The FDA today cleared the first blood test to help diagnose Alzheimer’s disease, potentially paving the way for earlier detection and treatment of the dreaded neurological condition.
Why it matters: The test, developed by Fujirebio, is a more affordable alternative to PET scans or spinal taps now used to diagnose the disease, and could be incorporated into physician office visits.
The big picture: More than 7 million Americans over age 65 have Alzheimer’s, and the caseload continues to grow. Diagnosing the condition early can allow patients to take advantage of new drugs to slow disease progression.
- “Alzheimer’s disease impacts too many people … I am hopeful that new medical products such as this one will help patients,” FDA Commissioner Marty Makary said in a statement.
Where it stands: Alzheimer’s is typically determined by the presence of proteins in the brain called amyloid plaques that are detected via costly PET scans or invasive spinal taps.
- The newly-cleared blood test would be less costly with fewer risks.
Zoom in: More than 90% of 499 blood samples from cognitively impaired people that tested positive in a clinical trial were later confirmed by PET scans to have amyloid plaques.
- Fewer than 20% of patients in the sample got an inconclusive test result from the blood test.
- The main risk of the test is false positive or negative results, FDA noted in its release.
The test should be used in conjunction with other clinical information and other tests should be taken to determine treatment options, FDA said.
By MAYA GOLDMAN/Axios