Quidel’s Sofia® SARS Antigen Test Receives Emergency Use Authorization for Screening Use With Serial Testing

The Sofia® SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, delivering confidence to physicians, healthcare workers and other customers within the professional segment. This new intended use allows the Sofia® SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.¹ As with all antigen tests, performance may decrease as days since symptom onset increases due to lower viral loads later in the patient’s disease course. Similarly, the inability to synchronize asymptomatic individuals with onset of infection may impact performance as specimens may be tested when viral loads are below the assay’s limit of detection. Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance.

“Quidel’s goal throughout this pandemic has been to develop the most innovative and sensitive testing technologies on the market and to make our COVID-19 tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “FDA’s authorization opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.”

The Sofia® SARS Antigen FIA is only for use under the Food and Drug Administration’s Emergency Use Authorization. The Sofia® SARS Antigen FIA has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

1. https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2

About Quidel Corporation

Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names Sofia^®, Solana^®, Lyra^®, Triage^® and QuickVue^®, Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com.

View our story told by our people at www.quidel.com/ourstory.

Forward-Looking Statements

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