FDA Grants Emergency Use Authorization for PreciGenome, PlexBio Coronavirus Tests

2020.06.29

NEW YORK — The US Food and Drug Administration on Thursday issued separate Emergency Use Authorizations for SARS-CoV-2 tests developed by PreciGenome and PlexBio.


PreciGenome's FastPlex Triplex SARS-CoV-2 Detection Kit is designed to detect the virus' ORF1ab and N genes in oropharyngeal swabs. Nucleic acid extraction is performed using Qiagen's QIAamp Viral RNA Mini Kit and the test runs on RainSure Scientific's DropX-2000 Digital PCR System.

Precigenome is a San Jose, California-based developer of microfluidics technologies.


PlexBio's IntelliPlex SARS-CoV-2 Detection Kit is designed to detect the virus' E, N, and RdRp genes in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates and bronchoalveolar lavage specimens. It uses the QIAamp Viral RNA Mini Kit for nucleic acid extraction and runs on PlexBio's IntelliPlex platform.


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