Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used PCR-based diagnostics and serological antibody tests.

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a potentially lasting and positive impact on the agency’s view of the utility of RWE to support – or even guide – drug approvals and labeling expansions beyond the context of the current public health emergency.

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.