Get all the latest news on coronavirus and more delivered daily to your inbox. Sign up here.
Continue Reading Below
The Seattle Coronavirus Assessment Network (SCAN) uses home-based, self-collected samples and said in a statement that the FDA pressing the pause button had nothing to do with the test's safety or accuracy. Instead, the issue is that SCAN shares test results with individuals.
"SCAN's test is authorized by the Washington State Department of Health," SCAN said in a statement. "However, the [FDA] recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests."
"The FDA is supportive of at-home testing for COVID-19, provided there is data and science to support consumer safety and test accuracy. ... We had previously understood that SCAN was being conducted as a surveillance study," an FDA spokesperson told FOX Business. A surveillance study doesn't involve informing patients of results.
SCAN has been in conversation with the FDA since March 1 and hopes to have the EUA "soon," the group said in its statement.
Gates, who has been in the middle of discussions about how the world can fight coronavirus, said he was "excited" about SCAN in a blog post titled "Scanning for answers to a pandemic" last week, before the study was put on hold.
"I want to be clear that SCAN does not replace the widespread testing that is still needed in communities. But it has the potential to become an important tool for health officials seeking insights about the spread and behavior of the virus. Early results from SCAN found many cases of COVID-19 in Seattle that might otherwise have gone undetected," Gates wrote.