Sunday

08-03-2025 Vol 2041

FDA Approves First Blood Test for Alzheimer’s Disease Diagnosis

Alzheimer’s disease is a heartbreaking condition that affects over 7 million Americans.

As the Baby Boomer generation ages, projections indicate this number could rise to 13 million by the year 2050.

In a significant advancement for early diagnosis, the U.S. Food and Drug Administration (FDA) has approved the Lumipulse Plasma Ratio test, marking the first blood test that can assist in diagnosing Alzheimer’s disease.

Dr. Michelle Sorweid, a geriatric physician and cognitive disorder specialist at University of Utah Health, underscores the importance of this breakthrough.

“The blood test is an easy and non-invasive way to add supporting diagnostic information to a workup for cognitive disorders,” she states.

In addition, the results from this blood test are available within weeks, a stark contrast to other diagnostic evaluations that can take months due to scheduling delays.

Understanding the implications of this blood test is crucial for patients, their families, and those at a heightened risk for developing Alzheimer’s.

However, it is equally essential to recognize the limits of what this test offers.

Alzheimer’s disease primarily affects adults who are 65 and older, and it is recognized as the leading cause of dementia, resulting in a gradual decline in cognitive abilities, including memory and thinking skills.

The disease is progressive, meaning symptoms worsen over time.

Early signs often include memory loss and cognitive issues, which are usually assessed through mental status tests.

If a mental status assessment indicates cognitive impairment, the traditional diagnostic path has typically involved brain imaging tests or cerebrospinal fluid examinations.

While these methods may still be performed to rule out other conditions—such as a stroke or presence of a brain mass—the Lumipulse test simplifies the diagnostic process by utilizing a straightforward blood draw.

This blood test analyzes the presence of two specific proteins that accumulate in the brains of individuals with Alzheimer’s: beta-amyloid and phosphorylated tau proteins.

The detection of these proteins aligns with the identification of amyloid plaques in the brain, which is a critical marker of Alzheimer’s disease-related degeneration.

To put it into perspective, one can visualize the brain as a network of roads bustling with activity.

In a healthy brain, information, memories, thoughts, and emotions travel smoothly.

However, in an Alzheimer’s-affected brain, the build-up of debris in the form of beta-amyloid creates traffic jams, slowing down communication.

Meanwhile, the structural components—the tau proteins—undergo damage and become tangled, further hindering the brain’s functionality.

This blood test serves as a GPS, alerting physicians to potential roadblocks on the path to cognitive health.

Additionally, ARUP Laboratories, the University of Utah’s blood bank and laboratory partner, is developing its own blood test to identify phosphorylated tau proteins, akin to the Lumipulse test.

However, it has yet to receive FDA approval.

This test, like Lumipulse, aims to correlate tau protein presence with amyloid plaque accumulation, indicating the prospect for Alzheimer’s.

In the context of public sentiment, a survey by the Alzheimer’s Association reveals that 4 in 5 Americans prefer to be informed about possible Alzheimer’s diagnosis prior to experiencing symptoms that impact their daily life.

Currently, the Lumipulse test is designated for older adults who are already exhibiting symptoms of cognitive impairment.

Its ease of administration through a simple blood draw makes it a non-invasive, cost-effective way to collect supporting diagnostic data for patients beginning their care journey.

“Blood tests are an added tool to the diagnostic process, not necessarily a substitute for other testing methods,” Dr. Sorweid explains.

However, these blood tests can be as effective at identifying the disease as traditional methods like spinal taps or amyloid PET scans.

As the Lumipulse test stands as the first of its kind to gain FDA approval, several more promising blood tests for Alzheimer’s are awaiting evaluation by the FDA, some of which have shown equal or superior performance in predicting the disease.

image source from:healthcare

Benjamin Clarke