Roche Holding AG (RHHBY) said on Monday it has received CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test- the first in-vitro diagnostic (IVD) 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 around 40-60% of patients with the condition.
The clinical performance of the assay was evaluated in participants with cognitive complaints or objective memory impairment of unknown cause. Results from the Elecsys ApoE4 test were compared with APOE4 genotyping performed using Sanger sequencing. The assay showed 100% concordance between ApoE4 protein detection and genetic APOE4 status, correctly identifying all genetic carriers and non-carriers.
For comments and feedback contact: editorial@rttnews.com
Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.