Individuals carrying the APOE ε4 allele have a higher likelihood of developing Alzheimer’s disease. Carriers—especially homozygous carriers—tend to have faster cognitive decline and earlier onset of symptoms. They are also at higher risk of developing Amyloid-Related Imaging Abnormalities (ARIA) upon treatment with newer disease-modifying therapies such as anti-amyloid therapies.
Investigation of APOE ε4 allele zygosity can be used in clinical research to further our understanding of neurodegenerative diseases. Our Research Use Only (RUO) immunoassay accurately identifies APOE ε4 zygosity—distinguishing between 0, 1, or 2 copies of the ε4 allele—with comparable precision to PCR-based methods.
Heading p-Tau217 and Alzheimer’s disease (AD)
Plasma p-Tau217 levels have shown correlation with amyloid pathology, which has implications for identifying neurodegenerative diseases such as AD. Elevated levels of p-Tau217 can help distinguish AD from other forms of dementia.
Measuring p-Tau217 may help to further research into AD pathology and flag samples from those with early-stage AD pathology.
Beckman Coulter is committed to developing a full suite of next-generation neurodegenerative disease tests. The proprietary technologies on the DxI 9000 Immunoassay Analyzer, coupled with the novel Lumi-Phos PRO substrate, has enabled development of precise, clinically relevant assays and shown capability to detect tarted neurological biomarkers on an automated, high-throughput platform.
Apolipoprotein (APOE) shuttles cholesterol and other lipids in the bloodstream and within the brain. It is also involved in axonal growth, synapse formation, and neural remodeling—all of which are important in learning, memory, and neural repair.
There are three main isoforms of APOE (ε2, ε3, and ε4) that differ in structure due to single amino acid substitutions at two specific locations (aa 112 and aa 158).
The APOE ε2 and ε3 proteins preferentially bind to high-density lipoproteins (HDL), while the APOE ε4 protein preferentially binds to very low-density lipoproteins (VLDL).
APOE ε4 is the most significant genetic risk factor for late-onset Alzheimer’s disease.
Identifying APOE ε4 zygosity with our RUO immunoassay enables research that supports earlier risk assessment, personalized care, and informed treatment decisions for those with or at risk of Alzheimer’s disease, while also aiding clinical trial stratification—without compromising analytical rigor.
The following results are derived from internal studies and are intended solely for informational purposes. These findings are not intended to serve as official specifications or guarantees of performance.
| Assay Characteristic | Access APOE ε4 (RUO) | |
| Assay format | Two-step sandwich | |
| Recommended sample type(s) | Plasma (K2-EDTA) | |
| Unit of measure | Relative Light Units (RLU) | |
| Open reagent pack stability | 2 to 10°C for 14 days | |
| Open QC vial stability | 2 to 10°C for 14 days | |
| Sample volume (uptake) | Access 2: 30 μL/ratio determination | DxI 9000: 20 μL/ratio determination |
| Time to first result (approximate) | Access 2: ~22 minutes | DxI 9000: ~15 minutes |
| Imprecision (%CV RLU Ratio)* | Access 2: ~7.9 - 13.4% | DxI 9000: ~6.4 - 10.4% |
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