The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of tests.
Formed by the Reagan-Udall Foundation and Friends of Cancer Research, the COVID-19 Diagnostics Evidence Accelerator will work to collaborate with test manufacturers, technology companies and government and academic researchers, as well as professional societies, payers, and health systems.
It aims to provide real-world analyses evaluating the performance of both PCR and antibody tests—presented alongside coronavirus surveillance trends and research into the disease’s symptoms, progression and potential immunity—as a companion project to the groups’ previous Therapeutic Evidence Accelerator, which launched in April.
“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 Sigal, who serves as 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.”
Nearly 50 organizations have participated in initial meetings so far, they said, to help develop strategies for measuring test performance and the potential role of real-world data.
“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 the FDA’s principal deputy commissioner, Amy Abernethy.
“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,” Abernethy said.
One of the key research questions will be how to develop the best testing strategy for specific populations, and what the data provided from diagnostic and antibody screenings can say about COVID-19’s broader impact. It will also explore the connection between the presence of antibodies and any conferred immunity to the disease.
“We recognize that questions related to the accuracy of diagnostic tests require different data elements that are not as widely available as those in the therapeutic space. They also require a different approach to data integration and analysis,” said Jeff Shuren, Director of the FDA's Center for Devices and Radiological Health.
“The aim of the accelerator is to propose questions, refine them, evaluate the feasibility of different approaches, and bring together groups that have the data to answer the questions and develop lasting solutions,” Shuren said. “Ultimately, we hope that real-world data can provide a more generalizable and rapid read-out of results than traditional clinical trials.”