The U.S. Food and Drug Administration (FDA) received two crucial actions in the agency’s continuing and aggressive dedication to addressing the coronavirus outbreak (COVID19).
Principally, the agency announced implementation discretion and is not complaining to the New York State Department of Health (NYSDOH) commissioning individual laboratories in New York to establish patient testing after confirming their tests and reporting to the NYSDOH. Under NYSDOH program, laboratories will present validation data to NYSDOH within 15 days, alternatively of seeking an Emergency Use Authorization (EUA) with the FDA.
The FDA Engagement
Secondary, the FDA approved the Roche Cobas SARS-CoV-2 Test, the third Emergency Use Authorization (EUA) allowed for a diagnostic test during the COVID-19 break.
“The activities now confirm our engagement in operating around the clock to assist the availability of tests. This NYSDOH performance dispenses the FDA’s total compliance and adaptability during times of public health crises,” 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 sufferer testing. Nor will they get an Emergency Use Authorization from the FDA. These labs will interact individually with NYSDOH, which should facilitate the availability of patient testing in New York State. This action demonstrates FDA’s responsiveness to the requirements of our country during this time.”
The FDA is giving this compliance to NYSDOH based on the urgent public health need for the new testing range. The FDA weighed several factors in this determination, 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 to be a third-party reviewer for specific molecular tests.
Additionally, the FDA announced a EUA to Roche Molecular Systems for its Cobas SARS-CoV-2 test within 24 hours of receiving the application. This is the first commercially issued diagnostic test to obtain a EUA during the COVID-19 outbreak.
Safety And Effectiveness
To facilitate access to this test, the FDA did not object to Roche pre-positioning its analysis so that labs could be equipped to initiate testing directly upon authorization of the EUA. Because of that pre-positioning, laboratories can immediately run tests on Roche’s high-volume platform, which will significantly improve national testing capacity.
“We have been helping test developers to come to the FDA and work with us,” stated Jeff Shuren, M.D., J.D., manager 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 advancement and validation of tests they plan to bring through the Emergency Use Authorization process. Besides, more than 30 laboratories have informed us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this crisis.”
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by encouraging the safety, effectiveness, and confidence of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the protection and security of our nation’s food supply, cosmetics, dietary additions, results that give off electronic radiation, and for regulating nicotine products.