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FDA Grants Emergency Use Authorization for Biocerna Coronavirus Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization (EUA) for Biocerna's PCR-based SARS-CoV-2 assay.

The assay is a modified version of Thermo Fisher Scientific's TaqPath COVID-19 SARS-CoV-2 Test, which received EUA last month. It is designed to detect the Orf1ab, N gene, and S gene regions of the SARS-CoV-2 genome using nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab and bronchoalveolar lavage specimens.

RNA extraction is performed using Thermo Fisher's Applied Biosystems MagMax Viral/Pathogen Nucleic acid isolation kit automated on the company' KingFisher Flex Purification system. RT-PCR is performed on the Applied Biosystems QuantStudio 5 real-time PCR system, and data is analyzed and interpreted by Applied Biosystems Design and Analysis Software version 2.3.3.

Use of the test is limited to Fulton, Maryland-based Biocerna.