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, which also include the requirement to have IRB approval.

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 its at-home test. The test has already received authorization from the Washington State Department of Health and has not raised safety or accuracy questions with the agency but requires an additional EUA because it is used by the patient at home.

“Any COVID-19 test for at-home testing, with or without the use of telemedicine, requires an authorized EUA,” an FDA spokesperson said. “Home collection raises additional concerns about safety and accuracy that require FDA review, as we have discussed in our FAQs and other communications about home collection.”

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. The network began the process to authorize the lab-developed test and self-swab kit on March 23 and submitted data to secure the authorization on April 13, in line with the EUA process and timeline, it said.

The network said it is working to address the agency’s inquiries — including questions about its testing of patients that have not reported COVID-like illness — and to continue research as soon as possible. — James Miessler