Quidel 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)

The 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.

Under 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

In 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.


Source: Company Press Release