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Clinical Lab Products – FDA to Participate in Covid-19 Diagnostics Evidence Accelerator Project

Clinical Lab Products – FDA to Participate in Covid-19 Diagnostics Evidence Accelerator Project

To take an additional step toward harnessing real-world data to help inform the agency’s overall response to the covid-19 public health emergency, FDA has announced its participation in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.


“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,” says Amy Abernethy, MD, PhD, FDA principal deputy commissioner. “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.”


The Diagnostics Evidence Accelerator is the companion project to the previously announced Therapeutic Evidence Accelerator, 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.


“This collaboration with FDA, scientists, and data experts is meeting the urgency of the moment to speed the pace of diagnostic testing,” says 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.”


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.


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