The Food and Drug Administration has approved a new blood test for Alzheimer’s that can detect a presence in the brain of amyloid plaque, which has been considered a key indicator of the disease.
The test is not meant for routine screening but can be pivotal for a diagnosis when cognitive problems are causing doctors to suspect Alzheimer’s. Roche, the test’s manufacturer, announced the FDA’s decision Monday. The test was developed in collaboration with Eli Lilly.
The FDA approved the first Alzheimer’s blood test in 2025. That test, sold by Fujirebio, measures two proteins. Roche said its test is the first to measure a single protein, which serves as a “biomarker” for amyloid.
Blood tests are less intrusive at verifying amyloid than PET scans and cerebrospinal fluid draws. Roche said in a news release that a blood test will be easier to access for patients visiting with their primary care doctors, rather than a specialist. The relative ease of the test will help patients and their families rule Alzheimer’s in or out at an earlier stage, the company said.
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