On 16th May, 2025, the U.S. FDA gave approval to the first blood test to help doctors diagnose Alzheimer’s disease. The test, known as Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, is an in vitro diagnostic device that helps detect amyloid plaque biomarkers, a key indicator of Alzheimer’s pathology, in adult individuals aged 55 and older who show signs or symptoms of the condition.
A New Chapter in Alzheimer’s Diagnosis:
The approved blood test is an in vitro diagnostic device designed to detect amyloid plaques in the brain, one of the earliest and most defining features of Alzheimer’s disease. The blood test was approved for adult individuals aged 55 years and older with signs and symptoms of cognitive decline. The blood test typically measures key biomarkers in plasma that are related to Alzheimer’s. This offers healthcare providers (HCPs) additional support to help diagnose the condition early.Why This Matters?
Until now, the most reliable Alzheimer’s disease diagnostic methods have included costly and invasive procedures like PET scans or cerebrospinal fluid analysis. The approval of a simple blood test represents a more accessible, affordable, and less invasive option for millions of individuals.“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of individuals aged 65 and older have Alzheimer’s, and that by 2050 that number is likely to double, I am hopeful that new therapeutic drugs such as this one will help larger population.”
Clinical Performance of Lumipulse G pTau217 Test:
Recent studies show that the Lumipulse G test is highly accurate:- 91.7% of people with a positive result later showed amyloid plaques on PET scans or CSF studies.
- 97.3% of those who tested negative had no plaques at all.
- Fewer than 20% of the 499 patients tested received an indeterminate result.
A Step Forward in Early Intervention:
Diagnosing Alzheimer’s early opens up the door to timely treatment, better planning, and the highest quality of life. Now that the FDA has cleared the test, doctors can use it much sooner, and that matters because the number of cases is expected to double by 2050.This development also aligns with the global healthcare community’s growing focus on biomarker-driven diagnostics. This provides personalized and more efficient care in combating dementia.
Looking Ahead:
The FDA green light opens the door for further innovation in neurodegenerative disease diagnostics. With increasing awareness, an older population, and evolving medical technology, the approval of the first Alzheimer’s blood test may indicate the beginning of a new era in brain health diagnostics and efficient care accessibility.Reference:
US FDA