September 2021 NIAID Council-Approved Concepts

Improved Drug Susceptibility Testing (DST) for Tuberculosis!

Request for Applications—proposed FY 2023 initiative

Objective: To support the development of new diagnostic technologies for tuberculosis (TB) drug susceptibility testing (DST), including point-of-care DST and companion diagnostics for new TB drugs.

Description: This concept would further the development of new diagnostic technologies for TB DST with an emphasis on rapid, point-of-care, low complexity assays. As new drugs move forward in the pipeline, there is a need for companion DST diagnostics for new drugs to ensure new drugs are used most effectively. Current phenotypic methods for determining drug resistance (DR) provide clinically relevant drug susceptibility information but have limitations. For example, the gold standard relies on culture, requires time for growth, and does not provide a result for many days. The program would solicit highly innovative DST assays, including phenotypic DST that may rely on a readout that does not require full growth as in traditional DST assays. Innovative technologies beyond nucleic acid amplification tests will be encouraged. This effort is anticipated to include exploratory work that would further improve our knowledge of genotypic and phenotypic correlates of clinical DR, which can be complex. Research that leverages the rapid advances in diagnostic technologies for COVID-19 applied to TB are also encouraged. Furthermore, this effort would be targeted to technology holders partnered with academic, clinical, and laboratory colleagues with TB diagnostic expertise.

Contact: Karen Lacourciere

lacourcierek@niaid.nih.gov

240-627-3297

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