Introduction and Background of the Project

Introduction
Dengue and chikungunya are viral diseases transmitted primarily by mosquitoes such as Aedes aegypti and Aedes albopictus. Driven by climate change, urbanization, and increased international travel, these diseases are expanding across tropical and subtropical regions, particularly in Asia, Latin America, and Africa. Dengue is one of the most prevalent mosquito-borne diseases worldwide, with an estimated hundreds of millions of infections annually, representing a substantial public health burden.
Dengue virus consists of four distinct serotypes. While infection with one serotype confers long-term immunity against that specific serotype, subsequent infection with a different serotype is known to increase the risk of severe disease. As a result, understanding the distribution and dynamics of circulating serotypes in endemic regions is critical for patient management and outbreak control. In contrast, chikungunya infection may lead not only to acute symptoms but also to chronic joint pain following infection, which can have long-term impacts on patients’ quality of life and social reintegration. However, dengue and chikungunya present with similar early clinical symptoms, making rapid differentiation and identification at the point of care challenge.
Against this backdrop, there is a growing need for diagnostic technologies that can rapidly and accurately differentiate and identify these diseases in frontline healthcare settings. VisGene Ltd. is a Japan-based biotechnology company dedicated to developing rapid and practical diagnostic solutions for infectious diseases that impose a particularly high disease burden in low- and middle-income countries. Building on collaborative research with institutions in Japan, Thailand, and Peru, this project aims to translate these efforts into diagnostic products that support early diagnosis and effective public health responses in endemic settings.

Project Objective
The objective of this project is to develop and validate a rapid antigen test capable of simultaneously detecting and differentiating dengue virus serotypes 1–4 and chikungunya virus directly from whole blood within 15 minutes. Differences among dengue virus serotypes are known to influence clinical outcomes and the risk of severe disease. This test is intended to support early diagnosis, appropriate patient management, and effective outbreak response.

Project Design
The project integrates serotype-specific detection technology targeting the dengue virus NS1 antigen with monoclonal antibodies against the chikungunya virus E1 antigen into a rapid immunochromatographic device. Clinical evaluations will be conducted in Thailand and Peru, followed by regulatory submissions and development activities with the aim of supporting future regulatory approval and potential WHO prequalification.

How can your partnership (project) address global health challenges?

Dengue and Chikungunya frequently co-circulate in endemic regions, where rapid differential diagnosis represents a major public health challenge. This test will improve diagnostic accuracy at both healthcare facilities and the primary care level, contributing to the prevention of severe disease, earlier detection of outbreaks, and more timely public health responses at the community level.

What sort of innovation are you bringing in your project?

Building on serotype-specific dengue NS1 detection technology developed through collaboration between VisGene and The University of Osaka, this project aims to develop a novel rapid diagnostic test that combines dengue virus serotype identification with chikungunya virus detection. The test is designed to combine simplicity with high analytical performance, making it well suited for use in low- and middle-income country settings.

Role and Responsibility of Each Partner

VisGene Ltd. leads reagent design, manufacturing strategy, and regulatory coordination. Miyazaki University is responsible for technical and analytical validation and supports clinical study design. Mahidol University conducts clinical studies and regulatory activities in Thailand, while San Marcos University leads clinical evaluation in Peru.