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QuidelOrtho Receives CLIA Waiver for Sofia® 2 SARS Antigen+ FIA
SAN DIEGO--(BUSINESS WIRE)-- QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies
About this update from Quidelortho Corporation
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nQuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA. The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance through the FDA’s De Novo process and is now the first rapid antigen test also to receive CLIA waiver. The test is intended for prescription use only and can be used in CLIA-waived point-of-care settings.\n\n\nWith the CLIA waiver, the Sofia 2 SARS Antigen+ FIA is deemed to be so simple and at such low risk of error that it no longer requires administration by trained clinical laboratory personnel, opening broader use in virtually any point-of-care setting equipped with Sofia 2 instruments.\n\n\n“As the first company to introduce a rapid antigen test for COVID-19 when the FDA granted Emergency Use Authorization for the Sofia SARS Antigen FIA in May of 2020, and the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA, it is gratifying to also be the first to receive a full CLIA waiver for our Sofia 2 SARS Antigen+ FIA,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho. “In the world of in vitro diagnostics, this qualifies as a trifecta of innovation, advancement and accessibility. This CLIA waiver is further proof of QuidelOrtho’s commitment to product efficacy, ease and ergonomics that help customers reduce costs and speed workflows, ultimately delivering better patient care.”\n\n\nThe Sofia 2 analyzer utilizes QuidelOrtho’s proprietary fluorescent chemistry design, intuitive graphical user interface, and optics system to provide an accurate, objective and automated result in just 10 minutes, a 33% reduction from the breakthrough 15-minute processing time achieved in the first iterations of the Sofia SARS Antigen FIA assay. The Sofia 2 system also comes connected to Virena®, QuidelOrtho’s data management system, which provides aggregated, de-identified testing and surveillance data in near real time.\n\n\nThe enhanced Sofia 2 SARS Antigen+ FIA Test kit includes other upgraded features, such as ...