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Quidel’s Lyra® Direct SARS-CoV-2 Assay Receives 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 has received Health Canada authorization to market and sell the Lyra® Direct SARS-CoV-2 Assay in Canada. (IO315563, COVID-19 Medical Device Authorization for Importation or Sale; 07/20/2020)\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\nLyra® Direct Does not require Extraction Processing Step, Removes Supply Bottleneck \n\n\nUnder the authorization, the Lyra® Direct SARS-CoV-2 Assay does not require an upfront sample extraction. The Lyra® Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces extraction with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay can run on any of seven possible thermocyclers (Applied Biosystems® 7500 Standard, Applied Biosystems® 7500 Fast Dx, Bio-Rad CFX96 Touch™, Qiagen Rotor-Gene® Q, Roche LightCycler® 480 Instrument II, Roche cobas® z 480, and Thermo Fisher QuantStudio™ 7 Pro).1\n\n\nIn addition to Canada, the assay is currently available for sale in the United States under EUA, and in Europe under CE Mark. The Lyra® Direct SARS-CoV-2 Assay can be purchased by laboratory professionals through the Quidel Canada Sales Team directly.\n\n\n_______________________\n\n\n\n\n1.\n\n\n\nApplied Biosystems is a registered trademark of Life Technologies. LightCycler and cobas z 480 are registered trademarks of Roche. Rotor-Gene Q is a registered trademark of Qiagen. CFX96 Touch is a trademark of Bio-Rad Laboratories, Inc. QuantStudio is a trademark of Applied Biosystems.\n\n\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®...