The blood test is nearly 92% as accurate as a PET scan or spinal tap in detecting patients with Alzheimer’s
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NEED TO KNOW
- The FDA greenlit marketing for the first blood test to help diagnose Alzheimer’s disease
- The test measures two proteins, beta-amyloid and p-tau217, which are hallmarks of the disease
- Experts believe this will increase access to Alzheimer’s detection and reduce reliance on expensive PET scans and invasive spinal taps
The Food and Drug Administration has given marketing clearance to the first blood test to help diagnose Alzheimer’s disease.
On May 16, the agency announced clearance of the test — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio — manufactured by the Pennsylvania-based biotechnology company Fujirebio Diagnostics. The test works by measuring proteins beta-amyloid and p-tau217, which are believed to be hallmarks of Alzheimer’s disease.
Alzheimer’s is a degenerative brain disease that is caused by complex brain changes following cell damage. It progressively affects memory, thinking and behavior seriously enough to interfere with daily tasks.
The blood test was cleared for use in people age 55 and older who exhibit signs and symptoms of the disease. The FDA said this new test can help increase access to Alzheimer’s disease detection and reduce reliance on PET scans or spinal taps, which are more expensive and invasive.
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“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” Dr. Michelle Tarver, director of the Center for Devices and Radiological Health, said 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.”
The FDA said that it conducted a study that evaluated 499 plasma samples from patients who were cognitively impaired and compared the results of the blood test with the results by PET scan or spinal tap.
