The FDA Just Approved an Alzheimer's Disease Blood Test

If you or someone you love is concerned about Alzheimer’s disease, the process of detecting its presence can involve a series of tests. As the Mayo Clinic’s history of the process reminds us, this is a step forward from the previous method of testing, which could only be accomplished posthumously. Based on a recent decision from the FDA, however, the process of diagnosing Alzheimer’s disease could become a lot more efficient.

This week, the FDA announced that it was approving the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio for use in testing blood for Alzheimer’s disease. The device works by comparing the amount of two different proteins in human blood, which can reveal whether or not amyloid plaques are present in the brain of the person being tested. The device was designed to be used to test people age 55 and over.

“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 Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, in a statement.

In an article on the device’s approval for The Washington Post, Daniel Gilbert and Rachel Roubein described the process as “less risky and more accessible” than previous methods of diagnosing Alzheimer’s disease.

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Howard Fillit of the Alzheimer’s Drug Discovery Foundation predicted that the approval of this new system is “going to dramatically change clinical care” and called it “an incredible advance.” And this Lumipulse device might not be alone in this new area of Alzheimer’s detection; Gilbert and Roubein noted that two other companies — C2N Diagnostics and Quanterix — are also working on creating blood tests for Alzheimer’s disease.