\nThe Sofia\u00ae 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\u00ae 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<\/a>.1 <\/sup>As with all antigen tests, performance may decrease as days since symptom onset increases due to lower viral loads later in the patient\u2019s 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\u2019s limit of detection. Clinical studies in asymptomatic patients undergoing serial testing are ongoing to establish the clinical performance.\n<\/p>\n \n\u201cQuidel\u2019s 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,\u201d said Douglas Bryant, president and CEO of Quidel Corporation. \u201cFDA\u2019s 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\u00ae rapid antigen test for COVID-19 screening will catch asymptomatic cases early and limit virus spread.\u201d\n<\/p>\n The Sofia\u00ae SARS Antigen FIA is only for use under the Food and Drug Administration\u2019s Emergency Use Authorization. The Sofia\u00ae 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. \u00a7 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.<\/i><\/p>\n About Quidel Corporation<\/b><\/p>\n \nQuidel 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\u00ae<\/sup>, Solana\u00ae<\/sup>, Lyra\u00ae<\/sup>, Triage\u00ae<\/sup> and QuickVue\u00ae<\/sup>, Quidel\u2019s 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\u2019s 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<\/a>.\n<\/p>\n \nView our story<\/i> told by our people<\/i> at www.quidel.com\/ourstory<\/a>.\n<\/p>\n Forward-Looking Statements<\/b><\/p>\n This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation: the impact and duration of the COVID-19 global pandemic; competition from other providers of diagnostic products; our ability to accurately forecast demand for our products and products in development, including in new market segments; our ability to develop new technologies, products and markets and to commercialize new products; our reliance on sales of our COVID-19 and influenza diagnostic tests; our reliance on a limited number of key distributors; quantity of our product in our distributors\u2019 inventory or distribution channels; changes in the buying patterns of our distributors; the financial soundness of our customers and suppliers; lower than anticipated market penetration of our products; third-party reimbursement policies and potential cost constraints; our ability to meet demand for our products; interruptions, delays or shortages in the supply of raw materials, components and other products and services; failures in our information technology and storage systems; our exposure to data corruption, cyber-based attacks, security breaches and privacy violations; international risks, including but not limited to, economic, political and regulatory risks; continuing worldwide political and social uncertainty; our development, acquisition and protection of proprietary technology rights; intellectual property risks, including but not limited to, infringement litigation; the loss of Emergency Use Authorizations for our COVID-19 products and failures or delays in receipt of reviews or regulatory approvals, clearances or authorizations for new products or related to currently-marketed products by the U.S. Food and Drug Administration (the \u201cFDA\u201d) or other regulatory authorities or loss of any previously received regulatory approvals, clearances or authorizations or other adverse actions by regulatory authorities; our contracts with government entities involve future funding, compliance and possible sanctions risks; product defects; changes in government policies and regulations and compliance risks related thereto; our ability to manage our growth strategy and successfully identify, acquire and integrate potential acquisition targets or technologies and our ability to obtain financing; our acquisition of Alere\u2019s Triage\u00ae business presents certain risks to our business and operations; the level of our deferred payment obligations; our exposure to claims and litigation that could result in significant expenses and could ultimately result in an unfavorable outcome for us, including the ongoing litigation between us and Beckman Coulter, Inc.; we may need to raise additional funds to finance our future capital or operating needs; our debt, deferred and contingent payment obligations; competition for and loss of management and key personnel; business risks not covered by insurance; changes in tax rates and exposure to additional tax liabilities or assessments; and provisions in our charter documents and Delaware law that might delay or impede stockholder actions with respect to business combinations or similar transactions. Forward-looking statements typically are identified by the use of terms such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cmight,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cplan,\u201d \u201cintend,\u201d \u201cgoal,\u201d \u201cproject,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d and similar words, although some forward-looking statements are expressed differently. The risks described in reports and registration statements that we file with the Securities and Exchange Commission from time to time, should be carefully considered, including those discussed in Item 1A, \u201cRisk Factors\u201d and elsewhere in our Annual Report on Form 10 K for the year ended December 31, 2020 and in our subsequent Quarterly Reports on Form 10 Q. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management\u2019s analysis only as of the date of this press release. Except as required by law, we undertake no obligation to publicly release any revision or update of these forward-looking statements, whether as a result of new information, future events or otherwise.<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210401005968\/en\/<\/a><\/span><\/p>\n \nQuidel Contact: \nInvestors Contact: KEYWORDS:<\/b> United States North America California<\/p>\n INDUSTRY KEYWORDS:<\/b> Biotechnology Health FDA Medical Devices Data Management Infectious Diseases Technology Clinical Trials<\/p>\n\n
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Quidel Corporation
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Randy Steward
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Chief Financial Officer
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(858) 552-7931\n<\/p>\n
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Quidel Corporation
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Ruben Argueta
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(858) 646-8023
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rargueta@quidel.com<\/a><\/p>\n
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