FDA Clears Blood Test ⁣for early Alzheimer’s Detection

⁢ Updated May ⁣16, 2025

The Food and Drug Administration ⁣(FDA) has cleared the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first in vitro diagnostic device using a ⁣blood test to assist in diagnosing Alzheimer’s disease. This new test is intended for adults aged 55 and older who show signs and symptoms of the disease, aiding in‍ the early detection of amyloid⁤ plaques, a key indicator of ⁣Alzheimer’s.

The Lumipulse test measures the ratio of pTau217 and β-amyloid 1-42 proteins in plasma, correlating this ratio to the presence of amyloid plaques in⁣ the brain.⁣ this offers a less invasive alternative ⁤to positron emission tomography (PET) scans and cerebrospinal fluid (CSF)⁢ tests, which require spinal taps.

Michelle Tarver, director of the ⁣Center for Devices and Radiological ⁤Health, said the clearance is an crucial step for Alzheimer’s disease diagnosis, possibly making‍ it easier and more accessible for U.S. patients to get diagnosed earlier. The Alzheimer’s Association estimates that nearly 7 million Americans are living with Alzheimer’s disease, and ⁤this number is projected to rise to nearly ⁤13 ⁤million.

The FDA ‍evaluated data from⁣ a clinical study involving‍ 499 plasma ⁢samples from ‍cognitively impaired adults. The lumipulse G pTau217/ß-amyloid 1-42 Plasma Ratio‍ results were compared with amyloid PET⁢ scan and CSF test results.

The study found ⁤that 91.7% of individuals with positive Lumipulse test results also⁤ had amyloid plaques⁣ detected by PET scan or CSF test. Conversely, 97.3% of individuals with negative Lumipulse results had negative amyloid PET scans or CSF⁣ test results. Less than 20% of the patients tested received⁤ an indeterminate result.

The FDA noted that the risks associated with the⁣ Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio include the possibility of false positive and false ⁣negative results.False positives could lead to inappropriate diagnosis and unnecessary treatment, while false negatives could delay effective treatment. ⁢The agency emphasized that the test is not intended as a screening tool or stand-alone diagnostic test.

⁣ ‍ “Alzheimer’s ‍disease impacts‍ too ⁣many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner⁤ Martin A. 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.”
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What’s next

the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is now available for use in specialized care settings for patients⁣ exhibiting signs and symptoms ⁤of cognitive decline. The‍ FDA continues to encourage further research⁣ and progress of innovative tools for ⁣the early detection and diagnosis of Alzheimer’s disease.