The Food and Drug Administration (FDA) has officially approved a groundbreaking blood test designed to detect plaques in the brain that are associated with Alzheimer’s disease. This innovative test, known as Lumipulse, offers a less invasive and more accessible diagnostic tool for identifying this neurodegenerative condition. By measuring two specific proteins found in the blood plasma, Lumipulse determines the presence of amyloid plaques in the brain, which are a hallmark of Alzheimer’s.
Traditionally, diagnosing Alzheimer’s has involved costly and invasive procedures, such as spinal taps and brain scans that expose patients to radiation. The Lumipulse test simplifies this process by requiring only a simple blood draw. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, emphasized the significance of this advancement, stating, “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.”
With nearly 7 million Americans affected by Alzheimer’s, competition is intensifying among companies striving to develop next-generation diagnostic tests. Lumipulse is manufactured by Fujirebio Diagnostics, a subsidiary of Japan’s H.U. Group. Other companies, such as C2N Diagnostics and Quanterix, are also working on blood-based tests for Alzheimer’s, highlighting the growing interest in this area of healthcare.
Howard Fillit, a geriatrician and chief science officer of the Alzheimer’s Drug Discovery Foundation, voiced his excitement about the development, stating, “The idea that there’s a blood test for Alzheimer’s disease is unfathomable to me. It’s just an incredible advance.” He noted that primary care physicians can now order a blood test for patients experiencing memory problems, simplifying the referral process to neurologists.
While there are some laboratory-developed blood tests for Alzheimer’s already available, the FDA does not review most lab tests before they are utilized by patients. Lumipulse stands out as the first blood test to receive formal approval from the agency. According to the Alzheimer’s Association, blood tests have been increasingly integrated into clinical settings, marking a significant shift in how Alzheimer’s is diagnosed.
The FDA specifies that the Lumipulse test is intended for patients at specialized care centers who exhibit signs and symptoms of cognitive decline. The test results should be considered alongside other clinical information about the patient. Brian Balin, a professor of neuroscience and experimental neuropathology, advises that the blood test should not be used for individuals without signs of cognitive decline due to the risk of false results. He stated, “You would have to see some level of change there that then would indicate, ‘Let’s get a blood test.’”
The presence of amyloid plaques in the brain is a significant indicator of Alzheimer’s disease, although the role these plaques play is still debated among neurologists. Since 2021, the FDA has approved three anti-amyloid drugs, including Kisunla by Eli Lilly and Leqembi by Eisai and Biogen. While clinical trials suggest that these drugs can modestly slow disease progression, they have not been shown to reverse the condition and remain controversial due to their risks and high costs.
The FDA has cleared Lumipulse for patients aged 55 and older who exhibit symptoms of cognitive decline, based on a clinical study involving 499 plasma samples from individuals with cognitive impairment. While Lumipulse provides a promising diagnostic avenue, the FDA has noted the main risks associated with the test are false positives and false negatives. In the study, 91.7% of patients who tested positive for amyloid were confirmed to possess the plaques through brain scans or spinal taps, while 97.3% of those with negative results were confirmed not to have the plaques.
