Introduction and Background of the Project

1. Introduction
Ebola virus disease (EVD) caused by Bundibugyo virus (BDBV), for which WHO declared a Public Health Emergency of International Concern (PHEIC) on 17 May 2026, has highlighted the urgent need to develop rapid diagnostics, as existing EVD tests may not detect BDBV. Laboratory-based diagnosis remains essential for confirming EVD; however, in outbreak settings with limited healthcare resources, it is often difficult to obtain rapid results close to patients. In this project, we will develop and evaluate a point-of-care (POC) testing system for EVD using GenPad, a portable isothermal nucleic acid amplification platform developed by K.K. DNAFORM. By combining Osaka Metropolitan University’s global research network, DNAFORM’s GenPad technology, and Institut National de Recherche Biomédicale (INRB)s infrastructure for responding to emerging infectious diseases, the project aims to contribute to both the current BDBV outbreak response and future preparedness for Ebola virus disease.

2. Project Objective
This project aims to develop two EVD diagnostic cartridges based on the GenPad platform and to evaluate their clinical performance. In response to the current PHEIC, development will first prioritize a BDBV-specific cartridge. The project will subsequently develop a multiplex cartridge capable of detecting and differentiating BDBV, Ebola virus (EBOV), and Sudan virus (SUDV) in a single test. Both tracks share the same GenPad platform and primer/probe design framework. At the laboratory level, the system has met the WHO Emergency Use Listing (EUL) performance target for limit of detection of 200 copies per test or lower. Based on the data generated, the project will prepare technical documentation for WHO EUL and support future field deployment after completion of the necessary regulatory and public health procedures.

3. Project Design
This project will develop two test kits in parallel. While priority will be given to the BDBV single-target test kit, a multiplex version capable of differentiating BDBV, EBOV, and SUDV in a single cartridge will also be developed in parallel. The development process includes: (1) reagent design, prototype manufacturing, and laboratory evaluation using the genome sequence of the BDBV outbreak strain; and (2) performance verification using contrived specimens and clinical specimens. Through this two-track parallel development strategy, the project aims to respond to the immediate need for BDBV-specific testing while also building a versatile testing platform that may be applicable to future Ebola virus disease outbreaks. The consortium will also work in close coordination with WHO and other international organizations.

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

EVD outbreaks have a major impact on communities in sub-Saharan Africa where medical and laboratory infrastructure is limited. Diagnostic delays can prolong outbreaks, increase mortality, and delay contact tracing and infection control measures. This project addresses these challenges by developing a portable POC testing system that can be used in hospitals, health centers, and community-level outbreak response settings while maintaining a level of accuracy comparable to conventional advanced laboratory testing. The cartridge is designed for use with small-volume whole-blood specimens, to provide results in approximately 30 minutes, and to achieve sensitivity comparable to PCR. Such testing can support early triage, isolation decisions, contact tracing, and surveillance in outbreak-affected areas.

What sort of innovation are you bringing in your project?

The innovation of this project lies in bringing high-sensitivity molecular diagnosis of Ebola virus disease closer to rapid use in outbreak settings, rather than limiting it to laboratory-centered testing. GenPad Smart BDBV uses the GenPad POCT platform based on DNAFORM’s proprietary SmartAmp isothermal PCR technology with Eprobe detection. It is designed for use in outbreak areas where electricity and laboratory facilities may be limited, using a portable device and a fully enclosed cartridge that does not require large instruments. The device is portable (460 g), battery-powered, and designed to be operated without special training. Another important innovation is the development framework itself: after the PHEIC declaration, the consortium set milestones aligned with the 100 Days Mission and is rapidly advancing through design, prototyping, performance evaluation, and clinical evaluation within a short period of time.

Role and Responsibility of Each Partner

Osaka Metropolitan University (OMU) 
OMU is responsible for development strategy planning and performance evaluation using contrived specimens, and provides scientific leadership and overall project management. OMU also leads regulatory strategy development and coordination with relevant organizations.

K.K. DNAFORM 
DNAFORM is responsible for the design, manufacturing, and optimization of the GenPad cartridge. This includes primer design, integration into the cartridge, optimization of reaction conditions, reagent formulation, and manufacturing under an ISO 13485-certified quality management system.

Institut National de Recherche Biomédicale (INRB)
INRB is responsible for clinical evaluation in the Democratic Republic of the Congo. INRB will provide access to specimens from confirmed EVD patients and symptomatic controls in the ongoing BDBV outbreak and conduct comparative testing against a reference PCR method. INRB will also support communication and coordination with domestic and international public health stakeholders and help facilitate effective field use of the testing system.

Others (including references if necessary)

The following references provide background information on the 2026 Bundibugyo virus disease outbreak and the international preparedness context relevant to this project.

1. World Health Organization. Epidemic of Ebola Disease caused by Bundibugyo virus in the Democratic Republic of the Congo and Uganda determined a Public Health Emergency of International Concern. WHO statement. 17 May 2026.
https://www.who.int/news/item/17-05-2026-epidemic-of-ebola-disease-in-the-democratic-republic-of-the-congo-and-uganda-determined-a-public-health-emergency-of-international-concern

2. International Pandemic Preparedness Secretariat. Ebola Bundibugyo (BDBV) outbreak 2026. 2026.
https://ippsecretariat.org/news/category/ebola-bdbv/