Roche receives CE mark for first IVD immunoassay blood test to identify carriers of ApoE4, a genetic variant present in up to 60% of patients diagnosed with Alzheimer's disease

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The Elecsys ApoE4 test is the first CE marked in-vitro diagnostic immunoassay to identify individuals carrying the ApoE4 genetic variant using a simple blood sample.The test offers a fast, reliable and accessible option to rapidly differentiate between carriers and non-carriers.The test eliminates the need for confirmatory genetic testing in the proportion of Alzheimer's patients who do not carry the ApoE4 variant.- Accessed in March 2026
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[6] Serrano-Pozo A, Das S, Hyman BT. APOE and Alzheimer's disease: advances in genetics, pathophysiology, and therapeutic approaches. Lancet Neurol 2021;20(1):68-80. doi:10.1016/S1474-4422(20)30412-9. https://pubmed.ncbi.nlm.nih.gov/33340485/ - Accessed in March 2026
[7] Najm R, 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. https://pubmed.ncbi.nlm.nih.gov/31186040/ - Accessed in March 2026
[8] van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. N Engl J Med2023;388(1):9-21. doi:10.1056/NEJMoa2212948. - https://pubmed.ncbi.nlm.nih.gov/36449413/ - Accessed in March 2026
[9] Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA 2023;330(6):512-527. doi:10.1001/jama.2023.13239. https://pubmed.ncbi.nlm.nih.gov/37459141/ - Accessed in March 2026
[10] Sperling RA, Jack CR Jr, Black SE, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer's Association Research Roundtable Workgroup. Alzheimers Dement. 2011;Jul;7(4):367-385. doi: 10.1016/j.jalz.2011.05.2351. https://pubmed.ncbi.nlm.nih.gov/21784348/ - Accessed in March 2026
[11] Elecsys® Apolipoprotein E4 Plasma method sheet 09697888500V1.0 English. Roche Diagnostics GmbH.

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Pasquale Monteleone
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Yvette Pettilon
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Kathryn Ager
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