Research group to harness data from COVID-19 tests

June 19, 2020

The U.S. Food and Drug Administration (FDA), the Reagan-Udall Foundation, and the Friends of Cancer Research launched the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder, collaborative project to leverage real-world data from COVID-19 molecular and serology tests.

The Diagnostics Evidence Accelerator brings together device manufacturers, technology companies, government and academic researchers, professional societies, payers, and health systems to review recent analyses of real-world data related to test performance, contemporaneous symptoms and presentation, real-time surveillance trends, and immunity.

“The Diagnostics Evidence Accelerator is a significant step toward harnessing the full potential of real-world data to tackle the COVID-19 pandemic,” said Amy Abernethy, MD, PhD, FDA Principal Deputy Commissioner. “Leveraging real-world data collected from patients can contribute to our scientific evaluation of viral diagnostic and antibody tests, gain a deeper understanding of the prevalence of SARS-CoV-2 in specific populations, and potentially answer critical questions on immunity.”

The Diagnostics Evidence Accelerator builds on the framework and methodologies already in place for the COVID-19 Therapeutics Evidence Accelerator launched in April.

The FDA said it hopes the insights gained from the accelerator’s work will help the government tailor public health interventions and strategies to mitigate risks for individuals and communities.

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