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.
Content generated by AI—learn more or report issue.
Get both sides in 5 minutes with our daily newsletter.
Analysis
- The FDA has cleared the first blood test for Alzheimer’s disease, making early diagnosis more accessible and potentially beneficial for patient treatment.
Articles (4)
No highlight available for this article.
CBS News·1M·No highlight available for this article.
Associated Press·1M·No highlight available for this article.
Boston Herald·1M·No highlight available for this article.
FOX News·1M·FAQ
The blood test approved by the FDA is called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio.
The Lumipulse G blood test was developed by Fujirebio Diagnostics, Inc.
The test is intended for adults aged 55 and older who are showing signs of cognitive decline.
The test offers a less invasive alternative to PET scans and spinal fluid tests, providing a more accessible and potentially cost-effective option for diagnosing Alzheimer's.
History
- This story does not have any previous versions.