Quidel Corp (QDEL) Receives Amended EUA for New Sofia Q Rapid Antigen Test Device

June 11, 2021 4:12 PM EDT

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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 an amended Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) allowing the company to market Sofia® Q, its latest addition to the Sofia® and Sofia® 2 line of Fluorescent Immunoassay Analyzers (FIA). Sofia Q features a sleek, miniaturized design that reads the same Sofia® SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy. Sales of Sofia Q device will initially be limited to use with the Sofia® SARS Antigen FIA in the CLIA and CLIA-waived professional segments.

Sofia Q is the latest product in Quidel’s best-selling Sofia instrumentation portfolio. Sofia Q utilizes Sofia® fluorescent technology to provide an accurate, objective, and automated result in 15 minutes. Quidel’s innovative design allows the Sofia Q device to be paired with the downloadable Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model.

“Sofia Q is our latest powerful diagnostic instrument designed to democratize access to the many benefits of our Sofia SARS rapid antigen tests and, ultimately, our full portfolio of Sofia tests for influenza, RSV, Strep and other conditions,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace. In the future, we believe Sofia Q will be ideal to serve consumers at home, as well as in schools and workplaces.”

In addition to the Sofia Q, Quidel offers other rapid diagnostic instrumented systems, including Sofia 2, and Sofia. Quidel’s Sofia assays for rapid antigen COVID-19 diagnosis include Sofia® 2 SARS Antigen FIA and Sofia® 2 Flu + SARS Antigen FIA, currently under EUA by the FDA. Quidel offers other FDA-cleared and CLIA-waived tests including Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia tests for Lyme Disease, Legionella and S. pneumoniae in Europe.



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