Rapid and Simple Paper Strip Test for the Multiplexed Detection of Gastrointestinal Pathogens at the Point-of-Need

PROJECT SUMMARY GoDx, Inc. has been developing a prototype multiplexed paper strip device for the detection of the DNA and RNA of gastrointestinal pathogens at the point-of-need in andlt; 30 minutes with funding from the NCATS SBIR parent grant TR 001912. We have used the same platform technology we are developing in the parent grant to develop a rapid (andlt;30 minute), low-cost and instrument-free paper strip test for SARS-CoV-2 that can be performed in a wide range of settings. Our tests are more sensitive than the antigen tests since the RNA of the virus are exponentially amplified. The value proposition of this test is that it is fast and readily available to the patient (30 minutes at the doctorandapos;s office with a simple, physicianandapos;s office laboratory vs 2-3 days sending samples to a laboratory) which allows faster isolation and treatment of the patient. Our test will also be valuable in laboratories and hospitals with limited resources in the developed and the developing world that do not have an RT-PCR instrument to test for coronavirus. We propose the commercialization of a simple, rapid, ow-cost and instrument-free test to detect SARS-CoV-2. We will perform the analytical and clinical validation required for the FDA Emergency Use Authorization (EUA). We will also manufacture and commercialize our test.PROJECT NARRATIVE In the United States alone, there are more than 6 million confirmed cases of COVID-19 and 185,000 deaths. Six months into the pandemic, there are still delays in testing for the virus. We are developing and commercializing rapid (andlt;30 minute), instrument-free, paper strip tests for COVID-19 to accelerate testing and stop the pandemic.