Particle.news
Download on the App Store
6 ARTICLES
·
23h ago

FDA Approves First Blood Test for Alzheimer’s Diagnosis

The test, cleared for symptomatic adults aged 55 and older, offers a faster, less invasive, and more affordable alternative to PET scans and spinal taps, with initial availability set for late June.

Stock image.
Image
Image
Sophie Morris has a blood sample taken at the VIAVI clinic in London (Photo: Tom Pilston)

Overview

  • The FDA has approved the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test, the first blood test for diagnosing Alzheimer’s disease.
  • Designed for patients aged 55 and older showing signs of cognitive decline, the test measures beta-amyloid and p-tau217 protein ratios to detect amyloid plaques.
  • Clinical studies show the test is nearly 92% accurate in detecting Alzheimer’s and over 97% accurate in ruling it out, comparable to PET scans and spinal taps.
  • The test will initially roll out at around 50 U.S. research centers and hospitals in late June, with broader access expected through CLIA-certified laboratories.
  • By reducing costs and improving accessibility, the test could accelerate early diagnosis and treatment for millions of Americans living with Alzheimer’s.