GoDx Phase 2 Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need In this Phase 2 SBIR project, we will be developing the prototype multiplexed paper strip device for the detection of gastrointestinal pathogens at the point-of-need in < 30 minutes. We have demonstrated the feasibility of a novel and simple stool sample preparation using hollow microsphere ?molecular buoys?, and the multiplexed detection of DNA using isothermal amplification in Phase 1. In Phase 2, we will develop and evaluate our multiplexed prototype device. We will evaluate the prototype device using 800 samples from an NIH-IRB approved protocol through our CRADA collaboration with Dr. Wendy A. Henderson at the NIH. We expect a sensitivity (>90%) and specificity (>90%) to the Biofire PCR GI Panel data on the same samples. The goal of the Phase 2 project is to develop an optimized prototype that will be evaluated in the IDE-exempt NIH clinical study. We will also develop for commercialization a Research Use Only kit for the point-of-need purification of nucleic acids using our microsphere sample preparation technology.
Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need GoDx Project Narrative Approximately 1.7 billion episodes of childhood diarrhea are reported each year worldwide, with 1,600 deaths occurring daily in children under the age of 5. An effective low-cost test to identify the pathogens causing persistent infectious diarrhea may help guide prompt infection control and appropriate treatment and reduce antimicrobial resistance from antibiotic overuse. We are developing a simple, rapid and sensitive paper strip test to identify gastrointestinal pathogens that cause diarrheal disease without the use of expensive instrumentation at the point-of-need.
