The Food and Drug Administration (FDA) announced an updated policy related to diagnostic testing for coronavirus (COVID-19) in order to increase testing capabilities in the United States.
Similar to the action taken in New York State, states will be responsible for the tests developed and used by laboratories in their states. Rather than engaging with the FDA, labs will work directly with state authorities who will be responsible for authorizing these tests.
In addition, under certain circumstances, the agency will not object to manufacturers distributing new commercially developed tests or labs using these tests prior to the FDA granting an Emergency Use Authorization (EUA). “During this public health emergency, the FDA does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website,” FDA Commissioner Stephen M. Hahn MD stated in a press announcement.
Recommendations were also added regarding the development of serological tests. The FDA does not object to the use of these tests to identify antibodies for SARS-CoV-2 as long as the test has been validated, notification is provided to the agency, and warning statements (ie, this test should not be used as the sole basis for diagnosis or exclusion of SARS-CoV-2) are included with the test.
On the heels of the policy announcement, the FDA also issued EUAs to Hologic for its Panther Fusion® SARS-CoV-2 Assay and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
Additionally, Roche announced that it has begun shipping the first allotment of its cobas® SARS-CoV-2 Test to hospitals and labs across the US. An initial 400,000 tests will be shipped this week with an additional 400,000 tests per week expected thereafter.
For more information visit fda.gov.