FDA Joins COVID-19 Diagnostic Development Initiative

The FDA has said it will join a collaborative effort to speed up the development of coronavirus diagnostics through the use of real-world data.

The COVID-19 Diagnostics Evidence Accelerator “will allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19," said the agency’s Principal Deputy Commissioner Amy Abernethy.

The project, which was organized by the Reagan-Udall Foundation at the agency’s request, will evaluate the real-world performance of COVID-19 diagnostics and antibody tests, how they should be used in specific populations, and what test results and data can show about disease prevalence, transmission chains and patient and population immunity.