(March 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) awarded $1.8 million in funding for two research projects evaluating the Real-World Performance of In Vitro Diagnostics (PIVD). Beth Israel Deaconess Medical Center will receive $898,045 to study antigen and molecular COVID-19 tests using real-world patient data. IDx20 will receive $893,500 to compare the performance of COVID-19 antigen tests in clinical settings versus real-world data collection. Their project includes a coalition of teams from the City of Chelsea, MA.  

“The work we’re supporting with the PIVD program through these two projects will contribute to the still growing knowledge base about SARS-CoV-2 diagnostic tests,” said FDA Foundation CEO, Susan C. Winckler, RPh, Esq. “We look forward to following the progress of this work and the insights it may provide towards the use of real-world data and real-world evidence in regulatory submissions.” 

• Beth Israel Deaconess Medical Center will examine both antigen and molecular COVID tests to better identify those individuals infected and infectious with SARS-CoV-2 as well as determine how viral loads may or may not vary across real-world patient populations.
• IDx20’s project will create a set of standardized tools to quantify and compare the performance of COVID-19 antigen tests in clinical settings versus real-world data collected on frequent self-testing and self-reporting participants in an underserved and primarily Latino population. The project will be executed by IDx20 team and The Chelsea Project, a coalition which includes The Chelsea Housing Authority, Chelsea Public Health and the Center of Complex Interventions. BioIT Solutions, based in Silver Spring, MD, developed and operates the mobile application and data management system. 

Research results are expected to increase knowledge of real-world diagnostic test performance while informing a framework for in vitro diagnostics (IVD) test developers to collect and analyze data for regulatory submissions. Findings may enable regulatory submissions from SARS-CoV-2 IVD manufacturers for Emergency Use Authorization or full market approvals. 

Accurate and reliable SARS-CoV-2 diagnostic tests remain a critical component of the COVID-19 pandemic response; however, the collection and transmission of testing data remain a challenge. This is particularly true for non-lab-based tests, which are often not designed to capture and transmit diagnostic, demographic, or clinical data. The increasing availability of tests combined with a rapidly evolving pandemic environment creates critical demand for assessing real-world performance using timely, complete, and high-quality data. 

All funding will be issued pending final execution of award agreements. The PIVD award program, managed by the FDA Foundation, is supported by the U.S. Food and Drug Administration of the U.S. Department of Health and Human Services as part of an award of $2,070,437 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit www.fda.gov.