TOKYO -- H.U. Group Holdings, Inc. and its wholly-owned subsidiary Fujirebio Holdings, Inc. announced that the Global Health Innovative Technology (GHIT) Fund has awarded a two-year, approximately $4.5 million grant to Fujirebio’s wholly-owned subsidiary, Fluxus, Inc. (Location: Sunnyvale, California), to develop an ultrasensitive point-of-care (POC) urine test for tuberculosis (TB). The test will utilize Fluxus’ novel single-molecule counting technology, with the potential to be used for both pulmonary and extrapulmonary TB in all patient populations.

According to the World health Organization (WHO)*1, up to two million people die from TB each year, making it one of the leading causes of infectious disease death worldwide. Diagnostic tests are typically performed in sputum, a sample type that is difficult to collect and which severely limits the types of TB and patient populations that can be tested. A sensitive, accurate, and accessible non-sputum-based test is urgently needed to reduce the global burden of TB.

The new POC test will measure lipoarabinomannan (LAM), a TB biomarker in urine. Fluxus currently has an ultrasensitive LAM assay prototyped on its benchtop analyzer platform*2. The GHIT award will fund development towards the launch of the POC instrument and adaptation of the LAM assay to POC test format. The work will be done by Fluxus in partnership with Rapid Research in Diagnostics Development (R2D2) for TB Network, as represented by Heidelberg University Hospital, and Stanford University and Health Care.

This grant enables Fujirebio to further contribute to addressing global health needs and delivering critical improvements in access to healthcare.

*1 WHO. Global Tuberculosis Report 2023, issued on November 7, 2023
*2 https://academic.oup.com/ofid/article/12/Supplement_1/ofae631.974/7987127#google_vignette