NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Premier Medical Laboratory Services' PCR-based SARS-CoV-2 assay.
The PMLS SARS-CoV-2 Assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens collected using the INeedaCOVID19Test.com Self Collection Kit.
Testing with the assay is limited to Greenville, South Carolina-based Premier Medical, according to the FDA.
In December 2020, Premier Medical partnered with TNG Dx to develop a rapid RNA extraction protocol for use with SARS-CoV-2 diagnostics.