The FDA has granted 510(k) clearance to Fujirebio Diagnostics’ Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, the first in vitro diagnostic blood test approved to aid in the diagnosis of Alzheimer’s disease.
The test is cleared for use in adults aged 55 years and older who exhibit cognitive symptoms of Alzheimer’s.
Alzheimer’s disease has long been diagnosed through costly and invasive procedures such as amyloid positron emission tomography (PET) brain scans or cerebrospinal fluid (CSF) sampling via lumbar puncture.
PET scans expose patients to radiation and can run into thousands of dollars per scan, while CSF collection carries risks of headache, bleeding and infection. Both methods also face limited availability, especially in community and rural settings.
The Lumipulse test measures two key plasma biomarkers — phosphorylated tau at threonine 217 (pTau217) and β-amyloid 1-42 — and calculates their numerical ratio, which correlates with the presence of amyloid plaques in the brain (a hallmark of Alzheimer’s pathology).
By using a simple blood draw, the assay reduces reliance on imaging and invasive procedures, potentially expanding patient access to early and accurate diagnostic information.
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In Fujirebio’s press release announcing the FDA clearance, the company outlined that Alzheimer’s disease affects an estimated 7.2 million Americans today — a figure expected to nearly double to 14 million by 2060.
As a leading cause of disability and death, Alzheimer’s progresses silently over many years before symptoms appear. However, the absence of accessible, minimally invasive diagnostic tools means many individuals go undiagnosed until the disease is advanced, when treatment options are limited.
According to Fujirebio, the Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses the company’s fully automated LUMIPULSE G1200 instrument system, which is widely available in clinical laboratories throughout the US.
The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), which received FDA authorization in May 2022 for use with cerebrospinal fluid (CSF) samples.
Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio: Clinical Validation
In a validation study involving 499 cognitively impaired participants, the Lumipulse test demonstrated 91.7% accuracy in correctly identifying individuals with Alzheimer’s pathology and 97.3% accuracy in ruling out those without plaques, when compared against PET imaging and CSF benchmarks.
Less than 20% of tested patients scored an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result.
The findings show that the blood test can reliably detect the presence or absence of amyloid pathology linked to Alzheimer’s in cognitively impaired patients.
The performance metrics place Lumipulse among the top-performing blood-based assays evaluated to date.
According to the FDA, the test is intended for use in specialized care settings and should be interpreted alongside other clinical information.
The FDA and experts caution that blood biomarkers may yield false positives or negatives in the absence of clinical context, underscoring the need for physician oversight and complementary diagnostic tools.
A false positive result, when considered with other clinical data, may lead to an incorrect Alzheimer’s diagnosis. Conversely, a false negative result could lead to further unnecessary testing and delay effective treatment.
The FDA notes that the test is not intended for screening or as a standalone diagnostic tool and should be used alongside other clinical evaluations to guide treatment decisions.
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Impacts: Expanding Access
“Nearly 7 million Americans are living with Alzheimer’s disease, and this number is projected to rise to nearly 13 million by 2050,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, in the FDA’s press release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease.”
Speaking about the approval, FDA Commissioner Martin A. Makary, MD, MPH, said: “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined.”
“Knowing that 10% 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.”
Moreover, confirming amyloid status via blood draw could facilitate appropriate use of recently approved anti-beta-amyloid treatments such as Biogen/Eisai’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab-azbt), both of which mandate evidence of amyloid pathology prior to initiation.
However, the test is explicitly approved only for symptomatic individuals and is not intended for asymptomatic screening.
In December, Fujirebio partnered with Japanese pharmaceutical company Eisai to co-develop and advance blood-based biomarkers for neurodegenerative diseases, building on their earlier collaboration in CSF testing.
At the same time, Eisai and its partner Biogen unveiled projections this year to establish their Alzheimer’s drug Leqembi as a blockbuster by fiscal year 2027. Since its 2023 launch, Leqembi’s commercial uptake has been hampered by limited access to early diagnostic tools.
An Increasingly Competitive Landscape for Blood-Based Alzheimer’s Tests
Companies like Labcorp and Quest Diagnostics have also introduced blood-based tests targeting various biomarkers associated with Alzheimer’s disease. However, these are lab-developed tests and include markers such as beta amyloid, tau proteins, neurofilament light chain and other indicators of brain tissue damage.
Other companies — including C2N Diagnostics and a partnership between Roche and Eli Lilly — are pursuing FDA clearance for blood-based Alzheimer’s assays similar to Fujirebio’s.
“The lack of effective, accessible and minimally invasive diagnostics for Alzheimer’s disease contributes to its late diagnosis and inadequate treatment,” said Monte Wiltse, president and CEO at Fujirebio Diagnostics, Inc.
“The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an Alzheimer’s disease diagnosis in early stages of the disease, when interventions are more effective.”
He also shared that Fujirebio is developing additional assays to broaden access to diagnostic tools and strengthen the foundation for “early, more effective treatment.”
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