MicroGEM’s COVID-19 Saliva Test Gets FDA’s Emergency Use Authorization

MicroGEM U.S. has received an Emergency Use Authorization from the FDA for its MicroGEM Sal6830 SARS-CoV-2 saliva test for COVID-19.

The assay is authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens from individuals suspected by a healthcare provider of COVID-19 infection.

Processing of the samples is restricted to laboratories that are authorized to perform high, moderate or waived complexity tests — that is, tests approved for waiver under the Clinical Laboratory Improvement Amendments (CLIA) criteria.

MicroGEM’s headquarters are in Southampton, UK, and it has a U.S. office in Charlottesville, Va.