Quidel Corp. announced today, March 18, that the FDA granted the company Emergency Use Authorization (EUA) to market its Lyra SARS-CoV-2 Assay (Lyra), a real-time reverse transcription polymerase chain reaction (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 COVD-19, or coronavirus, by their healthcare provider, the company said in a press release on March 17.
Lyra benefits include easy setup and fast time to result, according to the company. The kits are for use by molecular diagnostic laboratories, with CLIA certification and existing molecular testing infrastructure.
The test is only available for sale in the US and can be purchased through Quidel’s salesforce or Cardinal Health.
Read the full release from Quidel here: http://bit.ly/2xJXjx2
Article
Quidel Receives Emergency Authorization for COVID-19 Test
FDA granted emergency approval to Lyra SARS-CoV-2 Assay
Ophthalmic Professional
March 18, 2020