Roche has announced that it has received the CE mark for its Elecsys® Dengue Ag test, a high-throughput, fully automated immunoassay designed to aid in the early diagnosis of acute dengue virus infection. This marks a significant milestone in improving diagnostic efficiency and reliability against one of the fastest-spreading viral diseases worldwide.
Dengue fever remains the most prevalent mosquito-borne viral illness globally, with a record surge in 2024 that affected over 100 countries across all continents. The year saw more than 14.6 million reported cases and over 12,000 dengue-related deaths, the highest ever recorded within a 12-month period. The disease’s continued expansion over the past five decades has made it a major global health concern, with half of the world’s population now living in dengue-endemic regions.
Because dengue symptoms closely resemble those of other febrile illnesses such as chikungunya or yellow fever, accurate laboratory testing plays a crucial role in differentiating infections and ensuring timely medical management to prevent severe complications.
“Dengue’s rapid worldwide spread has elevated it to a serious global burden, placing a significant strain on healthcare resources,” said Matt Sause, CEO of Roche Diagnostics. “Roche is committed to supporting the global response to the rise of infectious diseases such as dengue. With our novel Elecsys Dengue antigen test, we enable healthcare systems to diagnose dengue more reliably and efficiently.”
The Elecsys® Dengue Ag test detects the NS1 antigen, a biomarker that appears early in the course of infection, allowing healthcare providers to diagnose dengue during the critical initial phase when clinical symptoms are often non-specific.
Acknowledging the central role of diagnostics in public health, the World Health Organization (WHO) includes dengue virus NS1 antigen testing in its Essential Diagnostics List, which identifies key in-vitro diagnostic tools that should be accessible to all nations to enable timely and life-saving diagnoses.
With this CE mark approval, Roche’s innovation is expected to strengthen global diagnostic capabilities, supporting healthcare systems in managing outbreaks more effectively and reducing the overall disease burden.
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