Investment of Approx. USD 4.5 Million in Development of Diagnostics for Tuberculosis to Partners Including Fujirebio and University Hospital Heidelberg

This project will leverage Fluxus' cutting-edge ultrasensitive detection technology to develop and validate a urine-based TB biomarker lipoarabinomannan (LAM) assay on its automated benchtop immunoassay analyzer. Additionally, the project will design and develop critical components for a portable, ultrasensitive point-of-care (PoC) system that integrates the urine LAM test. This advanced technology will enable rapid, accurate, and accessible diagnosis across a broader patient population, contributing to improved clinical outcomes and reduced transmission.

In addition, the GHIT Fund will invest approximately JPY 15.9 million (USD 0.1 million¹) in a screening project against Chagas disease and leishmaniasis by Kitasato University, Nagasaki University, University of Tokyo, and Drugs for Neglected Diseases initiative (DNDi).

Please refer to Appendix 1 for detailed descriptions on these projects and their development stages.

As of March 31, 2025, the GHIT Fund has invested in 36 projects, including 15 discovery projects, 12 preclinical projects, and 9 clinical trials.⁵ The total amount of investments since 2013 is JPY 38.2 billion (USD 255 million¹) (Appendix 2).

¹USD1 = JPY149.53, the approximate exchange rate on March 31, 2025.
² These awarded projects were selected and approved as new investments from among proposals to RFP2023-002 and RFP2024-001 for the Product Development Platform and the Screening Platform, which were open for applications from June 2023 to July 2024.
³ WHO: https://www.who.int/news-room/fact-sheets/detail/tuberculosis
⁴ Fluxus, Inc. and Fujirebio, Inc. are members of Fujirebio.
⁵ This number includes projects in the registration phase.

The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases.
https://www.ghitfund.org/en

Appendix 1. Project Details

ID: G2023-204

3. Heidelberg University Hospital (Germany)

[Project design]
The project objectives will be achieved by performing the following Specific Aims: 1)
Complete development and validation of an ultrasensitive urine LAM assay on an
existing benchtop immunoassay analyzer. This essay will be adapted and transferred to a
stable and cost-effective PoC cartridge format. 2) Design and development of critical
components for a portable, ultrasensitive PoC system, with functional cartridge and prototype PoC LAM assay.

ID: S2024-122

3. University of Tokyo (Japan)

4. Drugs for Neglected Diseases initiative (DNDi) (Switzerland)

[Project design]
In this project, three academic institutions (Kitasato University, Nagasaki University, and
the University of Tokyo) and DNDi will utilize their expertise to identify at least five
seed compounds for Chagas disease therapeutics produced by microorganisms in a one-
and-a-half-year research period. The seed compounds for Chagas disease therapeutics to
be identified during the project will also be assessed for their activity against Leishmania
donovani, which causes visceral leishmaniasis, to verify their drug potential.

*All amounts are listed at an exchange rate of USD1 = JPY149.53, the approximate exchange rate on March 31, 2025.

Appendix 2. Investment Overview (as of March 31, 2025)

Investments to date
Total investments: 38.2 billion yen (USD 255 million¹)
Total invested projects: 136 (36 active projects and 100 completed projects)

To learn more about the GHIT Fund's investments, please visit
Investment Overview: https://www.ghitfund.org/investment/overview/en
Portfolio: https://www.ghitfund.org/investment/portfolio/en
Advancing Portfolio: https://www.ghitfund.org/investment/advancingportfolio/en
Clinical Candidates: https://www.ghitfund.org/investment/clinicalcandidates/en 

For more information, contact:
Katy Lenard at +1-301-280-5719 or klenard@burness.com
Mina Ohata at +81-36441-2032 or mina.ohata@ghitfund.org

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