The Bill Gates-backed at-home coronavirus testing program has been halted by the US Food and Drug Administration (FDA) because it began operation without getting proper authorization, according to the New York Times. The agency noted that they do not have any specific safety concerns about the product, but said that they still needed to do some research to ensure that the tests were safe.
The program in question is known as the Seattle Coronavirus Assessment Network (SCAN) and they are now being asked to put their operation on hold until proper authorization is obtained. This also means that patients who have already sent in their tests will not be able to receive their results until the authorization has been given. SCAN is promising that this shut down is only temporary.
SCAN’s website stated that, “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.”
SCAN was sending out free test kits to potential patients, including people who were asymptomatic, hoping to obtain some data on how the coronavirus spreads through people who don’t show symptoms.
In a statement announcing the finer details of the program last week, Gates said that, “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.”
However, an FDA shut down order came within days of the announcement, and the details behind the order are still unclear. The United States has been slow to get started with mass testing, especially of asymptomatic individuals, and the tests are mostly controlled by government agencies like the CDC. The tests currently available have also been criticized for being inaccurate. Just last week, the FDA issued a warning about tests made by Abbott Laboratories, saying that they often gave falsely negative results.
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