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FDA Grants EUAs to Coronavirus Tests From Orig3n, SDI, UNC

NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization (EUA) for three PCR-based tests for SARS-CoV-2 including ones developed by Orig3n, Specialty Diagnostic Laboratories (SDI), and the University of North Carolina (UNC) Medical Center.

Orig3n's Novel Coronavirus Test is designed to detect two regions in the SARS-CoV-2 nucleocapsid gene, as well as the N3 SARS-like coronaviruses gene, in upper respiratory specimens including oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swab specimens. RNA is isolated using the Omega Bio-Tek Mag-Bind Viral DNA/RNA 96 bead kit, and the test runs on Thermo Fisher's Applied Biosystems QuantStudio7 Flex instrument with QuantStudio Real-Time PCR software version 1.3.

SDI's SARS-CoV-2 assay is intended for the qualitative detection of a region in the SARS-CoV-2 ORF1a/b gene in nasopharyngeal or oropharyngeal swabs. It is used with AusDiagnostics' AusDx MT-Prep nucleic acid extraction system and Thermo Fisher's Applied Biosystems 7500 instrument with software version 2.0.5.

The UNC Health SARS-CoV-2 real-time RT-PCR test is designed to detect the viral envelope gene in respiratory specimens. It is used with either the BioMérieux EasyMag or Roche MagNAPure 24 nucleic acid extraction systems, and Thermo Fisher's Applied Biosystems Prism 7500 instrument.

All of the newly authorized tests are to be performed in the labs where they were developed, the FDA said.