The US Food and Drug Administration (FDA) has relaxed the regulations around diagnostics for Covid-19 to expedite the availability of testing.
Tests developed and used by laboratories across the country can now be authorised by state Departments of Health without direct engagement from the FDA. The developers will not need to pursue an Emergency Use Authorisation (EUA) with the FDA to have their assays approved.
The FDA does not intend to object to commercial manufacturers distributing tests, or to labs using commercially developed tests prior to the granting of an EUA, under certain circumstances.
Numerous commercial manufacturers are known to be in the process of developing tests for Covid-19 with the intent to submit an EUA. The FDA does not intend to object to the distribution of these Covid-19 tests for specimen testing for 15 days between the manufacturer’s validation of the test and the granting of an EUA.
To be eligible for this non-objection the manufacturer will need to provide instructions for using the test and data about its performance on their website.
The FDA has also highlighted that it does not intend to object to the distribution and use of serologic Covid-19 tests, which identify antibodies to an infection rather than the infection itself. These are inherently less effective for diagnostic purposes, but their use will be permitted as long as serologic tests are validated, notification is provided to the FDA and warning statements are included with the test.
On 17 March, the administration issued EUAs to Hologic for its Panther Fusion SARS-COV-2 Assay and to Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
FDA commissioner of food and drugs Stephen Hahn said: “Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. We stand ready to continue to support medical products in the pipeline to fight this virus.”