US approves first blood test for Alzheimer's
How the test works
Developed by Fujirebio Diagnostics, the test measures the ratio of two proteins in the blood, which correlates with amyloid plaques in the brain—key indicators of Alzheimer's. Previously, these plaques were detected only through brain scans or spinal fluid analysis.
Implications for patients
FDA Commissioner Marty Makary highlighted the significance of this development, noting that Alzheimer's affects more people than breast and prostate cancer combined. With an estimated 10% of individuals aged 65 and older diagnosed with Alzheimer's, and projections indicating this could double by 2050, the test is seen as a crucial advancement.
Current treatments available
There are two FDA-approved treatments for Alzheimer's: lecanemab and donanemab. These drugs target amyloid plaques and have been shown to modestly slow cognitive decline, but they do not cure the disease. Advocates believe that earlier treatment could offer patients additional months of independence.
Clinical validation
In clinical studies, the blood test's results were largely consistent with PET brain scans and spinal fluid analysis, reinforcing its validity as a diagnostic tool.
Accessibility for patients
The test is authorized for use in clinical settings for patients exhibiting signs of cognitive decline and must be interpreted alongside other clinical information. Michelle Tarver from the FDA emphasized that this clearance is a significant step towards making Alzheimer's diagnosis easier and more accessible for patients in the U.S.
Understanding Alzheimer's disease
Alzheimer's is the most common form of dementia, progressively diminishing individuals' memories and independence over time.
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