NEW YORK – Revvity said Wednesday that it has received CE marking for a blood-based molecular assay that is used to help assess a patient's risk of side effects to anti-amyloid (beta) therapy for Alzheimer's disease.
The firm's Euroimmun subsidiary received CE marking on Sept. 30 for its EuroRealTime APOE assay, and Revvity announced this week the launch of that test in European countries that accept the CE mark. The PCR assay is used for the simultaneous detection of the three most common forms of the APOE gene, dubbed E2, E3, and E4.
The carriers of the E4 gene have the highest risk for life-threatening edema or micro-bleeding in the brain as side effects of anti-amyloid (beta) therapies.
"Being able to easily determine the APOE genotype of patients before starting therapy is key to assessing the individual risk for potential negative consequences," Euroimmun CSO Lars Komorowski said in a statement.
The firm said that the assay is compatible with the automated processing on Revvity instruments including the Euroimmun PreNAT II and Chemagic 360 systems. The company's EuroRealTime analysis software is used for the evaluation, documentation, and archiving of test results.