Professor Yasutoshi Kido of the Graduate School of Medicine, Osaka Metropolitan University (OMU), in collaboration with K.K. DNAFORM and the National Institute for Biomedical Research (INRB) of the Democratic Republic of the Congo, is developing a portable rapid diagnostic system for Ebola virus disease (EVD) caused by Bundibugyo virus (BDBV). The project has been selected for funding by the Global Health Innovative Technology Fund (GHIT Fund).
On May 16, 2026 (Geneva time; May 17, Japan time), the World Health Organization (WHO) declared a "Public Health Emergency of International Concern" (PHEIC) regarding the outbreak of Ebola virus disease caused by BDBV in the Democratic Republic of the Congo and Uganda.
In affected areas, it is crucial to rapidly test suspected cases and ensure patient isolation, contact tracing, and prompt treatment. In regions with limited medical resources, challenges remain in establishing point-of-care testing (POCT), which enables medical testing to be performed near the site of patient care without advanced laboratory facilities.
The research team worked quickly to establish a development framework following the declaration of a PHEIC. Utilizing technology that is being developed by K.K. DNAFORM with support from the Acquisition, Technology & Logistics Agency's Security Technology Research Promotion Program, the team produced a prototype test kit for detecting BDBV in 40 days. Initial laboratory evaluation confirmed that the prototype met the target performance criteria.
The development timeline is aligned with the objective of "100-Day Mission", which aims to develop and deploy diagnostics, therapeutics, and vaccines available within 100 days of identifying a new infectious disease threat.
The project represents a practical example of a rapid research and development framework that leverages a collaborative network of industry, academia, government, and international partners.
Challenges in diagnosing Ebola virus disease caused by BDBV
BDBV is a member of the genus Ebolavirus and is distinct from Ebola virus (EBOV, formerly Zaire ebolavirus). Therefore, knowledge generated from approved vaccines and diagnostic systems targeting EBOV cannot necessarily be applied directly to BDBV, and testing systems that can reliably detect and differentiate BDBV are needed.
In current outbreak areas, there are constraints regarding specimen transport, power supply, testing personnel, and biosafety. Highly sensitive and simple testing technologies that can be rapidly deployed near affected areas are important for early diagnosis, isolation, contact tracing, and determining treatment strategies.
Development framework aligned with the "100-day mission" allows a rapid response to outbreaks
The "100-Day Mission" is an international goal aimed at ensuring diagnostic tests, treatments, vaccines, and other tools are ready to use within 100 days of the confirmation of an emerging infectious disease outbreak.
As part of this initiative, OMU researchers are building a rapid-response development framework that integrates OMU's overseas research base and international network, with K.K. DNAFORM's technology for developing portable nucleic acid testing platforms and INRB's field-based outbreak investigation capacity and research infrastructure. The Japanese government is also contributing to the establishment of this framework as part of its Global Health Strategy*.
The team launched its development efforts immediately after the declaration of a PHEIC and achieved early development milestones aligned with the objectives of the 100-Day Mission.
Features of the GenPad smart BDBV portable rapid diagnostic system
This system utilizes the "GenPad" POCT platform, which is based on K.K. DNAFORM's SmartAmp isothermal PCR technology (Eprobe detection). The platform is designed to use portable equipment that can be used even at outbreak sites without power infrastructure.
The prototype is being developed with the following intended features:
- In initial laboratory testing, the prototype met the LOD target of ≤200 copies per cartridge, consistent with performance criteria referenced in WHO EUL-related materials.
- In initial laboratory testing, no cross-reactivity was observed against a panel of 86 microbial species
- Portable (weighing only 460 g)
- Battery-powered (7.2 VDC, 21.6 Wh) and capable of performing eight tests on a single charge
- Results available in approximately 30 minutes from blood collection
- Uses fully sealed cartridges, designed to simplify sample handling and reduce exposure risk after appropriate training
- Multiple devices can be clustered together to support simultaneous testing of multiple samples
How to use the GenPad smart BDBV
A video introducing the development-stage platform is available at https://www.dnaform.jp/ja/GenPad/Product/BDBV
*This is an introductory video for the GenPad cartridge being developed for the detection of Ebola virus disease (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 received support from the Japan Agency for Medical Research and Development's (AMED's) "Center for Translational and Effectiveness Research in Democratic Republic of the Congo" project. Through this initiative, OMU and INRB have built a long-term collaborative research framework and established an overseas research center in the DRC. This center has not only strengthened research infrastructure, but has also contributed to capacity building through joint training of researchers and students from both institutions.
The research also extends to mpox, which was declared a PHEIC in 2022 and 2024. OMU has been advancing research on emerging infectious diseases in collaboration with the INRB through initiatives such as the AMED "Unraveling Human Immunity for Orthopoxvirus Prevention via Serological Epidemiology" project.
Since 2025, OMU and K.K. DNAFORM have been researching the development of portable nucleic acid testing platforms with support from AMED's "Development of point of care testing system for Mpox based on a portable, highly sensitive and simple PCR technique" project. Building these trusted relationships and improving the established development infrastructure have made this rapid development possible.
With support from the Acquisition, Technology & Logistics Agency's Security Technology Research Promotion Program, K.K. DNAFORM has established a system to develop, manufacture, and ship GenPad cartridges capable of detecting unknown pathogens within 40 days of the emergence of a new, unknown infectious disease. This system serves as the foundation of the program, enabling the rapid development of the product 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 validation and development in phases:
- Performance validation using mock samples (virus mimics that do not replicate and are non-infectious, known as armored RNA)
- Clinical performance validation using clinical samples in the Democratic Republic of the Congo, in collaboration with INRB
- Parallel development of a multiplex version capable of differentiating BDBV, EBOV, and SUDV within a single cartridge is underway, although the development of a BDBV-specific test kit remains the priority
- Preparation of data required for potential WHO Emergency Use Listing and other emergency regulatory pathways
Through this two-track parallel development strategy, the team aims to establish both a BDBV-specific test to meet current urgent needs and a highly versatile testing platform capable of responding to future Ebola virus disease outbreaks. This strategy is being executed in close coordination with international organizations including the WHO.
This project has been selected by the Global Health Innovative Technology Fund (GHIT Fund). GHIT Fund's support covers approved early development milestones, including prototype development and performance validation. The project is part of OMU's continued commitment to promoting research and the development of technologies for combating infectious diseases through collaborations with industry, academia, government, and international organizations.
Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI