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Mayo Clinic Coronavirus Assay Gets Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for the Mayo Clinic's PCR-based SARS-CoV-2 diagnostic assay.

According to the FDA, the SARS-CoV-2 Molecular Detection Assay is designed to detect RNA from the virus' nucleocapsid and ORF1ab genes in upper and lower respiratory specimens including nasopharyngeal swabs, throat swabs, nasal swabs, sputum, and tracheal secretions.

RNA is isolated using BioMérieux's easyMAG and EMAG extraction instruments, and the test runs on Roche's LightCycler 480 version 1.5.1.62.

Assay testing is limited to the Mayo Clinic's CLIA-certified lab, the FDA said.