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BioWorld - Saturday, March 21, 2026
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Home » Roche secures CE mark for blood test to identify ApoE4 carriers
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Roche secures CE mark for blood test to identify ApoE4 carriers

March 17, 2026
By Shani Alexander
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Roche Holding AG received CE Mark approval for its Elecsys Apolipoprotein E4 (ApoE4) biomarker test, an in vitro diagnostic immunoassay to identify the ApoE4 gene variant from a blood sample. With APOE4 considered as the strongest genetic risk factor for developing Alzheimer’s disease, the test provides a fast, reliable way to determine whether an individual carries the genetic variant without the need for DNA‑based genotyping.
BioWorld Medical technology Regulatory Diagnostics Neurology/psychiatric Europe

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