Regulatory Issues Freeze Bill Gates-Backed COVID-19 Study
A Seattle-based study of how COVID-19 spreads through the community has put its project on hold at the FDA’s request until it receives an Emergency Use Authorization (EUA) for its lab-developed test and self-swab kit.
The agency has received criticism from the research community for its handling of the case, with questions being raised about why the FDA asked the researchers to stop temporarily instead of working with them to resolve the regulatory issues.
The Seattle Coronavirus Assessment Network (SCAN) said the FDA asked it to pause testing of the home-based, self-collected COVID-19 samples it uses in its research project until it has received an EUA for the test.
SCAN, which is funded by the Bill and Melinda Gates Foundation, said that it has been in talks with the FDA since March 1 and hopes to receive an EUA for the test soon.