Elecsys® Apolipoprotein E4 Plasma

IVD For in vitro diagnostic use.

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Immunoassay for the qualitative determination of the APOE e4 carrier status in human blood plasma

Alzheimer’s disease (AD) is a progressive, neurodegenerative disease associated with cognitive dysfunction and behavioral impairments. It represents the most common form of dementia, contributing to 50–60 % of cases.1

Apolipoprotein E (ApoE) is a 317-amino-acid protein that mediates lipid transport and cholesterol homeostasis in the peripheral and central nervous systems.2 It is encoded by the APOE gene and occurs as 3 major isoforms, ApoE2, ApoE3, and ApoE4.3

Carrying the e4 allele has been associated with a higher likelihood of developing AD, lower average age at symptom onset, and faster cognitive decline, including accelerated progression from mild cognitive impairment (MCI) to Alzheimer’s dementia, compared with non-carriers.3,4 Published evidence indicates that APOE e4 carriers, particularly homozygotes, experience a higher incidence of amyloid-related imaging abnormalities (ARIA) during currently available treatment with monoclonal anti-amyloid antibodies than non-carriers.5-7

A faster patient journey

Until now, determining genetic risk has relied on expensive and time-consuming DNA testing. The Elecsys® ApoE4 test offers a simpler alternative, using a minimally-invasive blood sample to identify whether an individual carries the ApoE4 variant.

In the general population, the ApoE4 variant is present in only around 13.7% of people,8 meaning a large majority do not carry it. For these individuals, the test eliminates unnecessary genetic testing, streamlining the diagnostic process and lowering costs. For those people who are identified as carrying the variant—found in around 40% of those diagnosed with Alzheimer’s8—follow-up genetic testing can confirm their status and provide more detailed insights for a subgroup of carriers.

Benefits at a glance

Benefits at a glance

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Overview

Ordering information

 

Product specification9

Value

Systems

cobas® e 402 analytical unit, cobas® e 801 analytical unit

Testing time

18 minutes

Sample material

K2 EDTA and K3 EDTA plasma.

Plasma tubes containing separator gel can be used.

Sample volume

4 µL

Testing principle

2-steps sandwich assay

Onboard stability

16 weeks

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References

  1. World Health Organization (WHO). Dementia Fact Sheet [Internet; cited 2026 Feb 17]. Available from: https://www.who.int/news-room/fact-sheets/detail/dementia.
  2. Kloske CM, et al. Advancements in APOE and dementia research: Highlights from the 2023 AAIC Advancements: APOE conference. Alzheimers Dement. 2024;20(9):6590-6605.
  3. Serrano-Pozo A, et al. APOE and Alzheimer’s disease: advances in genetics, pathophysiology, and therapeutic approaches. Lancet Neurol. 2021;20(1):68-80.
  4. Najm R and Jones EA, Huang Y. Apolipoprotein E4, inhibitory network dysfunction, and Alzheimer's disease. Mol Neurodegener 2019;14(1):24. doi.org/10.1186/s13024-019-0324-6.
  5. van Dyck CH, et al. Lecanemab in Early Alzheimer’s Disease. N Engl J Med. 2023;388(1):9-21. 
  6. Sims JR, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512-527. 
  7. Sperling RA, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer's Association Research Roundtable Workgroup. Alzheimers Dement. 2011;7(4):367-385. 
  8. Guo T, et al. Molecular and cellular mechanisms underlying the pathogenesis of Alzheimer’s disease. Mol Neurodegeneration. 2020;15:40.
  9. Elecsys® Apolipoprotein E4 Plasma method sheet 09697888500V1.0 English. Roche Diagnostics GmbH.
  10. Crean S., et al. Apolipoprotein E ε4 prevalence in Alzheimer's disease patients varies across global populations: a systematic literature review and meta-analysis. Journal of Alzheimer's Disease (JAD), 2011; 26(3): 479–492.