March 18, 2020—Quidel has received emergency use authorization from the FDA 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.
“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,” Douglas Bryant, president and CEO of Quidel, said in a press release. “Anticipating significant demand, we are allocating kits across a broad set of customers as we ramp production.”
The Lyra product line offers PCR reagent kits for use by molecular diagnostic laboratories with existing molecular testing infrastructure such as the Applied Biosystems 7500 Fast DX instruments. The Lyra SARS-CoV-2 Assay is only available for sale in the United States and can be purchased through Quidel or Cardinal Health.