US FDA clears first blood test to detect Alzheimer's disease

The U.S. Food and Drug Administration said on Friday it had cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, making the test the first of its kind to detect the condition.

The blood test, branded as Lumipulse, will initially likely be used to rule out Alzheimer's, with positive results signaling the need for more advanced diagnostics.

Alzheimer's, which gradually destroys memory and thinking skills, is characterized by certain changes in the brain, including a buildup of amyloid beta plaques that result in loss of neurons responsible for transmitting information.

Fujirebio's device measures two specific proteins in the blood, pTau217 and β-amyloid 1-42, and calculates a ratio between them.

This ratio is linked to the presence of amyloid plaques in the brain, which is a key sign of Alzheimer's.

Detecting these plaques usually requires a PET brain scan or a spinal tap, which is a more invasive procedure to collect fluid from the spine.

Lumipulse only needs a blood draw, making it much easier and more comfortable for patients, the FDA said.

"Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined," said FDA Commissioner Martin Makary.

"Knowing that 10% of people aged 65 and older have Alzheimer's and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients."

Lumipulse and C2N Diagnostics' PrecivityAD2 were the top two performers when compared with four other commercial blood tests for Alzheimer's, according to a study led by researchers at Washington University School of Medicine.

The FDA has approved Biogen and partner Eisai's Leqembi and Eli Lilly's Kisunla for the treatment of this disease. (Reporting by Christy Santhosh in Bengaluru; Editing by Shreya Biswas and Shailesh Kuber)