The FDA granted emergency use authorization to Quidel for the company’s Lyra SARS-CoV-2 assay, a real-time test designed to detect the COVID-19 nucleic acid in nasopharyngeal or oropharyngeal swab specimens from potentially infected patients.
“Emergency Use Authorization for our Lyra SARS-CoV-2 Assay allows Quidel to join the global fight against the COVID-19 outbreak by providing health care workers in highly complex laboratories with a fast, accurate tool to diagnose patients infected with the novel coronavirus,” Douglas Bryant, president and CEO of Quidel, said in a company press release.
“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,” Quidel continued. “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 only available for sale in the U.S. through Quidel or Cardinal Health. Testing with the new assay is limited to certified laboratories.
Quidel also manufactures point-of-care tests InflammaDry and QuickVue Adenoviral Conjunctivitis Test in the ophthalmic community.