FDA Clears First Blood Test to Aid in Alzheimer’s Diagnosis

The U.S. Food and Drug Administration (FDA) has cleared the first laboratory-based blood test to aid in the diagnosis of Alzheimer’s disease—a major milestone in the effort to detect the disease earlier and more easily. FDA clearance means the test meets federal standards for safety and effectiveness and can now be used in certified clinical labs to help evaluate Alzheimer’s risk.

How does the test work?

The test, called the Lumipulse G β-Amyloid Ratio (1-42/1-40), is manufactured by Fujirebio Diagnostics. It works by measuring two forms of amyloid-beta in the blood, proteins that clump together to form plaques in the brains of people with Alzheimer’s. The test is intended for adults aged 55 and older who are being evaluated for signs of cognitive impairment.

How does this test differ from existing Alzheimer’s blood tests on the market?

Until now, confirming amyloid plaque buildup required either a PET scan—which is costly and not widely available—or a lumbar puncture to obtain cerebrospinal fluid. The new blood test offers a simpler and less invasive option for clinicians to determine whether someone’s memory or thinking problems may be due to Alzheimer’s disease or another form of dementia.

In a clinical study of nearly 500 individuals, the Lumipulse test was shown to accurately predict the presence or absence of amyloid plaques when compared to PET imaging, which remains the current standard for confirming amyloid in the brain.

Other blood tests on the market, including the PrecivityAD® test and ALZpath Dx™, use similar approaches to measure proteins such as amyloid-beta and phosphorylated tau to assess Alzheimer’s risk. While Lumipulse is the first to receive FDA clearance for aiding diagnosis, these other tests are available in the U.S. as laboratory-developed tests, meaning they can be used in certified labs under specific regulatory guidelines.

Can this test diagnose Alzheimer’s?

No blood test can definitively diagnose Alzheimer’s disease. While the Lumipulse test has been cleared as a laboratory-developed test, it is not intended for screening the general population or diagnosing Alzheimer’s on its own. Instead, it should be used alongside clinical assessment and other diagnostic tools to help inform a diagnosis.

How much will it cost?

FDA clearance of the Lumipulse test is an important step toward broader insurance reimbursement, including potential Medicare coverage. While coverage policies have not yet been finalized, regulatory approval opens the door for the Centers for Medicare & Medicaid Services to begin evaluating the test for reimbursement. This could help expand access to testing, particularly for older adults who are most affected by Alzheimer’s disease. However, out-of-pocket costs for patients remain unclear and may vary depending on lab processing fees, provider charges, and individual insurance plans.

Blood tests like Lumipulse are also expected to play a critical role in identifying individuals who may be eligible for emerging Alzheimer’s therapies, particularly those that target amyloid buildup.

New research on the horizon

As new treatments and diagnostic tools come to the forefront, BrightFocus remains committed to funding innovative research aimed at improving early detection and driving forward the next generation of Alzheimer’s care.

“BrightFocus Foundation’s Alzheimer’s Disease Research program has long supported the development of Alzheimer’s diagnostics, including early research into blood-based biomarkers and new technologies to detect amyloid and tau pathology. The FDA’s approval of Lumipulse reflects years of progress in making Alzheimer’s diagnosis more accessible, accurate, and timely,” said BrightFocus President and CEO Stacy Pagos Haller.

Learn more about our Alzheimer’s Disease Research program and our funded research on Alzheimer’s diagnostics and therapeutics.