FDA Approves First Blood Test That Could Diagnose Alzheimer’s Disease

There is a new advance in the detection of Alzheimer’s disease. A blood test that can detect Alzheimer’s disease was approved by the US’s Food and Drug Administration (FDA). This could change the way this form of dementia is diagnosed and paves the way for earlier treatment.

The test is for people who are 55 and older who are already showing signs of memory loss and cognitive decline, reported NPR. The results of the blood test shows whether the person has the amyloid plaques – proteins that form in the spaces between brain cells – that confirm Alzheimer’s.

“I think the blood test is going to really revolutionize the way people with Alzheimer’s are cared for and diagnosed,” Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation told NPR.

While blood tests have been used in labs, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test that was developed by the diagnostic company Fujirebio is the first one to be cleared by the FDA for commercial use, according to a press release from the administration.

Diagnosing Alzheimer’s
This is welcome news because of the prevalence of the disease. “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,”  FDA commissioner Martin A. Makary, M.D., M.P.H, said in the press release. 

In fact, 10 percent of people who are 65 and older have Alzheimer’s and the number is expected to double by 2050. This progressive disease robs people of memory, cognition, and the ability to perform simple everyday tasks.

Currently, diagnosing Alzheimer’s is not that easy or accurate, according to NPR. Primary care physicians only correctly diagnose the disease 60 percent of the time and specialty neurologists only 70 to 80 percent.

Testing fluid from a spinal tap is an effective way to get an accurate diagnosis but it is invasive, and patients tend to avoid it. A PET scan is considered the best way to detect amyloid plaques, but it is expensive and not available in many places.

Early Diagnosis Means Early Treatment
The new test is over 90 percent accurate in detecting  amyloid plaques and the results were confirmed by PET scans or cerebrospinal fluid tests. Having this tool available means that more people will be able to receive treatment while their symptoms are still mild. An early diagnosis means that patients may be eligible to receive one of the amyloids reducing drugs that are currently used.

The blood test will be readily available in rural and underserved areas. “Blood tests have given us an opportunity to really democratize this kind of testing,” Maria Carrillo, chief science officer of the Alzheimer’s Association told NPR.

According to a statement from the Alzheimer’s Association, nearly four in five Americans want to know if they have the disease before it impacts their lives and would take a simple blood marker test to find out.