The US Food and Drug Administration announced on Saturday a policy allowing certain US labs to test for the novel coronavirus using diagnostics the labs developed and validated, even before the agency has reviewed them.
The policy will enable more rapid testing capacity, the agency says.
“We believe this policy strikes the right balance during this public health emergency,” FDA Commissioner Dr. Stephen Hahn said in a statement. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the US.”
The guidance goes into effect immediately: Once labs have validated a test, they must notify the FDA and should submit a request for an emergency use authorization within 15 business days. This policy applies only to labs certified to perform high-complexity testing.
Local and state labs�� ability to test for the novel coronavirus was delayed because test kits previously developed by the US Centers for Disease Control were flawed.
The CDC said Friday that US labs were able to start testing for coronavirus using revised instructions for kits previously sent out. CDC also has manufactured brand new test kits that are available for order.
The CDC said its goal was for every state and local health department testing for coronavirus by the end of next week.