Alzheimer's Diagnosis Milestone: What a New Blood Test Means for Patients, Caregivers

The U.S. Food and Drug Administration (FDA) has approved the first-of-its-kind blood test to aid in diagnosing Alzheimer’s disease — a milestone for clinicians and patients alike who may soon benefit from a more accessible, less invasive path to early detection. For many, this development could mark a turning point in how the disease is understood, diagnosed and managed.

G. Peter Gliebus, M.D., a neurologist and director of Cognitive and Behavioral Neurology at Marcus Neuroscience Institute, part of Baptist Health, at Boca Raton Regional Hospital, sees the approval of the “Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio” blood test for adults aged 55 years and older as a major step forward.

“I was genuinely excited to hear about the FDA’s approval of this blood test,” says Dr. Gliebus. “It represents a significant advancement in simplifying the evaluation of patients who present with symptoms that might suggest Alzheimer’s disease.”

G. Peter Gliebus, M.D., neurologist and director of Cognitive and Behavioral Neurology at Marcus Neuroscience Institute, part of Baptist Health, at Boca Raton Regional Hospital.

Unlike traditional diagnostic tools that require a lumbar puncture or specialized imaging like PET scans, this new test only requires a blood sample. It measures two key proteins — tau and beta-amyloid — that are closely associated with Alzheimer’s pathology.

Understanding the Science Behind the Blood Test

To understand why this test matters, it helps to know what these proteins do.

“Tau proteins help maintain the structure of neurons, while beta-amyloid plays a role in communication between them,” Dr. Gliebus explains. “In Alzheimer’s disease, abnormal forms of these proteins accumulate in the brain, disrupting normal cellular processes and leading to the characteristic symptoms of memory loss and cognitive decline.”

The ability to measure these proteins in blood offers a much-needed window into these changes—without the physical and emotional burden of more invasive testing. Ease of access is one of the most promising aspects of this new tool.

“This significantly simplifies the testing process,” Dr. Gliebus notes. “It eliminates the need for procedures like lumbar punctures, which can deter some patients from seeking evaluation.”

The impact is far-reaching: the test opens doors for early evaluation and intervention, especially among populations who may avoid or delay testing due to cost, accessibility, or fear of invasive procedures.

What This Means for the Future of Alzheimer’s Care

According to data provided by the test manufacturer, only about 20 percent of patients would require additional confirmatory testing after receiving this blood test. That means the vast majority could get a strong diagnostic indication with just a simple blood draw.

“This is a breakthrough in diagnostic accuracy,” says Dr. Gliebus. “It can correctly diagnose many patients while also reliably excluding individuals who do not have Alzheimer’s.”

As promising as this new tool is, Dr. Gliebus underscores the importance of building a framework around how it’s used.

“We need clear clinical guidelines,” he says. “Specifically, will results from this test alone be enough to qualify patients for treatment? Or will additional testing still be required?”

Continued innovation and research will also aim to further reduce the number of patients who need follow-up with more invasive tools. If you or a loved one are experiencing memory concerns or cognitive changes, talk to your healthcare provider about new diagnostic options.