Funding To Discover and Validate Novel Biomarkers, Diagnostics for Tuberculosis Diagnosis

Funding News Edition: May 02, 2019
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NIAID recognizes a need for non-sputum-based tuberculosis (TB) diagnostics for use in HIV-1-infected and HIV-1-exposed uninfected children to improve and simplify rapid and decentralized diagnosis of TB disease. To support biomarker discovery and biomarker-based assay development, NIAID will fund R01 research projects through the new funding opportunity announcement (FOA) Advancing Biomarker Discovery and Novel Point-of-Care Diagnostics for Active TB Disease Detection in HIV-1 Infected and Exposed Children (R01, Clinical Trial Optional).

In your application, propose biomarker discovery activities such as the following:

  • Host RNA transcript expression profile
  • Proteomics (hosts or pathogen derived)
  • Metabolomics
  • Mycobacterium tuberculosis antibody functional profiling (e.g., effector function, glycosylation pattern)
  • Immune cell profiling
  • Other biomarkers (e.g., extracellular vesicles/exosomes)
  • Discovery activities involving more than one biomarker type (e.g., multi-omics)

You can also propose to develop and evaluate novel ultrasensitive detection tools or other diagnostic technologies. Establish industry support or partnerships to help translate promising TB diagnostic tools. The biomarkers evaluated by these detection diagnostics should be:

  • Measurable in small volumes of readily obtainable samples such as blood, urine, or stool
  • Able to identify TB with high sensitivity and specificity regardless of patient age, nutritional status, or HIV status
  • Able to distinguish children with active TB disease from latently infected children
  • Able to discriminate along the spectrum of TB disease including TB’s absence, as well as potentially confounding conditions
  • Promising for development as point-of-care (POC) tools

Keep in mind, prioritizing applicability to HIV-1-infected children is paramount.

See the FOA linked above for additional details, including required and nonresponsive elements of applications. For example, you must meet or exceed Target Product Profile (TPP) proposed for high priority biomarker-based, non-sputum-based, POC tests for TB disease detection by the WHO TPP Consensus Meeting on New Tuberculosis Diagnostics. Conversely, if you propose cohorts or samples that do not include HIV-infected children less than five years of age, NIAID will deem your application nonresponsive and not review it.

Administrative Details

Applications are due July 30, 2019. Send an optional letter of intent by June 30, 2019.

Your application budget is not capped but needs to reflect the actual needs of your proposed project. Your project period, however, is capped at five years.

If you have any questions, contact Judi Miller, NIAID’s scientific/research contact for this FOA.

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