Yesterday, the U.S. Food and Drug Administration took two significant actions in the agency’s ongoing and aggressive commitment to address the coronavirus outbreak (COVID19).
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. Under NYSDOH’s approach, laboratories will provide validation data to NYSDOH within 15 days in lieu of pursuing an Emergency Use Authorization (EUA) with the FDA.
Second, the FDA authorized the Roche Cobas SARS-CoV-2 Test, the third Emergency Use Authorization (EUA) granted for a diagnostic test during the COVID-19 outbreak.
“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 FDA Commissioner Stephen M. Hahn, M.D. “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. 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.”
The FDA is granting this flexibility to NYSDOH based on the urgent public health need for additional testing capacity. The FDA weighed several factors in this decision, including that the NYSDOH has a long-established framework in place for oversight of laboratory-developed tests in New York State. The FDA had also previously accredited Wadsworth be a third-party reviewer for certain molecular tests.
Additionally, the FDA issued an EUA to Roche Molecular Systems for its Cobas SARS-CoV-2 test within 24 hours of receiving the application. This is the first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak. To expedite access to this test, the FDA did not object to Roche pre-positioning its test so that labs could be ready to initiate testing immediately upon authorization of the EUA. Because of that pre-positioning, laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity.
“We have been encouraging test developers to come to the FDA and work with us,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Since the beginning of this outbreak, more than 60 developers have sought our assistance with the development and validation of tests they plan to bring through the Emergency Use Authorization process. 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.”
- Novel Coronavirus
- Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency – Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff
- Emergency Use Authorization