March 20, 2026
Tuberculosis (TB) remains one of the world’s most persistent public health challenges and one of its deadliest infectious diseases. In 2023, an estimated 10.8 million people fell ill with TB, and about 1.25 million died, according to the World Health Organization.
Early diagnosis and treatment are critical to managing TB and preventing its spread, but many current diagnostic tools can be slow, costly, and dependent on specialized facilities. These constraints can limit access and delay care, particularly in rural and underserved communities.
To help address this challenge, Noze, in collaboration with HJFMRI researchers at the KEMRI Clinical Research Center in Kericho, Kenya, has sponsored a first-in-human proof-of-concept study evaluating its innovative breath-based diagnostic platform for TB. The investigational device, DiagNoze®, combines advanced odor-detection technology with artificial intelligence to analyze biomarkers in exhaled breath that may indicate TB.
Funded by the Gates Foundation, the study has enrolled 200 adults living with and without TB. Participants each provided up to five breath samples using the DiagNoze® device, alongside demographic and clinical data. Comparator samples including blood, urine, and respiratory specimens were collected for established TB and HIV testing, enabling head-to-head benchmarking of DiagNoze® against reference methods. Enrollment began in May 2025 and was completed in November 2025. Data analysis is currently underway.
Findings from this study will inform the next phase of development of this novel diagnostic device, which has the potential to transform TB detection by offering a rapid, portable, non-invasive, and cost-effective tool for communities where healthcare resources are limited and TB prevalence remains high.