FDA Relaxes Rules for Virus Diagnostic Tests

18.03.2020 -

Prompted by the recent surge in coronavirus cases, the US Food and Drug Administration has given the go-ahead for commercial testing and is now allowing companies to proceed with diagnostic tests without first submitting their kits for federal review or obtaining an official emergency clearance.

As of Mar. 17, the US had reported 4,600 corona infections, and epidemiologists estimate that the country is just days behind seeing large-scale spread of the virus similar to countries such as Italy, which by the same date had 28,000 infections.

FDA commissioner Stephen Hahn said “tens of companies” have already signed up to test for the virus under the agency’s new “unprecedented” policy. He said the FDA aims to expand the capacity as well as the variety of COVID-19 molecular diagnostics available and trusts companies and labs to make sure their tests are well-validated.

The new policy widens the scope of the health watchdog’s previous moves to accelerate testing, which had allowed certain government-certified labs to proceed with their own tests while submitting their data and emergency use application to the FDA for review within 15 days.

Commercial developers will be held to the same paperwork requirement, the FDA head said.

Health sector observers noted that the decision also represents a dramatic, if temporary, change in the FDA’s stance toward regulation of testing. In the past, it had warned of the personal health risks that could follow erroneous test results.

In the meantime, several diagnostic industry companies have completed the US Emergency Use Authorization (EUA) process for testing. The Along with Roche and Thermo Fisher, the list contains the names of other less well-known biotech firms.

The FDA is providing technical assistance to test providers. According to Hahn, 90 test developers have sought the agency’s guidance.