Roche receives CE Mark for Elecsys Apolipoprotein E4 test

Roche (RHHBY) announced that it has received CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test – the first in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream. The ApoE4 gene variant is associated with an increased risk of late-onset Alzheimer’s disease, and is present in approximately 40-60% of Alzheimer’s patients. Alzheimer’s disease accounts for up to 70% of dementia cases worldwide2 and is predicted to affect almost 150 million people by 2050. “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.”