Particle.news
Download on the App Store
11 ARTICLES
·
last mo.

FDA Approves 95% Sensitive Blood Test for Alzheimer’s

Its launch at major US memory clinics marks the first noninvasive diagnostic tool that could streamline access to early treatment.

Image
The new drug saw compelling results for those with Alzheimer's (Photo: Brian Snyder/Reuters)
Image

Overview

  • The FDA authorized marketing of Fujirebio’s Lumipulse G pTau217/Aβ1-42 test with distribution to 37 US memory clinics, including Mayo Clinic, by the end of June.
  • A Mayo Clinic study of over 500 patients demonstrated the test’s 95% sensitivity and 82% specificity in detecting amyloid and tau protein markers.
  • Researchers report the blood-based assay matches the accuracy of lumbar punctures and PET scans while offering a less invasive and lower-cost option.
  • Next steps include validating the test in individuals without cognitive symptoms and in more diverse populations to ensure wide applicability.
  • The UK’s Blood Biomarker Challenge aims to introduce comparable blood diagnostics into the NHS by 2029 to support a growing pipeline of dementia therapies.