Funding to Evaluate Novel Diagnostics for Tuberculosis in Endemic Countries

NIAID aims to advance true point-of-care (POC) diagnostics for tuberculosis (TB)—including rapid drug-susceptibility testing (DST) in decentralized settings, targeted pediatric diagnostics that include non-sputum-based diagnosis, and technologies to improve the diagnosis of TB among people living with HIV (PLWH), including disseminated and paucibacillary TB.

Through Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (R01, Clinical Trial Not Allowed), we will 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 as well as potential strategies for use of novel technologies in endemic settings.

Partnership with Existing Sites

To accomplish the goals of this initiative, applicants should propose a partnership of investigators and existing clinical study sites in TB endemic countries, coordinated and led by a leadership team, to evaluate early-stage TB diagnostics. The clinical sites must provide access to adult and pediatric study populations with drug-susceptible and drug-resistant TB, and should include populations with co-morbidities including PLWH.

The leadership team will organize, coordinate, and provide oversight for study implementation to evaluate TB diagnostics and will implement a process to identify and prioritize TB diagnostics and biomarkers to be evaluated under the grant, including a process for technology holders to submit requests for diagnostic evaluations.

Your application must include at least one foreign clinical study site located in a TB-endemic country. Study sites should have the facilities and personnel necessary to carry out study-specific laboratory testing in accordance with Good Clinical Laboratory Practice guidelines, store patient samples under appropriate conditions, and diagnose TB according to the current standard of care.

Priority Diagnostics

In your application, you must identify one or more early-stage diagnostics ready for initial testing in the first year of performance and include detailed plans to evaluate additional diagnostics in subsequent years.

NIAID has highlighted diagnostics of interest, including:

• POC or near-to-care tests.
• Diagnostics for use in underserved populations, including children and persons with disseminated or paucibacillary TB disease and PLWH.
• Product candidates that identify TB using specimens other than sputum (e.g., blood, serum, urine, stool, breath, swabs) allowing identification of paucibacillary or extrapulmonary TB in adult and pediatric patients.
• Diagnostics that may overcome limitations such as cost and infrastructure associated with current molecular diagnostic approaches.
• Diagnostics that provide expanded rapid DST, including at the POC.
• Studies to evaluate the performance of diagnostics or host biomarkers in PLWH and people who are not living with HIV.
• Diagnostics that distinguish between vaccinated individuals and those who are infected with TB.

Diagnostic technologies for evaluation may detect TB across the disease spectrum, including identification of asymptomatic or subclinical disease, disseminated extra-pulmonary disease, and paucibacillary disease.

Applications may propose to conduct limited laboratory assessments of a diagnostic prototype to ensure performance and feasibility prior to conducting a clinical evaluation.

However, applications may not include any of the following activities; if an application does, we will consider it nonresponsive and not review it:

• Establishing new clinical infrastructure.
• Establishing a public biorepository (though samples may be stored and used in studies by the study team).
• Developing a new diagnostic prototype.
• Conducting a clinical trial.

In your application, describe your plans to incorporate the following elements into your FEND research program:

• Administration and Leadership Team—to organize, coordinate, and oversee the implementation of studies to evaluate TB diagnostics.
• Clinical Study Sites—to evaluate new TB diagnostics by leveraging established relationships with local clinicians.
• Clinical Support Team—to coordinate procedures related to recruitment, enrollment, and data and biological sample collection at individual enrollment sites.
• Data Stewardship and Analysis Team—to develop and implement procedures for the collection, oversight, and inventory of data and biological samples.
• External Advisory Committee (EAC)—to review progress and share recommendations with NIAID as part of annual programmatic meetings.

FEND investigators and key personnel, NIAID staff, and EAC membership will attend the annual programmatic meetings to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID on issues of need. Further, FEND researchers will participate in quarterly virtual programmatic meetings to discuss ongoing and future activities.

Application Requirements

Your budget request should not exceed $3.5 million in annual direct costs. Your proposed project period must be 5 years.

Foreign organizations are eligible to apply.

The notice of funding opportunity has a single due date: June 28, 2024, at 5 p.m. local time of the applicant organization.