Professor Yasutoshi Kido of the Osaka Metropolitan University Graduate School of Medicine is collaborating with Danaform Inc. and the National Institute of Biomedical Research of the Democratic Republic of the Congo (INRB) to develop a portable rapid diagnostic system for Ebola virus disease (EVD) caused by Bundibugyo virus (BDBV). This project was selected for funding from the Global Health Innovative Technology Fund (GHIT Fund).
The World Health Organization (WHO) declared on May 16, 2026 (Geneva time, May 17 Japan time) a “Public Health Emergency of International Concern” (PHEIC) regarding the Ebola outbreak caused by BDBV in the Democratic Republic of the Congo and Uganda.
In affected areas, it is important to quickly test suspected cases to ensure patient isolation, contact tracing, and prompt treatment. In regions with limited medical resources, challenges remain in establishing point-of-care testing (POCT), which allows medical tests to be performed close to the point of patient care without the need for advanced testing facilities.
After the declaration of PHEIC, the research team worked quickly to establish a development framework. Using technology developed by DanaForm Co., Ltd. with support from the Defense Equipment Agency’s Security Technology Research Promotion Project, a prototype test kit for detecting BDBV was created in 40 days. Initial laboratory evaluation confirmed that the prototype met the target performance criteria.
The development schedule is in line with the goal of the 100-day mission, which aims to develop and deploy available diagnostics, therapeutics, and vaccines within 100 days of a new infectious disease threat being identified.
This project represents an example of a rapid research and development framework that leverages a collaborative network of industry, academia, government, and international partners.
Challenges in the diagnosis of Ebola virus disease caused by BDBV
BDBV is a member of the Ebolavirus genus and is distinct from Ebolavirus (EBOV, formerly Zaire Ebolavirus). Therefore, the knowledge gained from approved vaccines and diagnostic systems for EBOV cannot necessarily be directly applied to BDBV, and a testing system that can reliably detect and differentiate BDBV is required.
Current outbreak areas have constraints regarding specimen transportation, power supply, testing personnel, and biosafety. Sensitive and simple testing technologies that can be rapidly deployed near affected areas are critical for early diagnosis, isolation, contact tracing, and determining treatment strategies.
Development framework aligned with the “100-day mission” enables rapid response to outbreaks
The 100-day mission is an international goal that aims to ensure diagnostic tests, treatments, vaccines and other tools are available within 100 days of an emerging infectious disease outbreak.
As part of this effort, OMU researchers are building a rapid response development framework that integrates OMU’s international research hubs and international network, KK Danaform’s portable nucleic acid testing platform development technology, and INRB’s field-based outbreak investigation capabilities and research infrastructure. The Japanese government is also contributing to the construction of this framework as part of its Global Health Strategy*.
The team began development work immediately after the declaration of PHEIC and achieved early development milestones consistent with the objectives of the 100-day mission.
GenPad Smart BDBV Portable Rapid Diagnostic System Features
This system utilizes Danaform Inc.’s “GenPad” POCT platform based on SmartAmp isothermal PCR technology (Eprobe detection). The platform is designed for portable equipment that can be used in outbreak sites without electrical power infrastructure.
The prototype is being developed with the following functionality in mind:
- In initial laboratory testing, the prototype met the LOD target of less than 200 copies per cartridge, consistent with performance criteria referenced in WHO EUL documentation.
- Initial clinical testing showed no cross-reactivity against a panel of 86 microorganisms
- Portable (weighs only 460 g)
- Battery powered (7.2 VDC, 21.6 Wh) to run 8 tests on a single charge
- Results are available in about 30 minutes after blood collection
- It uses a fully sealed cartridge and is designed to simplify sample handling and reduce exposure risk after proper training.
- Multiple devices can be clustered to support simultaneous testing of multiple samples.
How to use GenPad Smart BDBV
A video introducing the platform in the development stage is available at https://www.dnaform.jp/ja/GenPad/Product/BDBV.
*This is an introduction video of the GenPad cartridge developed for detecting Ebola hemorrhagic fever (Bundibugyo virus). This product is currently under development and evaluation and is not intended for clinical use or commercial sale.
Research background
Since 2020, OMU has been supported by the Japan Agency for Medical Research and Development (AMED)’s “Translational Effectiveness Research Center in the Democratic Republic of the Congo” project. Through this initiative, OMU and INRB established a long-term collaborative research framework and established an overseas research center in the Democratic Republic of the Congo. The center has not only strengthened research infrastructure but also contributed to capacity building through joint training of researchers and students from both institutions.
This research also extends to mpox declared PHEIC in 2022 and 2024. OMU is collaborating with INRB to advance research into emerging infectious diseases through initiatives such as AMED’s “Elucidating human immunity for orthopoxvirus prevention through serological epidemiology” project.
OMU and DanaForm, Inc. have been conducting research and development of a portable nucleic acid testing platform since 2025 with support from AMED’s “Development of Mpox Point-of-Care Testing System Utilizing Portable, High Sensitivity, and Simple PCR Technology” project. Building this trust and improving our established development infrastructure has made this rapid development possible.
With support from the Defense Equipment Agency’s Security Technology Research Promotion Project, DanaForm Co., Ltd. has established a system to develop, manufacture, and ship GenPad cartridges that can detect unknown pathogens within 40 days of the outbreak of an unknown new infectious disease. This system serves as the foundation for your program and allows you to quickly develop products as needed. This statement does not imply that ATLA guarantees the product’s performance, clinical use, or regulatory approval.
Future plans
Our research team will proceed with verification and development in stages.
- Performance validation using mock samples (non-replicating, non-infectious virus mimics known as armored RNA)
- Clinical performance validation using clinical samples in the Democratic Republic of the Congo in collaboration with INRB
- The development of a BDBV-specific test kit remains a priority, although the development of a multiplex version that can distinguish between BDBV, EBOV, and SUDV within a single cartridge is also underway.
- Preparing data needed for potential WHO Emergency Use Listing and other emergency regulatory pathways
Through these two parallel development strategies, the team aims to establish both a BDBV-specific test that meets current emergency needs and a versatile testing platform that can respond to future EVD outbreaks. This strategy is being implemented in close collaboration with international organizations, including the WHO.
This project was selected by the Global Health Innovation Technology Fund (GHIT Fund). GHIT Fund support is for approved initial development milestones, such as prototype development and performance validation. This project is part of OMU’s ongoing efforts to foster research and technology development to combat infectious diseases through collaboration with industry, academia, government, and international organizations.
sauce:
Osaka Metropolitan University
