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Quidel Nabs FDA Emergency Use Authorization for Coronavirus Assay

NEW YORK – Quidel said after the close of the market on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the firm's Lyra SARS-CoV-2 assay for the detection of the coronavirus that causes COVID-19.

The RT-qPCR test is for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of having the coronavirus.

San Diego-based Quidel noted that its Lyra product line offers PCR reagent kits that can be used by laboratories equipped with molecular testing instrumentation such as the Applied Biosystems 7500 Fast DX platforms from Thermo Fisher Scientific.

On Monday, FDA issued EUAs to Hologic and Laboratory Corporation of America, following similar authorizations to Thermo Fisher Scientific and Roche.