FDA issues EUA for Quidel’s molecular COVID-19 diagnostic assay

March 19, 2020

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to San Diego, CA-based Quidel for its diagnostic assay to detect SARS-CoV-2, the virus that causes COVID-19, the company announced in a news release.

Quidel’s Lyra SARS-CoV-2 assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of being infected with COVID-19 by their healthcare provider. Testing using the product is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, the company said.

Quidel is one of numerous companies in recent weeks that have received EUAs, allowing them to market diagnostic assays to detect the novel coronavirus. Quidel’s SARS-CoV-2 test is currently only available for sale in the United States, the company said.

“We are proud to have quickly developed this assay in mere weeks, and to have manufactured kits, several of which are in transit to customers. Anticipating significant demand, we are allocating kits across a broad set of customers as we ramp production,” said Douglas Bryant, president and CEO of Quidel.

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