On May 16, 2025, the U.S. Food and Drug Administration granted clearance to Japan-based Fujirebio for its blood test designed to aid in the diagnosis of Alzheimer’s disease—a pivotal regulatory milestone that industry observers say could reshape the screening landscape for neurodegenerative disorders.

The FDA’s greenlight allows Fujirebio’s test, which runs on its widely deployed Lumipulse platform, to be marketed to U.S. patients displaying signs of cognitive decline. The move is being hailed by clinicians and researchers as a major step toward earlier, less invasive, and more accessible diagnosis of Alzheimer’s, a disease that affects millions of Americans and has traditionally required costly and invasive diagnostic tools like spinal taps or brain imaging.

The Lumipulse system is a “fully automated” instrument capable of processing up to 120 tests per hour on blood and other biological samples, making it particularly suitable for clinical laboratory use. Fujirebio’s test works by measuring concentrations of two specific proteins in the bloodstream associated with the accumulation of amyloid plaques in the brain—a molecular hallmark of Alzheimer’s pathology. According to CBS News, these biomarkers serve as critical indicators, providing physicians with essential diagnostic data that has, until now, been attainable only through PET scans or analysis of spinal fluid.

Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, underscored the significance of the development, stating, “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,” a sentiment echoed across much of the neurology community.

The test, however, is not for everyone. The FDA has specified that Fujirebio’s blood assay is intended exclusively for adults aged 55 and older who present symptoms of cognitive decline in specialized care settings. This targeted use reflects ongoing concerns about both the specificity of biomarker-driven diagnostics and the complexities of clinical decision-making for neurodegenerative conditions with overlapping symptoms.

Fujirebio’s FDA submission included data from a study involving 499 adults with cognitive impairment. The research compared the results of the Lumipulse blood test with established diagnostic standards, including brain amyloid imaging and cerebrospinal fluid assays. The findings, as reported by CBS News, demonstrated comparable performance, positioning the blood test as a viable first-line tool in the diagnostic pipeline.

This regulatory milestone comes amid a broader surge in research on blood-based Alzheimer’s diagnostics. Washington University School of Medicine in St. Louis, for instance, recently reported in Nature Medicine that their own blood test for the disease performed as well as FDA-approved cerebrospinal fluid assays at detecting amyloid buildup, offering promise that simple blood draws could soon replace more invasive procedures. The study’s authors suggest that such assays could radically reduce both the cost and complexity of Alzheimer’s screening, while simultaneously expanding access.

The industry’s evolution is synchronizing with a pharmacological pipeline that now includes two FDA-approved Alzheimer’s therapies in the United States, according to Washington University School of Medicine. The convergence of advanced diagnostics and emerging treatments is fueling optimism among clinicians, patients, and payers alike.

Still, there are significant hurdles ahead. Blood-based biomarker testing must prove its consistency across diverse populations and care settings, and clinicians are urging thoughtful integration into complex diagnostic workflows. For now, the FDA’s clearance of Fujirebio’s test marks what many experts describe as a turning point in the battle against neurodegeneration, signaling not only a technical achievement but also a broader shift toward preventive, patient-centered care. As the technology becomes more embedded in routine practice, the industry will be watching closely to see how these advances affect diagnosis rates, treatment decisions, and ultimately, patient outcomes.