The FDA has issued an unprecedented new guidance that allows individual states to approve diagnostic tests for COVID-19. The guidance also describes a policy regarding the use of serological testing for antibodies to the virus without an emergency use authorization (EUA).
The new guidance allows commercial manufacturers to more rapidly distribute their validated SARS-CoV-2 diagnostics to laboratories while the manufacturers are working on an EUA submission to the FDA. And it codifies the agency’s emergency use authorization policy instituted on Feb. 29, 2020.
The FDA said the guidance provides recommendations regarding the minimum testing that should be performed to ensure analytical and clinical validity. The agency will not object to the use of a test, without a new or amended EUA, where the test is validated using a bridging study to an EUA-authorized test. One way to bridge to a new component is to establish equivalent performance between parallel testing of the same specimens with the new and original components.
“In the context of a public health emergency involving pandemic infectious disease, it is critically
important that tests are validated as false results can have broad public health impact beyond that
to the individual patient,” the agency said in announcing the guidance. “In this guidance, FDA provides recommendations regarding validation of COVID-19 tests (and) encourages test developers to discuss any alternative approaches to validation with FDA.”
States that are home to laboratories that have developed tests for the virus are now allowed to authorize the use of those tests and must take responsibility for COVID-19 testing by laboratories in those states, the agency said.
On March 12, the FDA agreed to let New York State Department of Health state officials to authorize laboratories in the state that have validated COVID-19 tests to perform those tests on the public.
You can download the guidance here.