Japanese-developed Lumipulse test offers a faster, less invasive way to detect early signs of Alzheimer’s using a simple blood sample.
The U.S. Food and Drug Administration (FDA) has approved the first blood test designed to help diagnose Alzheimer’s disease in certain adult patients, according to CBS News. The test was developed by Japanese company Fujirebio and works with the automated Lumipulse system, which is already available in clinical laboratories across the country.
This authorization marks a breakthrough in the field of neurological diagnosis. Until now, blood tests for Alzheimer’s were sold without formal FDA approval. The newly approved test enables doctors to detect the buildup of amyloid plaques in the brain—a hallmark of Alzheimer’s—by measuring two key proteins in blood plasma samples.
According to the FDA, the test is intended for adults aged 55 and older who show symptoms of cognitive impairment, and must be administered exclusively in specialized clinical settings.
“Today’s approval is an important step for Alzheimer’s diagnosis, allowing earlier access to this tool for patients in the United States,” said Dr. Michelle Tarver, director at the FDA’s Center for Devices and Radiological Health.
The Lumipulse system, also developed by Fujirebio, is a fully automated platform capable of processing up to 120 tests per hour, including blood and other clinical samples. This efficiency could make it a revolutionary tool in daily medical practice, significantly cutting the wait time for reliable results.
The blood test works by measuring the ratio of two proteins: pTau 217 and β-amyloid 1-42. Both are linked to the presence of amyloid plaques in the brain. In a study submitted by Fujirebio to the FDA, 499 plasma samples from patients with cognitive decline were analyzed and compared to results from brain scans and cerebrospinal fluid tests.
The results showed strong agreement. In 91.7% of cases where the blood test was positive, traditional methods also detected amyloid plaques. Likewise, in 97.3% of cases with negative blood test results, plaques were not detected by other methods. These findings supported the company’s application for FDA approval, submitted in 2023.
The FDA emphasized that this test is not intended for general screening or widespread use. It is specifically recommended for patients who are already showing signs of cognitive decline and are under specialized medical care. It is not a preventive test or one intended for consumer access.
“We designed our Lumipulse G pTau 217/β-Amyloid 1-42 test to help doctors and patients with signs of cognitive impairment receive an earlier diagnosis, when interventions may be more effective,” Fujirebio said in a statement last year during its FDA regulatory filing, as reported by CBS News.
This approach reflects the urgency of acting in the early stages of Alzheimer’s, when current treatments—although limited—can have a greater impact. The FDA’s official approval also boosts confidence in the test’s accuracy and validation compared to unregulated alternatives.
Before this approval, several labs in the U.S. sold similar tests under a different regulatory framework for so-called Laboratory-Developed Tests (LDTs), which are subject to less oversight. This has raised concerns in the scientific and public health communities.
Under the Biden administration, the FDA sought to impose stricter regulations on LDTs, arguing that many treatable conditions share symptoms with Alzheimer’s. Without proper validation, the agency warned, these tests could lead to misdiagnoses and endanger patients.
“The FDA’s regulatory framework was designed half a century ago, when lab-developed tests were simpler, low-volume, and locally focused,” health officials explained in January, according to CBS News.
However, these new regulations were challenged in court. In March 2025, a federal judge in Texas struck down the rule following a lawsuit from the American Clinical Laboratory Association (ACLA).
“This is a victory that protects patient access to critical testing services and removes burdensome regulations that would have negatively impacted the clinical lab system in this country,” the ACLA stated after the ruling.
With this approval, Fujirebio sets a precedent for the development and sale of high-complexity diagnostic tests under official FDA scrutiny. This move may encourage other manufacturers to pursue the same regulatory pathway, raising the quality standards for diagnosing neurodegenerative diseases.
While the new blood test does not replace traditional methods like brain imaging or spinal fluid analysis, it offers a less invasive, more accessible alternative with faster results. Both the medical community and patients now have access to a scientifically validated tool—critical in a field where early detection can make all the difference.
