Tuberculosis (TB) kills more people than any other single infectious disease, including HIV. Low- and middle-income countries overwhelmingly bear the highest burden, and the impact of the disease on individuals and communities is devastating. Every year, millions of TB infections go unidentified, preventing patients from accessing treatment, and allowing the disease to spread. Drug resistance is a growing threat.
Diagnostics are needed to detect exposure, diagnose disease and drug resistance, and monitor improvement under treatment in both primary healthcare and laboratory settings.
High accuracy, short time to obtain a result, and simple use at an affordable price can be significant challenges for current TB diagnostic tools. It takes weeks to grow bacteria for a culture test, the current best test for TB. Sputum smear microscopy is currently most widely used first test for diagnosis: it is inexpensive and widely available but not very accurate – and children and HIV+ people often cannot produce a sputum sample.
The development of a molecular test that can provide an accurate result for diagnosis and drug resistance in less than 2 hours has been a great step forward, but it requires infrastructure and is often not affordable in many low-resource settings.
Ensuring that the right tools are accessible where they are needed is not straightforward, and development of any new diagnostic test has to take into account the context in which it would be used.
There is a lot to do. But despite the global target to end this epidemic by 2030, TB remains woefully underfunded, putting at risk diagnostic innovation that is critical to achieving this ambition.
We are working with our partners and donors to make easy-to-use, robust, reliable and highly accurate tests a reality in routine clinical settings, particularly at the lower levels of care. Our R&D efforts are focused on areas of critical unmet need.
- A user-friendly, low-cost, non-sputum-based rapid test for diagnosing active TB that can be used for active case-finding and in primary healthcare facilities.
- Rapid drug-resistance tests that enable treatment regimens to be tailored to individuals and help to safeguard medicines against AMR.
In parallel, we are developing strategies to increase and speed up access to both new and existing tools. This includes supporting the evaluation of new tests so that WHO and other regulatory bodies can make recommendations and decide how new approaches should be incorporated into guidelines, as well as working with countries to define local implementation needs, including NGS.
We are also exploring digital technologies to enhance diagnostic connectivity and data utilization for optimal health impact.
TB R&D pipeline
|Catalyse Development||Guide Use and Policy|
|TB host & pathogen marker screening||LAM sputum monitoring (Otsuka)||LAM RDTs for HIV+ (Fujifilm)||Truenat (Molbio)|
|LAM RDTs for broad use cases||Triage POC test (TBD)||Decentralized use: Xpert XDR (Cepheid)||Centralized DST (Roche, Abbott, BD, Hain)|
|Centralized use: Next Generation Sequencing||Centralized use: Flurotype XDR (Hain)||Host biomarker and phenotypic ID tool landscaping|
|POC molecular ID & DST (Blink Dx)||GeneXpert Omni (Cepheid)||Paediatric TB stool kit (Rutgers)|
|Radiology: CAD4TB (Delft), Qure.ai|
|Breath test /Enose, RBS)|
Download our full R&D pipeline.