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QuidelOrtho Receives De Novo FDA Authorization 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 a De Novo request from the U.S. Food and Drug Administration (FDA), allowing the company to market 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. The test is intended for prescription use only and can be used in point-of-care settings.\n\nThe Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent assay that is used with the Sofia 2 fluorescent immunoassay analyzer intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within six days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests. The Sofia 2 SARS Antigen+ FIA is intended for use by trained clinical laboratory personnel and individuals trained in point-of-care settings and proficient in performing tests using Sofia 2 instruments.\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, we are pleased to again be the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA,” said Douglas Bryant, president and CEO of QuidelOrtho Corporation. “With this De Novo authorization, Sofia becomes the predicate device upon which subsequent devices of the same type and intended use will be compared. This designation is a tribute to the incredible ingenuity, commitment to quality, and cohesion of our entire QuidelOrtho team from R&D and regulatory affairs, to design, manufacturing, labeling and packaging. It is a spirit that sustained us through the darkest days of the pandemic and will assure that our rapid testing technologies remain at the forefront of prevention as COVID-19 transitions to its endemic stage.”\n\nThe Sofia 2 analyzer...