The Food and Drug Administration (FDA) issued new flexibilities to the New York State Department of Health (NYSDOH) to address the coronavirus (COVID-19) outbreak and issued the third Emergency Use Authorization (EUA) diagnostic. FDA Commissioner Stephen Hahn stated that these actions demonstrate the agency’s commitment to expedite the availability of tests.
The FDA issued enforcement discretion and is not objecting the NYSDOH from authorizing certain laboratories in New York to begin patient testing after validating their tests and notifying the department. This will allow New York laboratories to submit validation to the NYSDOH, in lieu of requesting an EUA with the FDA. The agency notes this action expedite the availability of tests and increase overall testing capacity in New York.
Additionally, the FDA authorized the Roche cobas SARS-COV-2 test, the third EUA granted for a diagnostic test during the COVID-19 outbreak. The agency notes that this is the first commercially distributed diagnostic test to receive an EUA. In order to expedite access to the test, the FDA did not object Roche to pre-positioning so that labs can immediately run tests on Roche’s high volume platform. The agency states this action will “greatly increase national testing capacity.”