The FDA announced that it is participating in the COVID-19 Diagnostics Evidence Accelerator project to advance the development of diagnostics.
Organized by the Reagan-Udall Foundation for the FDA and in collaboration with Friends of Cancer Research, the multi-stakeholder project is the companion to the previously announced Therapeutic Evidence Accelerator for sharing insights, comparing results and answering key questions to inform the collective COVID-19 response.
Strategies involved in the latest collaboration include evaluating real-world performances of SARS-CoV-2 diagnostic and antibody tests to determine if the presence of antibodies can indicate future immunity and, if so, which specific antibodies and epitopes contribute to protection against future infection.
Other uses of real-world data can provide information about the prevalence of SARS-CoV-2 in specific populations and highlight individual risk factors, according to an FDA news release. Evidence generated through the accelerator is intended to complement other studies.
“While there are current studies of viral diagnostic and antibody tests using traditional assessment methods, the 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,” FDA principal deputy commissioner Dr. Amy Abernethy said in the release. “FDA’s participation in the Diagnostics Evidence Accelerator is another example of how we are working with a broad set of experts in healthcare data and analytics to understand the performance of SARS-CoV-2 tests and to inform clinical and public health decision-making.”