1st Blood Test to Diagnose Alzheimer’s Wins FDA Nod

The U.S. Food and Drug Administration (FDA) has cleared for marketing the first in-vitro diagnostic (IVD) device that tests blood to help diagnose Alzheimer’s disease.

The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, developed by Fujirebio Diagnostics, offers early detection of amyloid plaques associated with Alzheimer’s disease in patients 55 years and older who exhibit signs and symptoms of the disease.

The test measures the pTau217 and β-amyloid 1-42 proteins found in human plasma, and calculates the numerical ratio of those two proteins’ levels. This ratio correlates to the presence or absence of amyloid plaques in the brain, which reduces the need for a PET scan—a costly, time-consuming option that exposes patients to radiation.

Similar FDA-authorized/cleared tests, one from the same company as this new test, are used with cerebrospinal fluid (CSF) samples collected through an invasive lumbar puncture. The Lumipulse test requires a simple blood draw.

During review of the Lumipulse test, the FDA evaluated data from a multi-center clinical study of 499 individual plasma samples from cognitively impaired adults. The samples were tested by the Lumipulse test and compared with amyloid PET scan or CSF test results.

91.7% of individuals with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of individuals with negative results had a negative amyloid PET scan or CSF test result. Less than 20% of the 499 patients tested received an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result.

These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, MD, M.P.H. “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.”

“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” added Center for Devices and Radiological Health Director Michelle Tarver, MD, Ph.D. “[This] 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.”