Real-World Performance of In Vitro Diagnostics (PIVD)

In March of 2022, the Reagan-Udall Foundation for the FDA (FDA Foundation) launched its first research funding program to evaluate the Real-World Performance of In Vitro Diagnostics (PIVD). The purpose of this research program is to evaluate real-world performance for two types of diagnostic tests (antigen and molecular) and to determine how RWD/RWE can be leveraged for Emergency Use Authorizations (EUA) to market authorization.

The FDA Foundation awarded $1.8 million in funding for two PIVD research projects. Beth Israel Deaconess Medical Center studies antigen and molecular COVID-19 tests using real-world patient data. IDx20 compared 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. More information about the awardee projects is available in their research papers below. An analysis of both projects is also available.   

Research results are expected to increase knowledge of real-world diagnostic test performance while informing a framework for IVD test developers to collect and analyze data for regulatory submissions. Projects may enable regulatory submissions from SARS-CoV-2 IVD manufacturers for EUA.