The US Food and Drug Administration (FDA) announced today in a press release 2 significant actions it is taking to combat the coronavirus disease 2019 (COVID-19) outbreak that has infected >1600 people in the US so far.
First, the agency issued enforcement discretion and is not objecting to the New York State Department of Health (NYSDOH) authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the NYSDOH.
The FDA cited the urgent public health need for additional testing capacity as the reason for granting this flexibility to the NYSDOH.
Under this approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an Emergency Use Authorization (EUA) with FDA.
“As a practical matter, what this action means is that labs, authorized by NYSDOH, will not engage with FDA to begin patient testing. Nor will they get an Emergency Use Authorization from the FDA,” said FDA Commissioner Stephen M. Hahn, MD, in the press release. “These labs will interact solely with NYSDOH, which should expedite the availability of patient testing in New York State. This action demonstrates FDA’s responsiveness to the needs of our country during this time.”
Second, the FDA has issued an EUA to Roche Molecular Systems for its cobas SARS-CoV-2 test just 24 hours after receiving the application, making it the first commercially distributed diagnostic test to receive this authorization during the COVID-19 outbreak.
To expedite access to this test, the FDA did not object to Roche pre-positioning its test so that laboratories could be ready to start testing immediately upon authorization of the EUA. Due to that pre-positioning, laboratories can run tests immediately on Roche’s high-volume platform, which will significantly increase national testing capacity.
“These actions today show our commitment to working around the clock to help expedite the availability of tests. This NYSDOH action shows the FDA’s extreme flexibility and adaptability during times of public health emergencies,” said Hahn.
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