FDA Approves First Blood Test for Alzheimer's Disease Diagnosis

The U.S. Food and Drug Administration (FDA) has granted clearance to the first-ever blood test designed to detect Alzheimer’s disease, marking a significant advancement in early diagnosis of the debilitating condition.

The newly approved device, named Lumipulse, is an in-vitro diagnostic test that identifies the presence of amyloid plaques in the brain—a biological hallmark of Alzheimer’s. This technology is intended for use in adults over the age of 55 who may be exhibiting early signs and symptoms of cognitive decline.

Traditionally, amyloid plaques have been detected using PET scans, which are not only expensive and time-consuming but also expose patients to doses of radiation. The Lumipulse blood test offers a less invasive and potentially more cost-effective alternative, reducing reliance on PET imaging or other procedures that may be uncomfortable or inaccessible for some patients.

“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,” stated Dr. Michelle Tarver, Director of the Center for Devices and Radiological Health. She noted that nearly seven million Americans currently live with Alzheimer’s, a number projected to rise to almost 13 million in the coming decades.

The FDA’s decision was influenced by data from a clinical study involving 499 cognitively impaired adults. The Lumipulse test was able to identify the presence of amyloid plaques in 91.7% of cases, leading regulators to conclude that it can “reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test.”

Despite its promise, the FDA also cautioned about the risk of false positives—instances where the test might incorrectly indicate Alzheimer’s. This could lead to misdiagnosis or unnecessary treatment in some patients. As such, the agency stressed the importance of comprehensive clinical assessment alongside the use of the blood test.

In a statement, FDA Commissioner Marty Makary highlighted the growing impact of Alzheimer’s:

• Over 10% of people aged 65 and older are currently affected
• The prevalence is expected to double by 2050
• Alzheimer's now affects more people than breast cancer and prostate cancer combined

Makary expressed hope that innovations like the Lumipulse test will help address the disease’s expanding reach by enabling earlier intervention. Early diagnosis is critical as it opens the door to timely care strategies, better patient outcomes, and informed decision-making for individuals and families facing Alzheimer’s.

The approval of this blood test could represent a turning point in the way health professionals diagnose and manage Alzheimer’s disease, potentially improving quality of life for millions of Americans as the nation grapples with an aging population.