FDA clears first Alzheimer’s blood test

USA – The first-ever FDA-cleared blood test to detect signs of Alzheimer’s disease is set to change how doctors diagnose and manage the condition.

Developed by diagnostic company Fujirebio, the Lumipulse test is now approved for use in patients aged 55 and older who show memory loss or other cognitive symptoms.

This breakthrough test identifies amyloid plaques– clumps of harmful protein found in the brains of people with Alzheimer’s.

Detecting these plaques helps confirm whether a person’s memory problems are linked to the disease.

Until now, amyloid detection required expensive PET scans or invasive spinal taps, both of which are not widely available and can be uncomfortable for patients.

With the FDA’s green light, the Lumipulse test becomes the first blood-based diagnostic for Alzheimer’s that can be marketed widely.

Experts believe this innovation will allow for earlier, more accurate diagnoses, especially in rural or underserved communities where advanced imaging technology is limited.

“This is going to revolutionize how Alzheimer’s is diagnosed,” said Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation. “Blood tests like this can help primary care doctors make better decisions faster.”

Currently, general practitioners correctly diagnose Alzheimer’s only about 60% of the time, while specialists reach around 70–80%.

Experts say the new test could push accuracy above 90%, giving more patients a timely diagnosis while their symptoms are still mild and potentially treatable.

Early detection is crucial, as two FDA-approved drugs now exist that can slow the buildup of amyloid in the brain.

These treatments are most effective in the early stages of Alzheimer’s, making this new testing option even more important.

The Alzheimer’s Association also emphasized the test’s potential to make diagnosis more accessible.

“Blood tests have given us an opportunity to really democratize this kind of testing,” said Dr. Maria Carrillo, the association’s chief science officer.

To guide healthcare providers on how to talk to patients about test results and treatment options, the Alzheimer’s Association is developing a set of counseling guidelines, expected to be released this summer.

As an estimated 7.2 million Americans live with Alzheimer’s, this new test offers hope for earlier detection, better care, and wider access, marking a major milestone in the fight against this devastating disease.