This article has been updated from a previous version to clarify language about the March 2020 authorization granted to kits supplied by LGC Biosearch.
NEW YORK — The US Food and Drug Administration on Thursday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by LGC Biosearch Technologies, a Petaluma, California-based division of UK-headquartered LGC.
The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test is designed to detect the N gene of the virus in samples collected by a healthcare provider, including anterior nasal, midturbinate nasal, nasopharyngeal, or oropharyngeal swabs, as well as nasopharyngeal washes/aspirates or nasal aspirates. It runs on LGC Biosearch's IntelliQube qPCR instrument.
The test may be used by any lab CLIA-certified to perform high-complexity tests, according to the FDA.
In March 2020, LGC Biosearch Technologies noted that it was supplying Emergency Use Authorized SARS-CoV-2 testing kits developed by the US Centers for Disease Control and Prevention.