Roche has announced that it has received CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test.
The test is the first in vitro diagnostic (IVD) immunoassay to detect the ApoE4 gene variant in the bloodstream.
Why this matters
The ApoE4 gene variant is linked to a higher risk of late-onset Alzheimer's disease, found in 40-60% of affected individuals.
Alzheimer's accounts for nearly 70% of dementia cases globally and may impact almost 150 million people by 2050.
Previously, confirming ApoE4 carrier status required DNA testing. The Elecsys ApoE4 test now provides a fast, reliable alternative using a minimally invasive blood sample.
This enables healthcare providers to identify non-carriers and conserve genetic testing for those who need it most.
For identified carriers, follow-up genetic testing offers confirmation and detailed insights, which are important as current disease-modifying therapies (DMTs) depend on a patient's genetic profile.
"The approval of the Elecsys ApoE4 biomarker test is an important step forward in providing clinicians with a simple, accessible tool to identify genetic risk and guide Alzheimer's treatment decisions," said Matt Sause, CEO of Roche Diagnostics.
By helping clinicians quickly identify and triage ApoE4 carriers among patients with cognitive decline, the test simplifies the diagnostic process as well as patient management.
Roche also announced that the Elecsys ApoE4 test will complement its other blood-based biomarkers for Alzheimer's disease, including the recently CE-marked Elecsys pTau181 test, which assesses key proteins associated with the disease.
According to the company, these biomarkers "collectively provide valuable insights throughout the diagnostic journey," helping clinicians detect Alzheimer's disease earlier and make informed decisions about patient care following diagnosis.
The Elecsys ApoE4 test requires only a single blood sample, enabling seamless, efficient integration into the diagnostic process.
Additionally, widespread access to testing will be possible due to the large number of Roche instruments available in countries that accept the CE mark, providing a scalable plasma-based solution to support the Alzheimer's diagnostic pathway.