Roche Secures CE Mark For Elecsys® Dengue Ag Test, Strengthening Global Diagnostic Capabilities

Roche today announced that its Elecsys® Dengue Ag test has received the CE mark, authorizing its use across markets that recognize this certification. The fully automated, high-throughput immunoassay is designed to aid in the early diagnosis of acute dengue virus infections, addressing one of the fastest-growing global infectious diseases.

“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.”

Dengue remains the most prevalent mosquito-borne viral illness worldwide, with over 14.6 million cases and more than 12,000 deaths reported in 2024,  the highest annual toll ever recorded. The rapid spread of the virus, now affecting more than 100 countries, has made early and reliable diagnosis critical for patient management and outbreak control.

The Elecsys® Dengue Ag test detects NS1 antigen, a biomarker recognized by the World Health Organization (WHO) and featured in its Essential Diagnostics List, which emphasizes access to vital in-vitro diagnostic tools for all nations. Given that dengue symptoms often overlap with diseases like chikungunya and yellow fever, Roche’s new test offers clinicians a valuable tool for rapid, specific, and accurate diagnosis.

The launch underscores Roche’s continued investment in diagnostic innovation aimed at combating emerging and re-emerging infectious diseases through speed, precision, and scalability.