The agency said it will not object to the New York State Department of Health (NYSDOH) authorizing laboratories in the state to begin patient testing after validating in-house developed tests and notifying the department. The labs will provide proof of validation within 15 days of beginning to use the tests, instead of applying for an emergency use authorization (EUA) from the FDA.
In addition, the FDA issued an EUA to Roche Molecular Systems for its cobas SARS-CoV-2 test. The EUA was issued within 24 hours of receiving the application, the agency said.
"To expedite access to this test, FDA did not object to Roche [prepositioning] its test so that labs could be ready to initiate testing immediately upon authorization of the EUA," the agency said in its statement.
The FDA's actions come as the U.S. continues to grapple with the availability of tests for the virus. Some companies have had difficulty ramping up the production of kits, while a scarcity of RNA extraction kits has created a bottleneck in efforts to diagnose the illness. On February 29, the FDA issued guidance to allow labs to develop and use their own diagnostic tests for the virus before they have received an EUA from the agency.
"We have been encouraging test developers to come to the FDA and work with us," Dr. Jeff Shuren, director of the agency's Center for Devices and Radiological Health, said in the FDA's statement. "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 [EUA] 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."
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