CREATION OF STANDARDS AND DEVELOPMENT OF MOLECULAR CLINICAL DIAGNOSTIC FOR ENTERI

DESCRIPTION (provided by applicant): This one-year phase I SBIR proposal will apply the benefits of molecular testing, in terms of speed, sensitivity, and ultimately value, to diagnose enteric Microsporidia (Enterocytozoon bieneusi and Encephalitozoon intestinalis). Molecular diagnostics are the future for infectious disease diagnostics, with a projected 13% rate of revenue increase between 2009 and 2013 (Maneshwari, 2009). This industry is presently dominated by companies that sell reagent/platform combinations for high volume tests such as HIV and Chlamydia, leaving many smaller market infectious diseases of public health importance underserved. The proposed work will bring the benefits of molecular testing, in terms of speed, sensitivity, and ultimately cost, to enteric Microsporidial diagnostics. The lack of a robust diagnostic test for Microsporidiosis has limited epidemiological studies, thus it is imperative to develop such a diagnostic product. Upon successful completion of the proposed phase I, a phase II application will be submitted to complete development and obtain validation data sufficient for an FDA 510(K) application for this Microsporidia diagnostic test. The innovation of this application lies in the concept of bringing state-of-the-art diagnostics to underfunded infections of public health importance, as well as in development of molecular standards that have utility far surpassing the goals of this proposal. In addition to providing significant improvement in clinical diagnostics, the proposed work will also create valuable tools for epidemiological and drug discovery studies. PUBLIC HEALTH RELEVANCE: The proposed Phase I SBIR will develop a modern, molecular diagnostic product for intestinal Microsporidia. This product will incorporate the use of molecular standards and internal controls to create a robust diagnostic test for two enteric Microsporidial infections of public health importance for use in today's clinical laboratory.