Development and performance evaluation of Iso-PAS technology for Mpox detection (Iso-PAS Mpox)

Project ID G2025-125 RFP Year 2025 Awarded Amount $712,796 Disease NTD(Others) Intervention Diagnostic Development Stage Technical Feasibility Collaboration Partners TBA Co., Ltd. , Japan Institute for Health Security (JIHS) , PATH , Institut National de Recherche Biomédicale (INRB) , NIPRO CORPORATION Disease NTD(Others) Intervention Diagnostic Development Stage Technical Feasibility Collaboration Partners TBA Co., Ltd. , Japan Institute for Health Security (JIHS) , PATH , Institut National de Recherche Biomédicale (INRB) , NIPRO CORPORATION Introduction and Background of the Project Introduction Mpox is an infectious disease caused by the monkeypox virus (MPXV), which develops symptoms such as fever, lymph node swelling, and rash. Since its discovery in 1970 in Zaire (the current Democratic Republish of the Congo) of the Central Africa, monkeypox infectious disease has been regarded as an endemic disease in Central and West Africa. However, with the increase in human mobility due to globalization, MPXV infection has been spreading rapidly, and WHO declared a public health emergency of international concern (PHEIC) in 2022 and 2024. MPXV is mainly classified into two strains (clades), Clade I and Clade II. As their infection rates and severity of the disease caused by them differ depending on the clade, a simple and convenient test kit that can distinguish between Clade I and Clade II is highly required. The Iso-PAS test method, whose platform technology was invented by TBA, is a combination of isothermal nucleic acid amplification and nucleic acid chromatography. This method enables genetic testing, which normally requires expensive measuring equipment, to be performed easily using conventional equipment. Project objective In this project, the team will develop a test kit that can distinguish between MPXV Clade I and Clade II using the Iso-PAS method, which is an inexpensive and simple genetic testing method. The project team's future aim is to register this test kit on the WHO Emergency Use Listing (EUL) following the accumulation of proven data from MPXV outbreak regions. Project design The following activities are to be implemented in the project: 1) Development of a prototype of Iso-PAS Mpox test kit, and its performance evaluation. 2) Performance study of the prototype using clinical specimens in the DRC. How can your partnership (project) address global health challenges? What this project proposes is the development of a simple Mpox test kit that can be used even in facilities in rural areas lacking adequate infrastructure. Mpox testing currently available is only provided at central laboratories in major cities. Consequently, in rural areas where there are many suspected cases, specimens must be transported to the laboratories in the major cities, leading to a problem of lengthy delays in diagnosis. This development enables Mpox testing to be conducted at facilities close to areas where suspected cases have occurred, facilitating prompt and appropriate treatment. What sort of innovation are you bringing in your project? This Iso-PAS technology enables highly sensitive genetic testing with equivalent convenience of operation to lateral flow assays, without requiring expensive testing equipment. It can not only detect MPXV but also distinguish its clade. Furthermore, this technology uses common cassettes and strips even when detecting different targets, enabling rapid adaptation to other diseases by simply redesigning primers and probes. Role and Responsibility of Each Partner - NIPRO CORPORATION: Manages the entire project as the designated development partner. Work on improving cassettes and reagents. - TBA Co., Ltd.: Develops and optimizes Mpox detection reagents and strips. Also responsible for manufacturing prototype kits. - Japan Institute for Health Security (JIHS): Plans and manages evaluation tests for prototypes in the DRC. - PATH: Provides technical advice on the development and improvement of prototypes. Supports the implementation of evaluation trials in the DRC. - Institut National de Recherche Biomédicale (INRB): Provides specimens for evaluation tests and conducts the tests in the DRC.