Technician in South Africa inserts cartridge containing a specimen into the Xpert machine for testing
Photo fromBull World Health Organ., 2013.

Xpert® MTB/RIF, is a fully automated molecular test to diagnose tuberculosis (TB), including its most resistant form, in less than 90 minutes and with minimal laboratory expertise.

Global Burden of Disease: ~10 million new cases of TB (2018)
Ideation to 50% Global Uptake: 8 years
Total Distribution: 11,282,500 in 125 Countries (2017)
Ideation to Proof of Concept
1 Year
Proof of Concept to 1st Country Launch
2 Years
1st Country Launch to Global Uptake 20%
4 Years
Global Uptake From 20% to 50%
1 Year

In 2004, in the attempt to improve TB diagnostics and bring diagnostics capabilities closer to the point-of-care, FIND facilitated a partnership between industry (Cepheid) and academia (UMDNJ/Rutgers) to develop a rapid diagnostic test for TB and rifampin-resistant TB (a good surrogate for multidrug-resistant TB). With the funding support of NIH and the Bill and Melinda Gates Foundation (BMGF) this partnership developed Xpert® MTB/RIF, an automated real-time PCR assay that runs on the multi-disease platform GeneXpert, and is performed directly on sputum, processed sputum sediment, and selected extrapulmonary specimens from adults and children. Xpert® MTB/RIF is a major improvement over earlier diagnostic options because it can simultaneously test for TB and drug-resistant TB in less than 2 hours, and requires minimal laboratory infrastructure and training.

The collaboration between both public and private partners has been key for the relatively quick pathway of development, political endorsements, price reductions, country roll-outs and scaling. 

Xpert® MTB/RIF has brought point-of-care diagnosis a step forward, although its reliance on sophisticated hardware (GeneXpert platform), uninterrupted power, and a consistent cold chain, are still obstacles to make it a real point-of-care diagnostic.