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Quidel’s Lyra® Direct SARS-CoV-2 Assay Receives Emergency Use Authorization and CE Mark for Molecular Detection of COVID-19, Without Extraction Step
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 has received Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing.\n\n\nLyra® Direct Removes RNA Extraction Processing Step, Removes Supply Bottleneck \n\n\nUnder the new EUA, the Lyra® Direct SARS-CoV-2 Assay no longer requires an up-front sample extraction. The Lyra® Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay retains its versatility in that it is capable of running on any of seven possible thermocyclers (Applied Biosystems 7500 Standard®, Applied Biosystems 7500 Fast®, Bio-Rad CFX96 Touch®, Qiagen Rotor-Gene Q®, Roche LightCycler® 480, Roche Cobas® z480, and Thermo Fisher QuantStudio 7 Pro®).1\n\n\nLyra® Direct Receives CE Mark\n\n\nSeparately, the Lyra® Direct SARS-CoV-2 Assay received CE Mark on May 8, 2020. The CE Mark allows Quidel to market and sell the Lyra® Direct SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark.\n\n\nThe assay is currently available for sale in the United States under EUA. The Lyra® Direct SARS-CoV-2 Assay can be purchased by laboratory professionals through Quidel directly, or through their Cardinal Health representative.\n\n\n\nApplied Biosystems®, CFX96 Touch®, Rotor-Gene Q®, LightCycler® 480, Cobas z480, and QuantStudio 7 Pro® are registered trademarks of their respective owners.\n\n\n\nAbout Quidel Corporation\n\n\nQuidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, lyme, herp...