Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorization for LabGenomics Coronavirus Test Kit

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for LabGenomics' PCR-based SARS-CoV-2 test kit.

The LabGun COVID-19 RT-PCR Kit is designed to detect the RdRp and E genes of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens and sputum. RNA extraction is performed using Qiagen's QIAamp Viral RNA Mini kit, and the test runs on either Thermo Fisher Scientific's Applied Biosystems 7500 Real-time PCR system or BioRad's CFX96 Real-time PCR detection system.

The test may be used by any lab CLIA certified to perform high-complexity tests, according to the FDA.

In late April, Maryland announced that it had acquired 500,000 SARS-CoV-2 tests from Seoul, Korea-based LabGenomics.