PROMPT DIAGNOSTICS LLC — Department of Health and Human Services SBIR Phase I: 28
PROMPT DIAGNOSTICS LLC — SBIR Phase I award from Department of Health and Human Services.
- Amount
- $243,179
- Agency
- Department of Health and Human Services · Centers for Disease Control and Prevention
- Program / Phase
- SBIR · Phase I
- Topic
- 28
- Solicitation
- PHS 2022-1
- NAICS
- —
- Place of performance
- MD
- Period
- —
Description
Purpose: The goal is to develop a simple, fast and highly portable test that could be performed at the point of care, even in resource-limited settings, without a laboratory. Dipsticks and Lateral Flow Assays are examples of how such a test could be achieved. The test should detect an analyte directly indicative of C. auris rather than an associated antibody or other immune response indicator of exposure. The test should generate results that can be interpreted without the requirement of sophisticated equipment, such as a visually observable color change, or appearance of a positive indicator, as commonly seen in CLIA-waved test platforms. Each individual test should include an internal positive control sensitive to inhibitors. External positive and negative controls should also be provided, which could be accomplished through inclusion in a kit of multiple tests, or as otherwise appropriate, to sufficiently control for the associated production lot. Phase I Activities and Expected Deliverables