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4mo ago

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.

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