The pharmaceutical company Roche has received CE approval for the Elecsys ApoE4 test. It is the first in vitro diagnostic immunoassay (IVD) to identify carriers of the genetic variant ApoE4 using a simple blood sample.

The ApoE4 gene variant is associated with an increased risk of late-onset Alzheimer’s disease and occurs in about 40 to 60 percent of Alzheimer’s patients. Alzheimer’s disease accounts for up to 70 percent of dementia cases worldwide and is expected to affect nearly 150 million people by 2050.

Until now, ApoE4 carrier status has been confirmed by molecular DNA tests. The new test offers a fast, reliable and minimally invasive alternative with a blood sample. It enables efficient filtering of non-carriers, so genetic testing only needs to be done when needed. In the case of identified carriers, follow-up genetic testing can provide more detailed findings.

The test is gaining importance in the context of disease-modifying therapies (DMTs), as ApoE4 carriers – especially homozygous ones – have a significantly higher risk of amyloid-related imaging abnormalities (ARIA) when treated with anti-amyloid monoclonal antibodies.

In a prospective multicenter study with 607 participants with cognitive complaints or objective memory impairment, the test showed 100 percent agreement with the genetic determination of APOE4 by Sanger sequencing.

The Elecsys ApoE4 test complements other Roche biomarkers such as the recently CE-marked Elecsys pTau181 test for the evaluation of Alzheimer’s-associated proteins. Both use a single blood sample and can be used on widely used Roche instruments, enabling wide availability in CE markets.

The approval underlines Roche’s commitment to Alzheimer’s diagnostics and therapy. Together with future biomarkers such as pTau217, it is expected to promote earlier and more accurate detection of the disease and pave the way for personalized treatments.

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