FDA grants 510(k) clearance to in vitro blood-based Alzheimer’s biomarker device

Key takeaways:

• Amyloid plaques are one telltale sign of Alzheimer’s disease pathology in blood plasma.
• A blood-based diagnostic method prevents invasive procedures like lumbar puncture for cerebrospinal fluid.

The FDA has granted 510(k) marketing clearance to the first in vitro blood-based biomarker diagnostic device for Alzheimer’s disease.

Fujirebio’s Lumipulse G pTau217/ -Amyloid 1-42 Plasma Ratio was developed for the early detection of amyloid plaques associated with AD in adults aged 55 years and older who show signs of the condition, according to releases from the FDA and manufacturer.

“While symptoms of Alzheimer’s disease present over many months or even years, current diagnostic approaches often require specialized imaging or invasive sampling of spinal fluid, which often delays diagnosis,” Jonathan R. Crowe, MD, MPH, assistant professor of neurology and public health sciences at the University of Virginia, told Healio. “This new evidence-based approach allows for simpler and faster blood testing to diagnose patients more quickly.”

The device measures two proteins that are telltale signs of AD pathology, pTau217 and -amyloid 1-42, which are found in blood plasma, calculating the numerical ratio of the levels of the two proteins; the ratio is associated with presence or absence of amyloid plaques in the brain, reducing the need for a PET scan.

According to the FDA, Lumipulse differentiates itself from other previously authorized or cleared tests in requiring a blood draw instead of a lumbar puncture to acquire cerebrospinal fluid samples.

The FDA had previously granted breakthrough device designation and permitted U.S-based marketing to Lumipulse for CSF sampling in 2022. Fujirebio submitted a regulatory filing for the Lumipulse in vitro blood-based device in September 2024.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” FDA Commissioner Martin A. Makary, MD, MPH, said in the FDA release. “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.”

The FDA’s decision on granting marketing clearance resulted from analysis of a multicenter clinical study of 499 individual plasma samples from cognitively impaired adults. Samples were tested by Lumipulse G pTau217/ -Amyloid 1-42 Plasma Ratio and compared with amyloid PET scan or CSF test results.

According to data cited in the FDA release, 91.7% of individuals with positive results were found to have presence of amyloid plaques by PET scan or CSF test results, while 97.3 % of those with negative results had a negative amyloid PET scan or CSF test results. Fewer than 20% of tested samples received an indeterminate result.