Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (R01 Clinical Trial Not Allowed)

Background
The purpose of this notice of funding opportunity (NOFO) is to support the evaluation of early-stage diagnostics and novel diagnostic strategies for Tuberculosis (TB) in the context of existing clinical algorithms in TB endemic countries. The World Health Organization (WHO) estimates that 10.6 million people became ill with TB and 1.3 million died of TB disease in 2022. There is a large global gap between the estimated number of people who fell ill with TB and the number of people newly diagnosed, with approximately 3.1 million people not diagnosed with the disease, or not officially reported to national authorities in 2022.
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 (DST) are critical to identifying the most appropriate treatment for individual patients and to preventing the spread of disease.

Grant Details
The purpose of this NOFO is to support proof-of principle studies to evaluate novel, early-stage TB diagnostic tests assays and strategies, validate biomarkers, and provide feedback to diagnostic developers and policy makers on the performance of the technology and potential strategies for use in endemic settings. Funding under this NOFO will establish a partnership of investigators and existing clinical study sites in TB endemic countries, coordinated and led by a leadership team.
Clinical sites are encouraged to provide access to both adult and pediatric study populations with drug susceptible and drug resistant TB, including HIV-negative and PLWH.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), U.S. Territory or Possession, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (Foreign Organizations), foreign components of U.S. Organizations.

Period of Performance
The project period must be 5 years.

Grant Value
NIAID intends to commit $5,500,000 in FY 2025 to fund 1-2 awards. Application budgets are not limited but are not expected to exceed $3,500,000 in direct costs per year.

Place of Performance
The specific geographic location(s) where the grant will be performed are TB endemic countries.