A Blood Test for Alzheimer's? Yes.
The first FDA-cleared blood test for patients being assessed for Alzheimer's disease. Earlier detection of amyloid pathology in patients presenting with cognitive decline.
Simple Blood Test. Timely Insights. Improved Diagnostic Clarity for Patients with Cognitive Decline.
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-- 2026 Scientists’ Choice Awards Nominee for "Best New Clinical Diagnostics Kit or Assay of 2025"
Established amyloid tests are limited in routine clinical practice.
An estimated 7.4 million Americans are living with Alzheimer's disease1. Demand for clinical evaluation is increasing. Yet amyloid PET and CSF testing remain constrained by cost, accessibility and procedural burden.
Clinical assessment alone is not enough
In the early stages of Alzheimer's disease, relying solely on cognitive tests may result in incorrectly classifying 50-60% of patients2,3.
In early-stage patients, clinical diagnostic criteria are often inaccurate4.
PET and CSF don't fit every care pathway
PET imaging is expensive and often inaccessible. CSF biomarkers present practical barriers that limit their broad use5.
Many healthcare providers do not perform lumbar punctures. Some patients are ineligible due to medical contraindications, such as coagulopathies or the use of anticoagulant medications. These limitations hinder amyloid confirmation in memory clinics and other care settings4.
An indeterminate result is not an answer
Biomarker values exist along a continuum, so results near decision thresholds carry more classification uncertainty. Indeterminate results require confirmatory follow-up, such as CSF or amyloid PET testing, or a repeat blood test. The Global CEO Initiative on Alzheimer's Disease recommends limiting the indeterminate group to no more than 20% of tested individuals4.
Amyloid testing with a simple blood draw
In May 2025, the U.S. Food and Drug Administration cleared the first blood-based in vitro diagnostic test for Alzheimer's disease: the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio Test.
The test aids in the identification of patients with amyloid pathology associated with Alzheimer's disease.
How it works
The test measures two Alzheimer's disease-associated biomarkers in plasma, pTau 217 and β-Amyloid 1-42, and derives a ratio. It runs on the fully automated LUMIPULSE G1200 system.
The result helps predict the presence or absence of amyloid pathology associated with Alzheimer's disease. It can support clinical decision-making regarding additional diagnostic evaluations and patient management.
Benefits
- Earlier detection of amyloid pathology in patients presenting with cognitive decline
- Improves access to amyloid testing with a simple blood draw and automated immunoassay
- Combines pTau 217 and β-Amyloid 1-42 for greater accuracy in identifying amyloid PET positivity than plasma pTau 217 alone6
- Lowers costs compared to PET scan and is less invasive than CSF
- Reduces concerns related to PET imaging radioactivity and the invasiveness of CSF collection
Value for clinicians
Blood-based biomarkers allow specialized providers early and accurate assessments of patients with cognitive decline7,8. With high positive and negative predictive values, a blood test can accurately detect amyloid pathology, allowing healthcare providers to offer answers and guidance when addressing cognitive impairment concerns9.
Clinicians now have access to a simple, blood-based tool to help determine whether further testing or treatment for Alzheimer's disease is warranted.
Highly concordant with amyloid PET imaging and amyloid CSF ratio results
of individuals with a positive result have a positive CSF or amyloid PET scan result
PPV 91.8% (95% CI 87.8%-94.6%)
of individuals with a negative result have a negative CSF or amyloid PET scan result
NPV 97.3% (95% CI 93.9%-98.8%)
Clinical validation
The FDA determined the test to be substantially equivalent to amyloid PET brain scans and CSF tests. This was demonstrated in a clinical validation study of 499 patients aged 50 and above, reflecting the US demographic population, with cognitive impairment ranging from early to later stages of disease.
Why a ratio
In Fujirebio's clinical performance study, using the ratio of the two biomarkers correctly classified more patients into positive and negative test results by reducing the number of patients falling into the uncertain zone, compared to only measuring one biomarker.
Guidelines
The test demonstrated performance levels that meet the thresholds recommended for both confirmatory and triage use, as outlined in the Clinical Practice Guideline (CPG) and the Global CEO Initiative on Alzheimer's Disease (CEOi) consensus statement. [A7]
See the clinical performance data
Clinical test performance, result interpretation and LUMIPULSE G1200 specifications in one brochure.
What each result means
In patients aged ≥50 years presenting at a specialized care setting with signs
and symptoms of cognitive decline, results should be interpreted as follows:
| Result | Ratio | Interpretation* | Predictive value (95% CI) |
|---|---|---|---|
| Positive | ≥0.00738 | Consistent with patients LIKELY to have amyloid pathology. Result does not establish a diagnosis of AD or other cognitive disorders. | PPV 91.8% (87.8%-94.6%) |
| Indeterminate** | 0.00371-0.00737 | Consistent with patients UNCERTAIN to have amyloid pathology. Consider further testing. | |
| Negative | ≤0.00370 | Consistent with patients UNLIKELY to have amyloid pathology. Should investigate for other causes of cognitive decline. | NPV 97.3% (93.9%-98.8%) |
*Test results must be interpreted in conjunction with other patient clinical information. This test is not intended as a screening or stand-alone diagnostic assessment.
**19.6% of patients had an indeterminate result in the clinical study that supported the FDA clearance.
PPV, positive predictive value; NPV, negative predictive value.
Keep the interpretation guide at hand
Result interpretation plus sample collection, storage, handling and testing recommendations.
Fast, scalable ratio testing on the LUMIPULSE G1200
Cartridge-based ratio testing on the fully automated LUMIPULSE G1200 platform offers fast, scalable, high-quality results for comprehensive and cost effective AD assessments.
The test is available in various clinical laboratories around the US, including the largest reference laboratories.
Questions about implementation?
Fujirebio encourages laboratories to reach out with any questions they may have.
Learn more about the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio Test
For additional clinical tools and resources, contact us via this form.
References
- Alzheimer's Association. 2026 Alzheimer's disease facts and figures. Alzheimers Dement. 2026;22:e71345. doi:10.1002/alz.71345.
- Eichler T, et al. Rates of formal diagnosis of dementia in primary care: The effect of screening. Alzheimers Dement (Amst). 2015 Mar 29;1(1):87-93.
- Brooks BL, et al. Potential for misclassification of mild cognitive impairment: a study of memory scores on the Wechsler Memory Scale-III in healthy older adults. J Int Neuropsychol Soc. 2008 May;14(3):463-478.
- Plasma pTau 217/β-amyloid 1-42 ratio for enhanced accuracy and reduced uncertainty in detecting amyloid pathology. Brain. doi:10.1093/brain/awag001.
- Hampel H, et al. Blood-based biomarkers for Alzheimer's disease: Current state and future use in a transformed global healthcare landscape. Neuron. 2023 Sep 20;111(18):2781-2799.
- Niimi Y, et al. Combining plasma Aβ and p-tau217 improves detection of brain amyloid in non-demented elderly. Alzheimers Res Ther. 2024 May 23;16(1):115.
- Arslan B, et al. Blood-based biomarkers in Alzheimer's disease: moving towards a new era of diagnostics. Clin Chem Lab Med. 2024 Jan 23;62(6):1063-1069.
- Leuzy A, et al. Blood-based biomarkers for Alzheimer's disease. EMBO Mol Med. 2022 Jan 11;14(1):e14408.
- Schindler S, et al. Acceptable performance of blood biomarker tests of amyloid pathology: recommendations from the Global CEO Initiative on Alzheimer's Disease. Nat Rev Neurol. 2024 Jul;20(7):426-439.
