FDA Approves First Blood Test to Diagnose Alzheimer’s Disease

(Bloomberg) -- US regulators have approved the first blood test to help diagnose Alzheimer’s disease, potentially making it easier to find and treat patients with the mind-robbing disease that affects nearly 7 million Americans. 

The test made by Fujirebio Diagnostics Inc., a unit of Japan’s H.U. Group Holdings Inc., was cleared for people 55 years and older who exhibit signs and symptoms of the disease, the US Food and Drug Administration said in a statement. It is designed for the early detection of amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer’s, the most common form of dementia in the elderly.

The development and approval of blood tests that can spot which patients are likely to have toxic amyloid in their brains has been viewed as a critical step toward making drugs to treat the condition more widely accessible. While the test is approved for people who are already exhibiting signs of cognitive impairment, studies show amyloid begins accumulating in the brains of some patients years before symptoms begin.  

To qualify for drug treatment, patients now generally get a specialized PET scan to detect amyloid in their brains or undergo a cerebrospinal fluid test. The PET scans are expensive and require specialized equipment, while the spinal fluid tests involve an invasive procedure. 

The need for these tests has slowed the rollout of new Alzheimer’s drugs like Leqembi from Eisai Co. and Biogen Inc., and Eli Lilly & Co.’s Kisunla.

Fujirebio’s newly approved test, called Lumipulse, only requires a blood draw, making it less invasive and potentially easier for patients to access. It’s unclear how much it will cost or when it will be available. It’s intended for patients at a specialized care setting who are experiencing cognitive decline, according to the FDA.

The blood test shouldn’t be used alone to diagnose the disease, in part because of the risk of false positive or negative results, the agency said. Other clinical evaluations and additional tests should be used to determine treatment options, it said.

More stories like this are available on bloomberg.com

©2025 Bloomberg L.P.