The Food and Drug Administration (FDA) has announced that it will not object to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to start testing patients for coronavirus disease 2019 (COVID-19) once the tests have been validated.
Rather than pursuing an Emergency Use Authorization with the FDA, the labs will need to provide validation data to NYSDOH. “As a practical matter, what this action means is that labs, authorized by NYSDOH, will not engage with FDA to begin patient testing,” said FDA Commissioner Stephen M. Hahn, MD. “These labs will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State.”
In addition, under the Emergency Use Authorization, the FDA has authorized the Roche cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. The test can be run on Roche’s automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the US.
“Since the beginning of this outbreak, more than 60 developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory developed tests for this emergency.”