The U.S. Food and Drug Administration cleared a new blood test designed to aid in the early detection of Alzheimer’s disease in symptomatic adult patients, offering a less invasive alternative to traditional diagnostic procedures like spinal taps and PET scans.
FDA Clears Lumipulse Blood Test for Alzheimer’s Diagnosis
Food and Drug Administration (FDA) on May 16, 2025, the agency cleared the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. The in vitro diagnostic device measures specific proteins in human plasma to detect amyloid plaques associated with Alzheimer’s disease in adult patients aged 40 and older who exhibit signs and symptoms of cognitive impairment.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” FDA Commissioner Martin A. Makary said in a statement. Makary noted that 10% of people aged 65 and older have Alzheimer’s, and that number is expected to double by 2050.
How the Lumipulse Plasma Ratio Test Works
The test measures two proteins found in human plasma—pTau217 and β-amyloid 1-42—and calculates a numerical ratio of their levels. According to FDA data, this ratio correlates directly to the presence or absence of amyloid plaques in a patient’s brain.
Previously, similar FDA-authorized tests required cerebrospinal fluid (CSF) samples collected through an invasive lumbar puncture, commonly known as a spinal tap. Alternatively, physicians utilized amyloid positron emission tomography (PET) brain scans, which are costly, time-consuming, and expose patients to radiation. The new Lumipulse test requires only a simple blood draw, which reduces invasiveness and improves patient access.
“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” said Center for Devices and Radiological Health Director Michelle Tarver. Tarver called the clearance an important step in making diagnosis easier and more accessible for U.S. patients earlier in the disease progression.
Clinical Study Results and Accuracy
During its review, the FDA evaluated data from a multi-center clinical study involving 499 individual plasma samples from cognitively impaired adults. The results from the Lumipulse G test were compared against amyloid PET scans or CSF test results.
- Positive Result Accuracy: 91.7% of individuals with a positive test result confirmed the presence of amyloid plaques by PET scan or CSF test.
- Negative Result Accuracy: 97.3% of individuals with a negative result had a negative amyloid PET scan or CSF test.
- Indeterminate Results: Less than 20% of the 499 patients tested received an indeterminate result.
The findings indicate that the blood test reliably predicts the presence or absence of amyloid pathology at the time of testing in cognitively impaired patients. The FDA emphasizes that the test is intended for patients presenting at specialized care settings with signs of cognitive decline, and results must be interpreted alongside other patient clinical information and medical evaluations.
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