Roche secures CE mark for its new Elecsys Dengue Ag high‑throughput test

Roche has received CE marking for its new Elecsys Dengue Ag test—a fully automated, high‑throughput immunoassay designed to help diagnose acute dengue virus infections. The test identifies the NS1 antigen of the dengue virus across all four known serotypes (DENV‑1 through DENV‑4) with a clinical sensitivity of 94.90 % and specificity of 99.96 %. Operating on Roche’s cobas® e analyser platforms, the assay delivers results in approximately 18 minutes and supports throughput of up to 300 tests per hour, allowing labs to respond more swiftly during dengue outbreaks. With dengue fever now spreading rapidly—affecting over 14.6 million people and causing more than 12,000 deaths in 2024—early and accurate detection has become more important than ever. Roche says the Elecsys Dengue Ag test marks a key milestone in enabling healthcare systems to improve diagnostic reliability and efficiency when managing dengue world‑wide. “Dengue’s rapid worldwide spread has elevated it to a serious global burden,” said Roche Diagnostics CEO Matt Sause. He added that Roche remains committed to strengthening global responses to infectious diseases like dengue. #DengueDiagnostics #RocheHealthcare #GlobalHealth #InfectiousDiseaseInnovation #SlimScan #GrowthStocks #CANSLIM