Structural Challenges in Deployment of an Open-Source Diagnostic by Independent Researchers During a Public Health Emergency

ABSTRACT

Open-source diagnostic products have the potential to address some of the major challenges of diagnostic access revealed during the COVID-19 pandemic. However, as it stands, the current approval model in the US is poorly suited for such tests. In March 2020, early in the COVID-19 pandemic, a small group of independent scientists with members located in Illinois, New York, and Georgia collaborated on developing an open-source, patent-free COVID-19 diagnostic test. Within a few short months, we had developed a reliable test and published the protocol online with the hope that this simple, yet sensitive test would be adopted for widespread testing in laboratories, schools, and workplaces. However, we encountered several unexpected barriers to deployment of the test. This essay describes our experience and proposes a novel solution to reduce the barriers that limit meaningful contributions by independent researchers to addressing healthcare challenges in the United States. © 2022 Ubiquity Press. All rights reserved.