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.
Public Health Relevance Statement: 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.
Project Terms: AIDS Virus; AIDS/HIV; AIDS/HIV problem; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Algorithms; Arts; Assay; Bioassay; Biologic Assays; Biological Assay; Businesses; Chlamydia; Clinical; Communicable Diseases; Computer Simulation; Computerized Models; Consensus Sequence; ConsensusSequence; DNA; Data; Data Banks; Data Bases; Databank, Electronic; Databanks; Database, Electronic; Databases; Deoxyribonucleic Acid; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Diarrhea; E. intestinalis; Encephalitozoon (Septata) intestinalis; Encephalitozoon intestinalis; Enteral; Enteric; Enterocytozoon bieneusi; Epidemiologic Research; Epidemiologic Studies; Epidemiological Studies; Epidemiology; Epidemiology Research; Feces; Future; Gastrointestinal Tract, Feces; Genomics; Goals; HIV; HIV/AIDS; HIV/AIDS problem; HTLV-III; Human; Human Immunodeficiency Viruses; Human T-Cell Leukemia Virus Type III; Human T-Cell Lymphotropic Virus Type III; Human T-Lymphotropic Virus Type III; Human, General; Industry; Infection; Infectious Disease Pathway; Infectious Diseases; Infectious Diseases and Manifestations; Infectious Disorder; Intestinal; Intestines; LAV-HTLV-III; Laboratories; Left; Lymphadenopathy-Associated Virus; Man (Taxonomy); Man, Modern; Marketing; Mathematical Model Simulation; Mathematical Models and Simulations; Methods; Microscopic; Microspora; Microspora Infections; Microsporidia; Microsporidia (protozoa); Microsporidiosis; Miyagawanella; Models, Computer; Molecular; Molecular Bank; Molecular Diagnostic Testing; Organism; Patients; Performance; Phase; Prevalence; Public Health; Reagent; Reporting; Reproduction spores; Research Specimen; S. intestinalis; SBIR; SBIRS (R43/44); Sampling; Sensitivity and Specificity; Septata intestinalis; Simulation, Computer based; Small Business Innovation Research; Small Business Innovation Research Grant; Source; Specimen; Speed; Speed (motion); Spores; Testing; Testing, Molecular Diagnostic; Time; Validation; Vendor; Virus-HIV; Work; base; bedsonia; bowel; clinical data repository; clinical data warehouse; computational modeling; computational models; computational simulation; computer based models; computerized modeling; computerized simulation; cost; data repository; design; designing; drug discovery; improved; in silico; innovate; innovation; innovative; internal control; living system; pathogen; prototype; public health medicine (field); public health relevance; relational database; response; stool; tool; virtual simulation
