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FDA Grants EUAs for Coronavirus Tests From Hologic, Genetworx, PacificDx

NEW YORK — The US Food and Drug Administration has issued separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Hologic, Genetworx and PacificDx.

Hologic's Aptima SARS-CoV-2/Flu assay is an automated multiplexed target nucleic acid amplification test intended for the simultaneous detection and differentiation of RNA from SARS-CoV-2, influenza A, and/or influenza B in nasopharyngeal, nasal, and mid-turbinate swab specimens.

The test is performed on San Diego-based Hologic's automated Panther system and can be run by any lab CLIA-certified to perform high-complexity tests, the FDA said.

The Genetworx Covid-19 Nasal Swab Test is designed to detect SARS-CoV-2 nucleic acid in nasal swab specimens self-collected using materials included in the test kit. Samples are mailed to Genetworx's Glen Allen, Virgina-based laboratory where they are tested using Hologic's authorized Aptima SARS-CoV-2 assay.

The PacificDx Covid-19 Test is designed to detect SARS-CoV-2 nucleic acid in upper respiratory specimens collected by a healthcare provider or in nasal swab specimens self-collected in a healthcare setting. It may also be used with nasal swab specimens self-collected at home using RapidRona's authorized self-collection kit.

The test is based on the US Centers for Disease Control and Prevention's 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel, which first received EUA from the FDA in February. It may be performed only by Irvine, California-based PacificDx, according to the FDA.

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