In a breakthrough for Alzheimer’s diagnosis, the U.S. Food and Drug Administration (FDA) has approved the first blood test capable of detecting early signs of the disease. The test, called Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, was developed by Fujirebio Diagnostics and is designed for individuals aged 55 and older who are experiencing signs of cognitive decline.

This test marks a significant advancement as it identifies amyloid plaques in the brain—a hallmark of Alzheimer’s disease—using a simple blood sample. Previously, detecting these plaques required either costly PET scans or invasive procedures such as a lumbar puncture to collect cerebrospinal fluid (CSF). The Lumipulse test eliminates those hurdles by analyzing two key proteins in the blood: pTau217 and β-amyloid 1-42. The ratio of these proteins is then used to determine whether amyloid buildup is likely present in the brain.

“This is a game changer,” said Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation. “Being able to diagnose Alzheimer’s early with a simple blood test, similar to how we test for cholesterol, will allow more patients to access treatment options that could delay or even prevent the disease.”

The FDA’s decision to grant marketing clearance was based on a multicenter clinical study involving 499 adults who showed signs of cognitive impairment. The results showed high accuracy: 91.7% of those who tested positive were confirmed to have amyloid plaques through traditional testing, while 97.3% of those who tested negative did not have the plaques. Only a small percentage of test results (less than 20%) were inconclusive.

Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, emphasised the importance of the approval. “Nearly 7 million Americans are living with Alzheimer’s, and this number is projected to rise to nearly 13 million. This blood test represents a major step in making diagnosis more accessible for patients earlier in the disease process.”

The Lumipulse test is intended for use in specialised healthcare settings and should be considered alongside other clinical evaluations. With this approval, the path to early diagnosis and timely intervention for Alzheimer’s disease could become significantly easier and less invasive for millions of patients and their families.