The Alzheimer’s Association estimates that 7.2 million Americans ages 65 and older—that’s about one in nine people—are living with Alzheimer's, per a 2025 report. The crippling neurological disease damages neurons in the brain that are responsible for memory, language, and thinking skills. There’s no cure, and the process of receiving a formal diagnosis is taxing, not to mention expensive. However, that could all change thanks to a new blood test called Lumipulse.
On May 16, the U.S. Food & Drug Administration (FDA) approved the first-ever Alzheimer’s blood test. Lumipulse is the brainchild of Fujirebio Diagnostics, a subsidiary of Japan’s H.U. Group.
"Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million," said Michelle Tarver, MD, PhD, director of the Center for Devices and Radiological Health, in a statement. "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."
Keep reading to learn more about this revolutionary diagnostic method, and learn who qualifies for access.
RELATED: Experts Warn This Common Medication May Be Linked to Dementia Risk.
The diagnostic tool screens for amyloid plaques, which are considered the "hallmark sign" of Alzheimer’s.
Lumipulse, a blood test that screens for early detection of amyloid plaques associated with Alzheimer’s disease, has received the FDA’s stamp of approval. An endorsement of this caliber is groundbreaking, as Lumipulse is the only diagnostic tool of its kind currently on the market.
So, how does Lumipulse work? Per the FDA’s release, the test measures two types of proteins (pTau217 and β-amyloid 1-42) found in blood plasma. Their level ratios determine the presence or absence of amyloid plaques in the brain. Positive test results signal the onset of Alzheimer’s disease.
Historically, to diagnose Alzheimer’s, doctors reference a patient’s medical history and conduct neurological and cognitive function exams before confirming the results via brain scans and/or spinal tap fluid procedures. The latter is time-consuming, involves radiation exposure, and can run up quite a medical bill. Lumipulse aims to simplify this process with a simple blood test—and most importantly, increase diagnosis accessibility and affordability.
"For too long Americans have struggled to get a simple and accurate diagnosis, with today’s action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier," Maria Carrillo, PhD, chief science officer and medical affairs lead at the Alzheimer’s Association, said in a statement.
RELATED: As You Get Older, Sleeping Less Can Increase Alzheimer's Risk, New Study Shows.
Lumipulse proved successful in a clinical trial.
Before earning FDA clearance, a clinical trial tested the blood samples of 499 cognitively impaired adults to evaluate them for Alzheimer’s disease. They corroborated their findings with additional testing, such as brain imaging and spinal fluid analysis.
Of the adults with positive Lumipulse test results, nearly 92 percent had the presence of amyloid plaques validated by their brain scans or fluid tests. Meanwhile, 97.3 percent of people with negative Lumipulse results also had a negative brain scan or fluid analysis.
In response to the data, the FDA said, "These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired."
"Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined," said FDA commissioner Martin A. Makary, MD, in a statement. "Knowing that 10 percent of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients."
According to the FDA, Lumipulse is considered safe. The only known associated risks are the possibility of receiving false-positive or false-negative test results, in which case your doctor may request a retest.
RELATED: Hearing Loss Could Be a Sign of These 2 Brain Conditions, Research Finds.
Who qualifies for Lumipulse?
"Blood-based biomarkers are reshaping how we identify and understand Alzheimer’s disease," said Carrillo in a statement provided by the Alzheimer's Association. "At the same time, there are important questions for healthcare professionals to consider; in particular, who should be tested and when."
According to FDA guidelines, Lumipulse is an option for adults aged 55 and older who are exhibiting signs and symptoms of Alzheimer's. This means patients have already undergone preliminary baseline cognitive assessments under the discretion of their doctor.
"The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information," says the FDA.
It’s unclear how much Lumipulse will cost.
