Quidel, San Diego, has received FDA emergency use authorization (EUA) to market its Lyra SARS-CoV-2 assay, 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 covid-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.
“Emergency use authorization for our Lyra SARS-CoV-2 assay allows Quidel to join the global fight against the covid-19 outbreak by providing healthcare workers in highly complex laboratories with a fast, accurate tool to diagnose patients infected with the novel coronavirus. The feature benefits of the test system and the Lyra product will contribute substantially to our country’s efforts to fight this pandemic,” says Douglas Bryant, president and CEO of Quidel. “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.”
The Lyra SARS-CoV-2 assay is currently available for sale only in the United States.
For more information, visit Quidel.