Development of CRISPR-based in vitro diagnostics for rapid detection of mycobacteria
Forecast New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- Total Small Business
Forecast facts
- Anticipated award
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Points of contact
-
- Callie Prassinos callie.prassinos@nih.gov (240) 669-5155
- Karen Lacourciere lacourcierek@niaid.nih.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health forecasts a new requirement to develop CRISPR-based in vitro diagnostics for rapid detection of mycobacteria, with an estimated solicitation release date of May 1, 2027 and an estimated award date of March 1, 2028. Activities may include developing prototype assays with rapid, low-cost readouts to diagnose tuberculosis, identify non-tuberculous mycobacteria species, or determine drug resistance, along with validating internal process controls and determining sensitivity, specificity, and other performance characteristics. Scope may also include testing on laboratory isolates, developing a test platform under good manufacturing practices (GMP), scale-up and production for multi-site evaluations using clinical samples, and a product development strategy for regulatory approval.
The procurement is set aside for Total Small Business under NAICS 541714, Research and Development in Biotechnology (except Nanobiotechnology), with an estimated award value range of $3.0 million to $7.0 million. Callie Prassinos, Contracting Officer (callie.prassinos@nih.gov, +1 240-669-5155), and Karen Lacourciere, Program Officer (lacourcierek@niaid.nih.gov), are the points of contact.
Forecast text
The goal of this solicitation is to develop Clustered regularly interspaced short palindromic repeats (CRISPR)-based in vitro diagnostics to diagnose tuberculosis (TB) or to rapidly identify the species of non-tuberculous mycobacteria (NTMs) pathogens, or to determine drug resistance for TB or NTMs. Activities may include development of initial CRISPR-based diagnostic prototype assays with rapid and low cost readouts, integration, and validation of internal process controls for diagnostics, determination of the sensitivity, specificity and other performance characteristics of the diagnostic, testing on laboratory isolates, development of well-defined test platform under good manufacturing practices (GMP), scale up and production for multi-site evaluations using clinical samples and development of a product development strategy for regulatory approval and demonstration of clinical application
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