The Food and Drug Administration announced Friday it is allowing emergency use of a novel coronavirus testing system designed by Roche Molecular Systems “within 24 hours of receiving the application,” the agency said.
This is the first commercially distributed diagnostic test to receive an emergency use authorization during the COVID-19 outbreak, the FDA said.
“Laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity,” the agency said.
FDA also announced its allowing the New York State Department of Health to authorize some New York laboratories to test for the novel coronavirus after validating their tests. Generally, a lab would have to pursue emergency use authorization through the FDA
The FDA granted this flexibility based on the urgent public health need for additional testing capability, according to a statement.