India Pharma Outlook Team | Thursday, 30 October 2025
Roche today announced that it has been awarded CE mark for its Elecsys Dengue Ag test, a high-throughput, completely automated immunoassay intended to support the diagnosis of acute dengue virus infection.
This achievement represents a significant advance in countering the growing worldwide threat of dengue fever, a mosquito-borne disease that keeps spreading across the globe.
Dengue in 2024 hit record highs at more than 14.6 million cases and over 12,000 fatalities in 100 countries. Because symptoms tend to mirror other viral infections, early and correct testing is important in order to avoid serious complications.
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Roche's new Elecsys Dengue Ag test aids in the detection of the NS1 antigen, a primary marker of early infection, and provides results in as short a time as 18 minutes on Roche's cobas e immunoassay analyzers, which have the capacity to analyze up to 300 tests per hour.
The test proved 94.9% sensitive and 99.96% specific, picking up all four serotypes of the dengue virus—DENV-1, DENV-2, DENV-3, and DENV-4. It is also the component of the overall Elecsys Dengue Panel, which in the near future will include IgM and IgG tests to cover all phases of infection.
The launch supports Roche's mission to address infectious diseases with diagnostic solutions through innovation, according to the CEO of Roche Diagnostics, Matt Sause. The company's innovation is in line with the World Health Organization's Essential Diagnostics List, stressing the value of available and reliable tests in worldwide health systems.
As dengue cases rise with the effects of climate change and expanding ranges of mosquitoes, Roche's new diagnostic innovation comes at the right time for healthcare professionals globally.
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