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Quidel’s Sofia® SARS Antigen FIA Updates EUA Performance Data to 96.7% PPA Versus PCR; Product Supports U.S. Initiatives to Expand Access to COVID-19 Testing in Nursing Homes; Receives CE Mark for Use With Sofia® and Sofia® 2 Instruments
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 updated the performance data for its Sofia® SARS Antigen FIA test on its package insert to 96.7% using direct nasal swab specimens versus PCR as a result of further studies included in its amended Emergency Use Authorization (EUA) that were submitted to the U.S. Food and Drug Administration (FDA).\n\n\n“The majority of PCR tests, including our Lyra® assay, have been shown to be effective in diagnosing COVID-19 within a specific window of SARS-CoV-2 exposure, generally within 5 days after the onset of patient symptoms. Further studies have validated that our Sofia® SARS Antigen FIA offers sensitivity that is comparable to PCR within this 5-day window, providing healthcare workers with confidence in their ability to accurately diagnose their patients,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We expect that this test will continue to play a critical role as an effective first line of defense against COVID-19.”\n\n\nHealthcare professionals can purchase the Sofia® SARS Antigen FIA in the United States through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, McKesson, or Medline.\n\n\nSofia® SARS Antigen FIA in Nursing Homes\n\n\nThe U.S. Department of Health and Human Services (HHS) has indicated its intent to purchase both Sofia® 2 instruments and the Sofia® SARS Antigen FIA for distribution and use in nursing homes. Under the proposed terms, HHS will purchase 2,000 Sofia® instruments and 750,000 Sofia® SARS Antigen FIA tests over the next few months to expand access to COVID-19 testing in nursing homes throughout the U.S.\n\n\nSofia® SARS Antigen FIA Receives CE Mark\n\n\nSeparately, the Sofia® SARS Antigen FIA received CE Mark for use with the Sofia® and Sofia® 2 instruments. The CE Mark allows Quidel to market and sell the Sofia® SARS Antigen FIA in Europe, as well as other countries that accept the CE Mark.\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 e...