Improved Drug Susceptibility Testing (DST) for Mycobacteria

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.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...