


FDA Approves First Blood Test for Alzheimer’s Diagnosis
The FDA has approved a blood test to help diagnose Alzheimer’s in patients over 55, marking a milestone in cognitive health.
Overview
The FDA has endorsed the Lumipulse blood test from Fujirebio Diagnostics, Inc. for diagnosing Alzheimer’s disease in individuals over 55 with cognitive decline. This first-ever blood test identifies beta-amyloid plaques linked to Alzheimer’s, offering a less invasive and more cost-effective alternative to costly PET scans and spinal fluid tests. This approval supports early intervention with new treatments like Leqembi and Kisunla, which can modestly slow disease progression. Dr. Michelle Tarver from the FDA emphasized the test’s potential for improving patient access to timely diagnosis and appropriate treatment.
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Analysis
Left
There are not enough sources from this perspective to provide an analysis.
Center
The FDA has cleared the first blood test for Alzheimer’s disease, making early diagnosis more accessible and potentially beneficial for patient treatment.
Right
The blood test provides a less invasive and lower-cost alternative to existing Alzheimer’s diagnostic methods, which include spinal fluid tests and PET scans.
There are concerns about the accuracy of existing lab-developed tests that have not received FDA approval, making the regulatory clearance of the new test a significant step forward in ensuring reliable Alzheimer's diagnosis.
Left
There are not enough sources from this perspective to provide an analysis.
Center
The FDA has cleared the first blood test for Alzheimer’s disease, making early diagnosis more accessible and potentially beneficial for patient treatment.
Right
The blood test provides a less invasive and lower-cost alternative to existing Alzheimer’s diagnostic methods, which include spinal fluid tests and PET scans.
There are concerns about the accuracy of existing lab-developed tests that have not received FDA approval, making the regulatory clearance of the new test a significant step forward in ensuring reliable Alzheimer's diagnosis.
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