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FDA Grants Emergency Use Authorization for Premier Medical COVID-19 Test

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 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.