US National Institutes of Health

The goal of the Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) program is to support the evaluation of early-stage diagnostics and novel diagnostic strategies for TB to address an urgent need for improved diagnostics. TB is one of the leading infectious disease causes of mortality in the world. About 1.7 billion people are currently infected with Mycobacterium tuberculosis (Mtb) and are at risk of developing active TB disease. There are 10 million new TB cases and 1.5 million TB deaths annually. Increasing rates of multi-drug and extensively drug-resistant TB (MDR-TB and XDR-TB) pose a growing threat. Early diagnosis of TB and universal drug-susceptibility testing are critical to identifying the most appropriate treatment for individual patients and to preventing the spread of disease.

Main Area of Focus
Despite major advances in recent years, critical diagnostic needs are still needed for TB. There is an urgent need for true point of care (POC) diagnostics, including rapid drug susceptibility testing (DST), pediatric targeted diagnostics, assays that do not rely on sputum and technologies to improve diagnosis of disseminated and paucibacillary TB.

In 2020, NIAID made 3 awards to establish centers under the Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) solicitation (RFA-AI-19-030). These three centers will provide clinical site capacity to evaluate TB diagnostics in 12 TB-endemic countries and will evaluate 36 different assays and biomarkers, including diagnostics for triage testing, rapid point of care diagnosis and drug susceptibility testing. The centers have options for diagnostic technology holders to submit requests to have their early-stage TB diagnostic tests evaluated.

The centers will conduct proof-of principle studies and provide feedback to diagnostic developers on the performance of their technologies and potential strategies for use in endemic settings. These diagnostic technologies will be suitable for use in a variety of different settings and will include testing for different patient populations, such as pediatric groups and people living with HIV.