Develop Rapid, Portable, Point-of-Care C. auris Diagnostic

Phase I SBIR proposals will be accepted. Fast-Track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I: up to $243,500 for up to 6 months; Phase II of up to $1,000,000 and a Phase II duration of up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Candida auris is an emerging multidrug resistant fungal pathogen that has spread rapidly through networked healthcare facilities in the United States since it was first identified in 2016. C. auris heavily colonizes patients' skin and extensively contaminates the healthcare environment, making this pathogen highly transmissible and hard to control. The admission of just a single colonized patient can lead to sustained outbreaks in facilities caring for highly vulnerable populations. Colonization is an established risk factor for subsequent C. auris infections, which have high associated morbidity and mortality, and are difficult to treat. Rapid identification of C. auris is therefore essential for the timely implementation of infection control measures. Currently, C. auris colonization screening is primarily performed by specialized regional public health laboratories when validated as lab-developed tests (LDT). The dependency on highly specialized laboratories limits the total capacity for C. auris colonization screening, and is not ideal for admission screening, which is best implemented at the point of care. Because C. auris impacts many healthcare facilities that do not have laboratories, efficient admission screening is not feasible with existing technologies. A simple, fast, and portable test that could be performed at the point of care in resource limited settings, without requiring specialized laboratory equipment, would greatly improve testing capacity and broader C. auris response efforts. The purpose of this work is to support development of such a test. Project Goals 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 Phase 1 deliverables should include a functional prototype and preliminary data indicating potential for further development. Expected Phase I deliverables include: 1. A physical prototype suitable for further testing. 2. Preliminary assessment of the prototype's ability to detect C. auris. This assessment should utilize fresh cultures of C. auris AR 0381, when normalized to concentrations of ~105 CFU/mL in AMIES buffer. This isolate is freely available through the CDC-FDA AR bank. Data from biological replicates, performed on different days, should be provided. Page 126 3. Preliminary assessment of the prototype's specificity. This assessment should utilize cultures of Saccharomyces cerevisiae AR 0399, when normalized to concentrations of ~105 CFU/mL in AMIES buffer. This isolate is freely available through the CDC-FDA AR bank. Data from biological replicates, performed on different days, should be provided. 4. A report summarizing progress including both raw and summary data. Impact A simple, fast, and highly portable test that can be performed at the point of care, even in resource-limited settings, will improve public health efforts to control C. auris. The requested test will help expand capacity by enabling healthcare facilities to determine their patient's colonization status upon admission without sending samples to a specialized laboratory. This will help facilities act quickly when positive cases are identified, and therefore provide a greater opportunity to control C. auris before an outbreak occurs. Commercialization Potential If successful through all phases, this technology would result in a diagnostic test that could be commercialized and marketed directly to healthcare facilities. Demand would be driven by increasing awareness and growing financial incentives for facilities to reduce healthcare-associated infections. This test would provide a valuable tool to this end by helping healthcare facilities prevent C. auris-related transmission and infections.