Alzheimer’s, Diseases & Disorders

FDA Clears Revolutionary Blood Test for Alzheimer’s: Krieger Klein Alzheimer’s Research Center Director Shares Impact and Next Steps

A promotional image isn't necessary when using the hero - with headline on image. The image used in the hero will be automatically pulled into components where this article is pulled into.

Date

July 11, 2025

The U.S. Food and Drug Administration (FDA) has approved the LumipulseⓇ blood test, the first blood biomarker test for Alzheimer’s disease—a landmark moment in dementia care that experts say could transform early detection and patient care. Unlike costly PET scans or invasive lumbar punctures, this simple blood draw measures pTau217 and ß-Amyloid 1-42 ratios to detect amyloid plaques and tau tangles-key hallmarks of Alzheimer’s, making diagnosis more accessible than ever.[1].

A Leap Forward in Accuracy

In clinical studies, the Lumipulse^® test demonstrated exceptional performance:

91.7% of individuals with positive blood test results had amyloid plaques confirmed via PET scans or cerebrospinal fluid tests.
97.3% of individuals with negative test results showed no signs of pathology[1].

However, as Dr. Beeri notes, it’s not a crystal ball. “This test cannot predict Alzheimer’s in people without symptoms and focuses only on amyloid and tau, not other factors like vascular disease or inflammation”. Still, its accuracy exceeds that of many traditional cognitive assessments and represents a major step towards accessible diagnostics [2] for the estimated 6.5 million Americans currently living with Alzheimer’s, with that number projected to nearly double by 2050 [1][3].

Why Early Detection Matters

Early detection gives patients and families critical advantages—timely medical care, access to clinical trials, and the ability to plan ahead. Dr. Beeri highlights this impact:

“With approximately 90% accuracy, this blood test enables clinicians to identify Alzheimer’s disease earlier in its course, once initial symptoms have become noticeable.”

This can improve outcomes and quality of life for patients and families, offering hope where barriers once stood.

Rutgers Brain Health Institute’s Role in Advancing Alzheimer Research

At the Brain Health Institute’s Krieger Klein Alzheimer’s Research Center, Dr. Beeri’s team is already working to close these diagnostic gaps through pioneering research on metabolic factors, digital cognitive tools, and other biological pathways linked to neurodegeneration.

Her studies have revealed that:

Type 2 diabetes and metabolic disorders significantly affect brain structure and function, contributing to cognitive decline and neurodegeneration[6][7].
Digital cognitive assessments, including smartphone-based tools, can detect early cognitive changes and may complement blood biomarkers for even earlier detection[4][5].
Synaptic loss, a key contributor to dementia, often occurs independently of amyloid or tau buildup, underscoring the need for broader diagnostic approaches[8][9].

As Dr. Beeri notes:

“At the Krieger Klein Alzheimer’s Research Center, our research is dedicated to advancing early detection and intervention strategies for Alzheimer’s disease. 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 for high-risk individuals more effectively.”

Addressing the Test’s Limitations

While groundbreaking, the Lumipulse^® test is not without limitations. It focuses on detecting amyloid plaques and tau tangles and misses other Alzheimer related factors like vascular disease, neuroinflammation, synaptic impairment, and brain insulin resistance [10]. Dr. Beeri explains:

“The new test has two main limitations: 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, neuroinflammation, synaptic impairment, and brain insulin resistance.”

Cutting-edge Alzheimer’s Research at the Rutgers Brain Health Institute

Recognizing the need for next-generation solutions, some examples of research at Rutgers include:

Neuroinflammation and vascular disease, showing how metabolic dysfunction contributes to brain insulin resistance and Alzheimer’s risk[10][7].
Intranasal insulin and GLP-1 agonists, potential treatments for brain insulin resistance not addressed by current blood tests[10].
Behavioral studies, revealing how learning about Alzheimer’s risk affects anxiety and motivation, reinforcing the need for patient support alongside diagnostic tools[12][13].
Novel Therapies for Alzheimer’s and other neurodegenerative diseases focused on transporting powerful antibody-based drugs into the brain [15].

The Krieger Klein Alzheimer’s Research Center’s commitment to studying Alzheimer’s and related disorders in different ethnic populations is also reflected in Rutgers’ groundbreaking cohort studies like SAMENA and BRAINY-NJ. These cutting-edge studies are designed to ensure that diverse populations are represented in research and have access to new diagnostics and treatments [14].

A Vision for the Future

Ultimately, Dr. Beeri envisions a world where Alzheimer’s is no longer a looming threat:

“It is my dream that one day we’ll all have to choose another disease to study, because we will have resolved Alzheimer’s disease”[14].

The FDA’s approval of the Lumipulse^® blood test represents a powerful first step in this journey. By integrating accessible diagnostics with innovative research—from metabolic therapies to digital monitoring—The Rutgers Brain Health Institute is paving the way for more comprehensive, effective, and equitable Alzheimer’s care.