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FDA opens the gates to commercial coronavirus testing without agency review
by
Conor Hale |
Mar 17, 2020 10:00am

Tens of companies have already signed up to test coronavirus diagnostics under a new “unprecedented policy,” according to FDA Commissioner Stephen Hahn, who said the agency is, essentially, now trusting companies and labs to make sure their tests in the field are well-validated. (NIAID - Rocky Mountain Laboratories)
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In the face of urgent need, the FDA has opened its floodgates to commercial coronavirus testing. The agency is now allowing companies to proceed with their diagnostic tests without first submitting them for federal review or obtaining an official emergency clearance.


The move comes as epidemiologists estimate that the U.S. is just days behind seeing large-scale spread of the virus similar to what is currently happening in countries such as Italy—which as of March 17 has reported nearly 28,000 confirmed cases, the most outside of China, while the U.S. now stands at over 4,600 cases, according to international health authorities.

Tens of companies have already signed up to test under the new “unprecedented policy,” according to Commissioner Stephen Hahn, who said the FDA aims to expand the capacity as well as the variety of COVID-19 molecular diagnostics available—and that the agency is, essentially, trusting companies and labs to make sure their tests in the field are well-validated.