Real-World Performance of In Vitro Diagnostics (PIVD)
The Reagan-Udall Foundation for the FDA (FDA Foundation) has 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) or full market approvals (FMA).
The FDA Foundation awarded $1.8 million in funding for two PIVD research projects. 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. More information about the awardee projects is available here.
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 or FMA.