New FOA To Evaluate Novel TB Diagnostics

Funding News Edition: May 15, 2019
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Tuberculosis (TB) now ranks as the leading infectious disease cause of mortality in the world. Early diagnosis of TB and universal drug-susceptibility testing (DST) are critical to identifying the most appropriate treatment for individual patients and preventing the spread of disease. Despite major advances in recent years, we have yet to meet critical diagnostic needs.

NIAID strives to change that through a new funding opportunity announcement (FOA): Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND for TB) (U01, Clinical Trial Not Allowed). The FOA supports proof-of principle studies to evaluate novel, early-stage* TB diagnostic tests, assays, and strategies as well as provide feedback to diagnostic developers on technology performance and potential strategies for use in endemic settings.

Successful awardee(s) will have clinical sites suitable for evaluating TB diagnostics and one or more early-stage diagnostics ready for initial testing in the first year of performance along with detailed plans to evaluate additional diagnostics in subsequent years. NIAID anticipates that plans will include mechanisms to identify and solicit novel diagnostics for testing and provide a process for third-party diagnostics developers to request evaluation of their technology. 

*For this FOA, an "early-stage" diagnostic refers to one that has advanced to the stage where a prototype is ready and available to be evaluated but is not currently used in clinical care and treatment decisions for TB. 

Areas of Interest

Support will be provided for evaluating novel diagnostic strategies for TB in the context of existing clinical algorithms in TB endemic countries. 

Applications addressing any of the following are of particular interest:

  • True point of care (POC) tests
  • Tests that identify TB using specimens other than sputum (e.g., serum, urine, or stool)
  • Tests that identify paucibacillary or extrapulmonary TB in adult and pediatric patients
  • Diagnostics for use in underserved populations, including children and people with disseminated and/or paucibacillary TB disease
  • Diagnostics that:
    • May overcome limitations associated with current molecular diagnostic approaches such as cost and the need for complex infrastructure
    • Provide expanded rapid drug susceptibility testing, including at the POC
    • Distinguish between vaccinated individuals and those who are infected

Program Infrastructure

A partnership of investigators and existing clinical study sites in TB endemic countries will work together to meet FOA objectives. In addition to a leadership team and clinical study sites, the program is composed of a clinical support team, data management and analysis team, and an external advisory committee. Find descriptions of each in the FOA.

Award Information, Deadlines, Contact

NIH intends to fund one or two awards, corresponding to a total of $4 million for fiscal year 2020. Future year amounts will depend on annual appropriations. 

Application budgets are not limited but need to reflect the actual needs of the proposed project, the scope of which should determine the project period, which in turn is limited to five years.     

Applications are due by July 22, 2019. If you plan to submit an optional letter of intent, do so by 30 days before the application deadline.

As always, carefully read the FOA for complete details. If you have questions, direct them to Dr. Karen Lacourciere, the scientific/research contact.

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