The Food and Drug Administration approved on Friday the first blood test for diagnosing Alzheimer’s disease, opening up a quicker way for patients to get detected for the neurological condition and receive treatment.
The test, developed by Japan-based Fujirebio Diagnostics, uses a blood sample to detect the presence of plaques in the brain called amyloid that are thought to be linked to Alzheimer’s. The current method of detecting amyloid involves PET imaging scans of the brain that can be inconvenient and costly. Amyloid can also be detected in spinal fluid, but such tests are more invasive.
“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, in a statement. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
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