Draft an NIH R34 phased-innovation grant proposal section outlining iterative prototype development milestones for a CRISPR-based diagnostics device targeting drug-resistant tuberculosis in endemic low-resource settings

Generate draft an nih r34 phased-innovation grant proposal section outlining iterative prototype development milestones for a crispr-based diagnostics device targeting drug-resistant tuberculosis in endemic low-resource settings for Scientific Research and Development Services industry

Scientific Research and Development Services

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Upload pre-clinical data, pilot results, or prior publication packages from mouse or guinea pig TB models that establish proof-of-concept for your CRISPR detection platform
Indicate the current Technology Readiness Level (TRL) of your CRISPR diagnostics prototype to set appropriate Phase I milestones
Specify the primary low-resource deployment environment to align device requirements with endemic infrastructure constraints
Identify the intended regulatory strategy for CLIA waiver and WHO prequalification in endemic countries
Select all target product profiles (TPP) for analytical and clinical validation from WHO TB diagnostic TPPs
Specify the skill level and training capacity of intended operators in endemic settings
Define the specific drug resistance mutations and loci to be included in Phase I prototype validation
Select the coordinated implementation approach for iterative prototype testing
Choose the cost-effectiveness model consistent with WHO TB diagnostics economics guidelines
Describe any hard constraints on iterative prototype development timelines, including sputum sampling logistics, ethical approvals, or seasonal TB diagnosis variations