The U.S. Food and Drug Administration (FDA) has officially approved a revolutionary blood test known as Lumipulse, which plays a crucial role in diagnosing Alzheimer’s disease, the most prevalent form of dementia. This marks a significant milestone as it is the first blood test to receive FDA clearance specifically for detecting Alzheimer’s disease, which currently afflicts over 7 million older Americans and is characterized by a decline in memory and cognitive abilities.
The Lumipulse test identifies abnormal protein clumps in the brain, referred to as amyloid plaques. These plaques interfere with brain cell functionality and serve as a defining feature of Alzheimer’s disease. Traditionally, physicians have relied on PET scans and spinal fluid tests to identify these amyloid plaques. However, these methods can be both costly and invasive, particularly the lumbar puncture procedure. In contrast, the Lumipulse test only requires a simple blood draw from patients aged 55 and older who exhibit symptoms of Alzheimer’s.
“Having a blood test just makes it so much easier in being able to make a diagnosis of Alzheimer’s disease,” remarked Charles Bernick, M.D., a neurologist affiliated with the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. While the manufacturer, Fujirebio Diagnostics, has yet to disclose the test's cost, the potential for easier access to diagnosis is clear.
The newly approved blood test measures two specific proteins present in the blood's liquid component, known as plasma. The test computes the ratio of these proteins to assess the probability of amyloid plaques being present in the patient’s brain, thereby reducing the reliance on PET scans. It’s imperative to note that this test is designed solely for older adults exhibiting symptoms of Alzheimer’s disease and is not intended as a screening tool for asymptomatic individuals.
According to the FDA, the results from the Lumipulse test should be interpreted in conjunction with “other clinical evaluations or additional tests” to make informed treatment decisions. In addition to brain imaging and lumbar punctures, physicians often conduct neurological and cognitive exams to arrive at an Alzheimer’s diagnosis. “It still becomes a diagnosis where you have to really look at the whole picture,” Dr. Bernick emphasized.
In recent years, the FDA has also approved two medications designed to treat Alzheimer’s disease: Kisunla (donanemab) and Leqembi (lecanemab). While these infusion drugs do not cure the disease, they can slow its progression in individuals during the early stages. It is essential to confirm the presence of amyloid plaques before prescribing these medications, as they come with potential risks such as swelling and bleeding in the brain. “They carry some risk. So if you’re going to use them or utilize them, you’ve got to be pretty sure the person has that protein in the brain,” Dr. Bernick noted.
Some Alzheimer’s experts have previously utilized non-FDA-approved blood tests to assist in diagnosing the disease. However, the FDA's endorsement of Lumipulse not only validates its accuracy but also paves the way for insurance coverage and broader accessibility. Expert groups have lauded the FDA’s announcement as a pivotal moment in Alzheimer’s diagnosis.
Howard Fillit, M.D., co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, stated that there has been a “tremendous need” for blood tests in this domain, asserting that the availability of such a test will “revolutionize clinical care and clinical research” for Alzheimer’s. “It’s going to reduce the cost of care and diagnosis, and it’s going to give people the opportunity to get a definitive diagnosis and enter into clinical trials,” Fillit shared with AARP.
Maria C. Carrillo, chief science officer and medical affairs lead at the Alzheimer’s Association, echoed this sentiment, highlighting that “for too long, Americans have struggled to get a simple and accurate diagnosis.” The FDA’s decision is seen as a significant step toward facilitating earlier and more accurate diagnoses for many individuals.
Looking ahead, Fillit anticipates the emergence of additional blood tests that could identify other critical aspects of Alzheimer’s disease, such as brain inflammation. Such advancements may enable healthcare providers to customize treatment plans as more therapies are developed. “It’s kind of going to look like cancer, where patients have a tumor, there’s a biopsy of the tumor, the tumor cells are taken to the lab, they’re characterized according to various biomarkers, and then a treatment plan with various drugs in combination is designed for the patient,” Fillit explained.
As we move forward, the approval of the Lumipulse test signifies the beginning of a new era in Alzheimer’s disease diagnosis and care, promising to enhance the lives of countless individuals affected by this challenging condition.
