The U.S. FDA said it will exercise enforcement discretion for clinical labs operating in the state of New York that are deploying tests for the SARS-CoV-2 virus under the existing emergency use authorization (EUA). These labs, operated by the New York State Department of Health, will provide the FDA with validation data within 15 days of commencement of testing. The FDA also said it has added two models of the Cobas testing system by Roche Molecular Systems Inc., of Pleasanton, Calif., to the list of systems that can test for the SARS-CoV-2 virus under the existing EUA. The Cobas 6800 and 8800 systems are eligible for testing in labs certified for moderate and high complexity testing under CLIA and requires the use of authorized ancillary reagents as spelled out in the instructions for use. Jeff Shuren, director of the Center for Devices and Radiological Health, said that more than 30 labs have advised the agency that they have commenced with testing under the EUA.

No Comments