A first-of-its-kind blood test developed by Malvern-based Fujirebio Diagnostics to help diagnose Alzheimer’s disease has received clearance from the U.S. Food and Drug Administration, writes Courtenay Harris Bond for PhillyVoice.
The blood test detects the abnormal protein brain deposits associated with the disease. It is intended for individuals aged 55 and older who are already showing signs of Alzheimer’s.
“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,” said Center for Devices and Radiological Health Director Michelle Tarver.
The test, named Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, was approximately 92 percent as accurate in diagnosing Alzheimer’s as a brain scan or spinal fluid test. Roughly 97 percent of individuals whose blood test came back negative also received negative results from the other two tests.
Early detection of Alzheimer’s helps individuals receive the full benefits of treatment and also opens the possibility of getting into clinical trials.
The blood test “will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective,” said Monte Wiltse, President and CEO of Fujirebio Diagnostics.
Read more about Fujirebio Diagnostics’ new blood test for Alzheimer’s and how it works in PhillyVoice.
_________
