Developing an Over-the-Counter Diagnostic for Valley Fever

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 $2,045,816 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 Valley fever, also known as coccidioidomycosis, is an infectious fungal disease that can result in substantial illness and death. People can get Valley fever by breathing in the microscopic fungal Coccidioides spp. spores from the air. Infections range from an asymptomatic, subclinical infection to a symptomatic, protracted but usually self-limited pulmonary illness presenting as pneumonia to a progressive and often life-threatening extra-thoracic disseminated infection. In southwestern U.S. endemic regions, Valley fever infections are responsible for up to one-third of community acquired pneumonia cases, and the annual economic impact is approximately $1.5 billion. Experts estimate that up to 150,000 infections occur in the United States each year. Other endemic areas include parts of Mexico, Central America, and South America, and there is evidence that the geographic range is expanding. Currently, no therapy is curative, and a preventative vaccine does not exist. Like many fungal diseases, early detection is critical tosuccessful treatment. In addition, because symptoms of Valley fever are indistinguishable from those caused by other types of the community acquired pneumonia (CAP), over 70% of patients with Valley fever go through multiple rounds of unnecessary treatments with antibiotics before getting a correct diagnosis. The COVID-19 pandemic demonstrated the utility of at home diagnostic tests as valuable tools for identifying infected individuals. An over the counter (OTC) diagnostic for coccidioidomycosis would not only save lives and improve outcomes for people who are at risk of developing severe infections but would also prevent thousands of unnecessary prescriptions of antibiotics.