FDA Clears First Blood Test for Alzheimer’s Diagnosis, a “Turning Point” in Early Detection
Rutgers researcher says the advancement supports early and accurate detection in a simpler, less invasive, and more accessible way
Alzheimer’s disease is a form of dementia that impacts memory, cognition, and behavior, with symptoms eventually reaching a level where they disrupt daily activities. The U.S. Food and Drug Administration has approved the first blood test to aid in the diagnosis of Alzheimer’s disease - an advancement that could dramatically improve how and when patients are diagnosed.
Michal Schnaider Beeri, director of the Herbert and Jacqueline Krieger Klein Alzheimer’s Research Center within the Rutgers Brain Health Institute, commented that the Lumipulse blood test marks a major milestone in efforts to diagnose the disease more easily.
“Previously, confirming a diagnosis often required costly brain imaging or invasive procedures, which could be barriers for many patients,” Schnaider Beeri said.
Unlike expensive positron emission tomography (PET) scans or invasive lumbar punctures, the new blood test measures the ratio of two proteins, pTau217 and ß-Amyloid 1-42, which are implicated in Alzheimer’s disease.
“This blood test offers a simpler, less invasive, and more widely accessible way to support accurate detection of amyloid plaques and tau tangles, two of the main pathological markers of Alzheimer’s disease,” Schnaider Beeri said.
In clinical studies, the blood test showed outstanding results, with 91.7% of individuals who tested positive having amyloid plaques confirmed through PET scans or cerebrospinal fluid tests, and 97.3% of those with negative results showing no signs of pathology. The test’s accuracy surpasses many conventional cognitive assessments and marks a significant step toward making diagnostics more accessible for nearly 7 million U.S. residents living with Alzheimer’s, a number expected to nearly double by 2050.
Early detection gives patients and families critical advantages, such as timely medical care, access to clinical trials, and the ability to plan ahead.
“With approximately 90% accuracy, this blood test enables clinicians to identify Alzheimer’s disease, once initial symptoms have become noticeable,” said Beeri, adding that this can improve outcomes and quality of life for patients and families, offering hope where barriers once stood.
However, Beeri cautioned that the new test has limitations. She said. “It does not reliably predict future dementia in people without symptoms, limiting its use for prevention, and it focuses only on amyloid plaques and tau tangles, while Alzheimer’s and related dementias involve other factors like vascular disease and neuroinflammation.”
At the Krieger Klein Alzheimer’s Research Center in the Rutgers Brain Health Institute, scientists are working to close these diagnostic gaps through pioneering research on metabolic factors, digital cognitive tools, and other biological pathways linked to neurodegeneration.
“Our research is dedicated to advancing early detection and intervention strategies for Alzheimer’s disease,” Schnaider Beeri said. “The introduction of this blood test aligns closely with our ongoing efforts to integrate new biomarkers into our cohort studies and clinical trials. It enhances our ability to identify at-risk individuals and tailor interventions more effectively.”
The Krieger Klein Alzheimer’s Research Center’s commitment to studying Alzheimer’s and related disorders in diverse ethnic populations is also reflected in Rutgers’ cohort studies, such as one focused on the South Asian, Middle Eastern and North African populations at risk for Alzheimer’s disease and related dementias and the Brazilian Aging in New York–New Jersey Study. These cutting-edge studies are designed to ensure that diverse populations are represented in research and have access to new diagnostics and treatments.
Schnaider Beeri said she envisions a world where Alzheimer’s can be diagnosed early and cured.
Explore more of the ways Rutgers research is shaping the future.
