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Regulatory Focus – New accelerator to boost real-world COVID-19 diagnostics

Regulatory Focus – New accelerator to boost real-world COVID-19 diagnostics

A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID-19.

The Diagnostics Evidence Accelerator is a joint project between the Reagan-Udall Foundation for the Food and Drug Administration and the nonprofit Friends of Cancer Research; more than 50 collaborators were initially involved in laying out the scope and depth of work that Accelerator participants are seeking to accomplish. Participants in the Diagnostics Evidence Accelerator include device manufacturers, technology companies, researchers from the academic and public sectors, professional societies, payers and health systems, said the Foundation in announcing the Accelerator’s launch.

Use of the Diagnostics Evidence Accelerator will aid research into the real-world performance of SARS-CoV-2 diagnostic and antibody tests, said the US Food and Drug Administration (FDA) in its announcement of the Accelerator. Also, Accelerator participants will see how use of specific tests fit into broader testing strategies such as addressing COVID-19 incidence and prevalence in specific populations. Having a mechanism to collect and analyze real-world performance of the tests is especially important in the context of the public health emergency of the pandemic, since many tests now in use came to market under emergency use authorizations (EUAs).

The Diagnostics Evidence Accelerator is also expected to help answer broader questions. These include finding patterns of prevalence, learning more about transmission chains, and discovering whether immunity is being achieved within populations or for individuals.

“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, MD, JD, Director of 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. Ultimately, we hope that real-world data can provide a more generalizable and rapid read-out of results than traditional clinical trials.”

Output from the Diagnostics Evidence Accelerator, said FDA, is intended to complement other research, but the Accelerator will also seek to resolve yet-unanswered questions. As real-world data is sifted and analyzed, results should provide “actionable data” regarding both individual risk factors for patients and prevalence of SARS-CoV-2 within particular patient populations.

“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, 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.”

Giving researchers, clinicians, and public health officials better access to real-world diagnostics data comes at a critical time, said Ellen V. Sigal, PhD. “We are at a pivotal point where testing and diagnostics are absolutely critical in understanding the spread of COVID-19 and how to best manage reopening the country,” said Sigal, who chairs both the Reagan-Udall Foundation and Friends of Cancer Research.

A COVID-19 Therapeutics Evidence Accelerator was established in April 2020, using similar organization and methodology to share new findings and insights in order to ascertain best practices for treating the novel coronavirus.

The Reagan-Udall Foundation for the FDA is an independent nonprofit organization created by Congress with the aim of helping FDA accomplish its mission by advancing regulatory science.…