FDA Joins COVID-19 Diagnostics Evidence Accelerator Project

The Diagnostics Evidence Accelerator is the companion project to the previously announced Therapeutic Evidence, which brings together leading experts in health data aggregation and analytics in a unified, collaborative effort to share insights, compare results and answer key questions to inform the collective COVID-19 response.

The key research questions that will be examined through the Diagnostics Evidence Accelerator include evaluating the real-world performance of SARS-CoV-2 diagnostic tests and antibody tests, how they are best used to tailor testing strategies to specific populations, and what test results and data may reveal about the prevalence of disease, chains of transmission, and individual and population-level immunity. This effort will focus on the use of real-world data to understand whether the presence of antibodies can indicate future immunity and if so, which specific antibodies and epitopes contribute to some level of protection against future infection.

Using real-world data can also provide actionable information about the prevalence of SARS-CoV-2 in specific populations and highlight individual risk factors for patients, helping to improve our understanding of the disease, tailor public health interventions and strategies to mitigate risks for individuals and communities, and help stop the spread of SARS-CoV-2. The evidence generated through the Diagnostics Accelerator is intended to be complementary to other studies that have been conducted or are underway as well as to address questions not yet answered.

“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,” said Amy Abernethy, M.D., PhD., FDA Principal Deputy Commissioner.

“This collaboration with the FDA, scientists and data experts is meeting the urgency of the moment to speed the pace of diagnostic testing,” said Ellen V. Sigal, Chair of both the Reagan-Udall Foundation and Friends of Cancer Research. “We all share the goal of deepening our understanding of COVID-19 on every front to ensure that patients receive the best care as quickly and safely as possible.”

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US Food and Drug Administration (FDA)