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5d ago

FDA Approves First Blood Test for Alzheimer’s Diagnosis in Symptomatic Patients

The Lumipulse test offers a less invasive diagnostic option for patients 55 and older, paving the way for earlier detection and expanded treatment access.

The new test may help reduce reliance on positron emission tomography or PET scans, a type of brain imaging that can be expensive.
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FILE - R. Scott Turner, Professor of Neurology and Director of the Memory Disorder Center at Georgetown University Hospital, points to PET scan results that are part of a study on Alzheimer's disease at Georgetown University Hospital in Washington, May 19, 2015. (AP Photo/Evan Vucci, File)
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Overview

  • The FDA has cleared Fujirebio Diagnostics' Lumipulse blood test, the first approved blood-based diagnostic for Alzheimer’s disease.
  • The test measures the ratio of two proteins, pTau217 and β-amyloid 1-42, to detect amyloid plaques associated with Alzheimer’s.
  • Authorized for patients aged 55 and older with cognitive decline, the test demonstrated over 97% accuracy for negative results and 91.7% for positive results in clinical studies.
  • Lumipulse provides a less invasive alternative to PET scans and spinal taps, potentially streamlining early diagnosis and access to amyloid-targeting therapies like Leqembi and Kisunla.
  • The test is expected to initially serve as a tool to rule out Alzheimer’s, with positive results requiring confirmatory testing before a final diagnosis.