Roche (RHHBY) has received CE Mark approval for the Elecsys ApoE4 test, the first in-vitro diagnostic immunoassay that can identify carriers of the ApoE4 genetic variant using a simple blood sample.
The test offers a faster and more accessible way to determine whether a patient carries ApoE4- a variant present in up to 60% of people diagnosed with Alzheimer's disease- without immediately requiring DNA-based genetic testing.
Alzheimer's disease is the most common cause of dementia worldwide, accounting for up to 70% of cases. The ApoE4 gene variant is one of the strongest known genetic risk factors for late-onset Alzheimer's, and identifying carrier status has become increasingly important as new disease-modifying therapies rely on genetic profiling to guide treatment decisions.
The Elecsys ApoE4 test uses a minimally invasive blood draw to distinguish between carriers and non-carriers. For patients who test negative, the result can eliminate the need for confirmatory genetic testing. For those who test positive, follow-up genetic sequencing can provide more detailed information- a step that is becoming essential as certain Alzheimer's treatments carry higher risk for ApoE4 carriers, particularly those with two copies of the gene.
Matt Sause, CEO of Roche Diagnostics, said the approval represents an important step toward simplifying Alzheimer's diagnostic pathways. By helping clinicians quickly identify ApoE4 carriers among patients with cognitive decline, the test aims to streamline decision-making and improve patient management.
The new assay joins Roche's growing portfolio of blood-based Alzheimer's biomarkers, including the recently CE-marked Elecsys pTau181 test, which helps rule out amyloid pathology. Together, these tools support earlier detection and more personalized care, and can be run on the large installed base of Roche diagnostic instruments across countries that accept the CE mark.
Roche says the Elecsys ApoE4 test demonstrated 100% concordance with genetic sequencing in a multicenter study of more than 600 participants, correctly identifying all carriers and non-carriers. The company views the approval as a key milestone in preparing healthcare systems for wider use of emerging Alzheimer's treatments.
RHHBY has traded between $34.75 and $60.85 over the past year. The stock closed Friday's trading session (March 13, 2026) at $50.12, down 3.49%.
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