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FDA Grants Emergency Use Authorization for PreciGenome, PlexBio Coronavirus Tests

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.

Both tests are authorized for use by any laboratory CLIA certified to perform high-complexity tests.

In May, PlexBio, a Taiwan-based diagnostics developer, said its SARS-CoV-2 test received CE marking.