A blood test made by a Malvern company that can help diagnose Alzheimer's disease, a form of dementia affecting more than 7 million Americans, has been cleared by the U.S. Food and Drug Administration.
The blood test is used to detect abnormal protein deposits in the brain that are associated with Alzheimer's. The test is for people 55 and older who are already showing signs of the disease, according to a statement from the FDA. It is the first blood test of its kind to receive FDA clearance.
"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," Center for Devices and Radiological Health Director Michelle Tarver said in the release.
The test, made by Fujirebio Diagnostics, has a complicated name: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. It measures two proteins, amyloid and tau, that build up in the brain, kill neurons and cause permanent damage leading to Alzheimer's. These proteins can begin to collect as much as 20 years before symptoms of the disease emerge.
The blood test was about 92% as accurate as a brain scan or a spinal fluid test in diagnosing people with Alzheimer's. More than 97% of people who tested negative on the blood test also had negative results on the brain scan and spinal fluid test, the FDA said.
Early detection of the disease is crucial for people to benefit from treatment and opens the possibility of participating in clinical trials, the Alzheimer's Association says.
Alzheimer's is the most common form of dementia, ultimately causing people to lose some of their brain function, including memory and language. It affects 1 in 10 people over 65 and 1 in 3 people over 85. The Alzheimer's Association projects that nearly 13 million Americans will be living with the disease by 2050.
"The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment," Monte Wiltse, President and CEO of Fujirebio Diagnostics, said in a statement. 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."
There is no single test for Alzheimer's. Currently, doctors diagnose the disease through a combination of medical and symptom review, physical exam, mental status testing, neuropsychological tests, and interviews with friends and family members. Sometimes people will undergo a cerebrospinal fluid test to check for amyloid and tau proteins in the fluid. Brain imaging is also used.
The blood test will "revolutionize" the way people with Alzheimer's are diagnosed and cared for, Dr. Howard Fillit, chief science officer at the Alzheimer's Drug Discovery Foundation, told NPR.