The Global Health Innovative Technology (GHIT) Fund has awarded a $4.5m grant to US-based diagnostic developer Fluxus, a Fujirebio subsidiary, to develop an ultrasensitive point-of-care (POC) urine test for tuberculosis (TB).

According to GHIT, existing TB tests struggle with issues such as low sensitivity and the need for specialised equipment.

To address these challenges, GHIT committed to this investment in a new TB diagnostic development project, which involves Fluxus, Fujirebio, and Germany’s Heidelberg University Hospital.

In this project, Fluxus' ultrasensitive detection technology will be utilised for developing and validating the urine-based TB biomarker lipoarabinomannan (LAM) assay.

The project will also develop crucial components required for the POC system, which is said to integrate the LAM test.

The technology is designed to facilitate swift and accessible diagnostics that can benefit a larger group of patients.

The POC test will measure the TB biomarker LAM in urine, with Fluxus already having a prototype ultrasensitive LAM assay on its benchtop analyser platform.

It will leverage Fluxus’ technology, with the likelihood of usage in pulmonary and extrapulmonary TB in all individuals.

The GHIT award will support the development and launch of the POC instrument, with work being conducted in collaboration with the Rapid Research in Diagnostics Development (R2D2) for TB Network, Stanford University and Health Care.

The GHIT Fund collaborates with global partners to mobilise Japanese industry and research in creating new solutions for neglected diseases.

This investment in TB diagnostics aligns with GHIT's broader mission to address diseases affecting vulnerable populations.

Last December, Fujirebio and Eisai signed a memorandum of understanding for joint research on neurodegenerative disease biomarkers.