In a development for Alzheimer’s research, the US Food and Drug Administration (FDA) has granted marketing clearance to the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, marking the first blood test in the United States officially cleared to help in diagnosing Alzheimer’s disease. The test is designed for adults aged 55 and older who are experiencing signs and symptoms of the disease.
The test, developed by Fujirebio Diagnostics Inc., measures two proteins pTau217 and beta-amyloid 1-42 in blood plasma. The ratio of these proteins strongly correlates with the presence or absence of amyloid plaques in the brain, one of the key indicators of Alzheimer’s.
How the Test Works
While the Lumipulse test does not directly measure amyloid plaques, it can indicate their potential presence. The FDA emphasized that the results must be interpreted alongside other clinical data, such as neurological exams, cognitive assessments, medical history, and imaging or spinal fluid tests.
“This is a much more simple screening test, with reasonable accuracy, to tell the physician that a person with cognitive decline has symptoms that are actually due to Alzheimer’s disease,” said Dr. Richard Isaacson, director of research at the Institute for Neurodegenerative Diseases in Florida.
Clinical Accuracy and Limitations
The FDA’s decision followed clinical trials involving 499 adults with cognitive impairment. Data showed that 91.7% of those who tested positive with the blood test also had amyloid plaques confirmed via PET scans or cerebrospinal fluid tests. Meanwhile, 97.3% of those who tested negative did not show amyloid buildup. However, the FDA acknowledged risks of false positives or negatives.
Hope for Early Intervention
Experts believe this FDA clearance could reshape Alzheimer’s diagnostics. “The ability to diagnose Alzheimer’s earlier with a simple blood test, like we do for cholesterol, is a game changer,” said Dr. Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation.
Fujirebio CEO Monte Wiltse stated, “An early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally.”
A Growing Health Crisis
According to the FDA, more than 10% of people aged 65 and older currently live with Alzheimer’s disease a number expected to double by 2050. The Alzheimer’s Association reports that over 42% of Americans over 55 may develop some form of dementia, making early detection crucial.
Dr. Maria Carrillo from the Alzheimer’s Association added, “For too long Americans have struggled to get a simple and accurate diagnosis. With today’s action by the FDA, we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier.”
Next Steps in Research and Awareness
While this marks a major milestone, medical professionals urge caution and continued education. “We need to advance education about what these tests mean and what they don’t,” said Dr. Isaacson. He stressed that results may vary depending on a patient’s symptoms and risk factors.
As Alzheimer’s research enters a new phase, the FDA’s approval of this blood test could make early, affordable, and accessible detection a reality offering new hope to millions.
