Improved Diagnostic Assays for Parasitic Diseases

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 Parasitic diseases are ubiquitous around the world and disproportionately affect poor and underserved populations. Despite medical advances and high standards for water and sanitation, parasitic diseases still affect many people in the United States (US). Diagnostic methods for most parasitic diseases currently rely on laboratory developed tests (LDT), limiting their availability to a few reference laboratories, and increasing time to results due to specimen shipping. Modern diagnostic methodologies can be used to improve the robustness of existing LDTs and expand their availability to a larger proportion of the US population. Modernized assays will also lead to shorter time to results that will expedite clinical or public health decisions. Parasitic diseases have a wide range of clinical presentations, from asymptomatic to debilitating or life-threatening. For example, Chagas disease can be congenitally transmitted, with negative prognosis among infected newborn children. Strongyloidiasis and Chagas disease can be transmitted through organ transplantations, that if not detected can lead to life-threatening conditions. Taeniasis/cysticercosis, hydatic disease and infections with flukes cause mild to serious infections that affect the brain or other solid organs and are challenging to diagnose with existing methods, sometimes requiring invasive procedures. Other parasitic infections like lymphatic filariasis or soil transmitted helminths are still endemic in specific regions of the US, while leishmaniasis may be emerging.