The Food and Drug Administration (FDA) halted, at least temporarily, a Seattle-based at-home coronavirus testing program backed by Bill Gates.
“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the FDA told the Seattle Coronavirus Assessment Network (SCAN) in a memo, according to The New York Times.
“The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization,” according to an update on the SCAN website. There are currently only a couple of at-home coronavirus tests with FDA authorization.
SCAN, which involved a number of institutions, including the University of Washington Medicine and backed by The Bill and Melinda Gates Foundation, was sending free test kits to participants.
The goal was to test people both with and without symptoms to get a sense of how widespread COVID-19 is in the Seattle area. The FDA requires any coronavirus tests to receive an emergency use authorization (EUA) before being used. Gates announced the program on Tuesday, May 13, and the FDA sent the memo asking SCAN to pause on Wednesday.
“As SCAN gathers more test results in the weeks ahead, researchers expect the new data to provide a better sense of the number of infections and serve as one source to help answer other questions, like when physical distancing measures can be relaxed,” Gates wrote on his blog.
The test kits included a nasal swab that participants would then return to one of the institutions involved in the program. They would be able to see the results of their test in a couple of days. SCAN would track results and demographic data — including age, gender, race, and ZIP code — to learn more about which members of the population are most at risk and to assess how social distancing measures are working. The program said it had the capacity to analyze 1,000 tests a day.
Testing for COVID-19 has been slow to get up and running in the United States for a number of reasons. It’s not clear how quickly the SCAN program could receive an EUA and get back to testing.
