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Home » Business, Policy & Funding » Business News » FDA Grants EUAs for Coronavirus Tests From Hologic, Genetworx, PacificDx

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

Dec 17, 2020
|
staff reporter

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.

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