QuidelOrtho Receives CLIA Waiver for Sofia® 2 SARS Antigen+ FIA
QuidelOrtho 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.
- QuidelOrtho 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.
- With 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.
- “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.