The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by supporting research to develop improved drug susceptibility tests (DSTs) for mycobacterial drugs, including those currently used for treatment of tuberculosis (TB) and clinically important non-tuberculous mycobacterial (NTM) infections, new drugs and drugs in late-stage clinical development. TB is a leading cause of death from an infectious disease worldwide and drug-resistant strains of TB, including those resistant to new drug regimens, are increasing. In the United States, rates of NTM lung disease are rising, especially among women and older adults, while TB cases have surged to their highest level in ten years. Current assays utilize slow, culture-based processes that do not allow for the rapid testing of mycobacterial strains and their drug susceptibility. Improved DSTs are essential for guiding effective treatment, reducing drug-resistant mycobacterial rates, and preventing new transmissions. This program will support the development of innovative DST assays, including rapid genotypic and improved phenotypic methods that do not require full culture growth. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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