagnosis or treatment, distress, unnecessary testing or delayed effective treatment.Evidence A

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