Breakthrough in Alzheimer's Detection
The has endorsed the first blood test by Fujirebio Diagnostics, Inc., for diagnosing Alzheimer's in patients 55 and older, marking a significant advancement in the early identification of the disease.
This test identifies beta-amyloid plaques, a key Alzheimer's marker, offering a less invasive and more accessible alternative to previous methods like spinal fluid tests and PET scans.
Implications for Treatment and Future Developments
The blood test's approval could enhance the utilization of Alzheimer's drugs Leqembi and Kisunla, which slow disease progression by clearing amyloid from the brain, by making diagnosis easier and potentially more affordable.
Despite the promising development, the market has seen unregulated in-house tests for amyloid, with several companies, including and , seeking FDA approval for their versions, indicating a competitive and evolving diagnostic landscape.