FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic | FDA

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic | FDA

Emergency Use Authorization (EUA) updates

February 4, 2020: FDA authorized emergency use of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, a real-time RT-PCR test for the presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens collected from individuals who meet CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high-complexity tests. To date, this test has been limited to use at CDC laboratories; this authorization allows the use of the test at any CDC-qualified lab across the country. Additional technical information and fact sheets - Also see, from CDC: Information for Laboratories Diagnostic test developers interested in potential EUA for tests to detect 2019-nCoV should contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates.