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Quidel’s Lyra® SARS-CoV-2 Assay Receives Authorization for Expanded Use for Molecular Detection of COVID-19; Also Receives CE Mark, Health Canada Authorization
SAN DIEGO--(BUSINESS WIRE)-- Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays
About this update from Quidelortho Corporation
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nQuidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel’s Lyra® SARS-CoV-2 Assay has received expanded Emergency Use Authorization (EUA) claims from the Food and Drug Administration (FDA) to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q.1 \n\n\nAcceptable Specimens Expanded to Include Nasal and Nasal Turbinate Swabs \n\n\nUnder the initial EUA, the Lyra® SARS-CoV-2 Assay real-time RT-PCR test was 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. The list of acceptable specimens has been expanded by the CDC to include nasal and nasal turbinate swabs. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. EUAs allow for the early availability of important diagnostic tools “when there are no adequate, approved and available alternatives.”2 \n\n\nThe Lyra® reagents include unique features that provide for simple transport and storage, improved workflow, shorter time to result, and other benefits that favorably affect diagnostic test outcome. The Lyra SARS-CoV-2 Assay provides these and certain additional advantages over many other tests currently on the market for this novel coronavirus, including easier set-up and faster time to result.\n\n\nQuidel Receives CE Mark, Health Canada Authorization \n\n\nSeparately, the Lyra® SARS-CoV-2 Assay received CE-Mark on March 25, 2020. The CE Mark allows Quidel to market and sell the Lyra® SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark. Also, on March 25, 2020, Quidel received authorization from Health Canada to market and sell the assay in Canada. The assay is currently available for sale in the United States under EUA and can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.\n\n\nAbout Quidel Corporation\n\n\nQuidel Corporation serves to enhance the health and well-being of people around the globe through the ...