Quidel’s Lyra SARS-CoV-2 Secures Expanded Use Authorization from US FDA

Quidel Corporation (San Diego, CA, USA) has received expanded Emergency Use Authorization (EUA) claims from the Food and Drug Administration (FDA) to allow testing for its Lyra SARS-CoV-2 Assay on three additional thermocyclers, namely Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.1 Quidel had recently received EUA from the FDA to market 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. The list of acceptable specimens has been expanded by the CDC to include nasal and nasal turbinate swabs
Quidel, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, develops diagnostic solutions which aid in the detection and diagnosis of several critical diseases and conditions, including influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel’s Lyra real-time PCR assays are an open platform solution for high throughput, high quality molecular testing to detect and identify infectious diseases. Lyra PCR assays are focused on optimizing a lab's workflow to make these tests simple and easily implemented with minimal steps, easy refrigerated storage, room temperature procedures and flexible instrumentation.

The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The Assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus. The rest results are available in less than 75 minutes after extraction. The earlier EUA from the FDA had authorized testing for the Lyra SARS-CoV-2 Assay on the bioMerieux NucliSENS easyMAG system or EMAG system, followed by RT-PCR on the FDA-cleared Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. The Lyra SARS-CoV-2 Assay has also received CE-Mark which allows Quidel to market and sell the product in Europe, as well as in other countries that accept the CE Mark.

The feature benefits of the test system and the Lyra product will contribute substantially to our country’s efforts to fight this pandemic,” said 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.”

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