The Food and Drug Administration (FDA) halted, a minimum of temporarily, a Seattle-based at-home coronavirus testing program backed by 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) during a memo, consistent with The ny Times.
“The FDA has not raised any concerns regarding the security and accuracy of SCAN’s test, but we’ve been asked to pause testing until we receive that additional authorization,” consistent with an update on the SCAN website. There are currently only a few of at-home coronavirus tests with FDA authorization.
SCAN, which involved variety 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 check people both with and without symptoms to urge a way of how widespread COVID-19 is within the Seattle area. The FDA requires any coronavirus tests to receive an emergency use authorization (EUA) before getting used . Gates announced the program on Tuesday, May 13, and therefore the FDA sent the memo asking SCAN to pause on Wednesday.
“As SCAN gathers more test leads to the weeks ahead, researchers expect the new data to supply a far better sense of the amount of infections and function one source to assist answer other questions, like when physical distancing measures are often relaxed,” Gates wrote on his blog.
The test kits included a nasal swab that participants would then return to at least one of the institutions involved within the program. they might be ready to see the results of their test during a few days. SCAN would track results and demographic data — including age, gender, race, and postcode — to find out more about which members of the population are most in danger and to assess how social distancing measures are working. The program said it had the capacity to research 1,000 tests each day.
Testing for COVID-19 has been slow to urge up and running within us for a variety of reasons. It’s not clear how quickly the SCAN program could receive a EUA and obtain back to testing.
