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FDA Grants Emergency Use Authorization for Columbia University Coronavirus Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed at Columbia University.

The Triplex CII-SARS-CoV-2 rRT-PCR test is designed to detect the SARS-CoV-2 nucleocapsid gene in nasopharyngeal, oropharyngeal, nasal, and midturbinate nasal swab samples. It uses the BioMérieux easyMAG automated extraction platform using the NucliSENS easyMAG extraction kit and Thermo Fisher Scientific's Applied Biosystem 7500 Fast Dx Real-Time PCR Instrument with software version 2.3.

The FDA said the test may only be performed at the Columbia University Laboratory of Personalized Genomic Medicine.