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Quidel Corporation Applauds Biden Administration Plan to Expand COVID-19 Testing

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Quidel Corporation (NASDAQ: QDEL) has expressed support for the Biden Administration's initiative to enhance COVID-19 testing across various communities. The company emphasizes the importance of frequent testing in safely reopening schools and institutions. Quidel recently received Emergency Use Authorization for its QuickVue® At-Home COVID-19 Test, aiming to expand access to testing without prescriptions. Additionally, the company is constructing a new 128,000 square foot manufacturing facility in Carlsbad, CA, expected to produce 600 million rapid antigen tests annually.

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  • Support for Biden Administration's COVID-19 testing expansion.
  • Emergency Use Authorization granted for QuickVue® At-Home COVID-19 Test.
  • Construction of a new manufacturing facility to produce 600 million tests annually.
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  • None.

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced its support for the Biden Administration’s plan to expand COVID-19 testing in schools, underserved communities, rural areas and other settings that have been gravely impacted by the pandemic.

“Quidel applauds the Biden Administration’s urgent and comprehensive approach to bringing the benefits of rapid, routine and equitable coronavirus testing to America’s classrooms, underserved communities and rural areas,” said Douglas Bryant, president and CEO of Quidel Corporation. “Frequent testing has proven to be a critical tool for both empowering people to take charge of their own health and allowing large institutions, businesses, sports and entertainment venues and enumerable other aspects of society to reopen safely and remain so.”

“Our mission at Quidel has always been to democratize access to frequent, affordable and highly accurate COVID-19 testing, and we expect the Administration’s American Rescue Plan for testing will turbocharge efforts all across the diagnostics industry to get everyone screened so the virus and any variants can be stopped, tracked and traced in real time,” Mr. Bryant noted. “We are approaching the inflection point where frequent at-home, in-school and on-site testing of asymptomatic people at scale can give us greater peace of mind to see our families, dine out and travel.”

Quidel recently received Emergency Use Authorization (EUA) from the FDA for its QuickVue® At-Home COVID-19 Test, an easy-to-use test that provides results to symptomatic patients in ten minutes with a doctor’s prescription. The company is seeking an EUA for over-the-counter (OTC) sale of the QuickVue® At-Home COVID-19 Test to symptomatic and asymptomatic consumers without a prescription. Quidel is currently building out a new manufacturing facility in Carlsbad, CA dedicated to the production of Quidel’s popular QuickVue® line of products. The 128,000 square foot facility will be the company’s highest-volume production plant in the world and is expected to produce 600 million QuickVue® rapid antigen tests for the detection and diagnosis of COVID-19 infections.

Visit www.quickvueathome.com for more information.

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

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’ 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 “FDA”) 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’s Triage® 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 “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” 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, “Risk Factors” 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’s 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.

FAQ

What is Quidel Corporation's role in COVID-19 testing?

Quidel Corporation supports the Biden Administration's initiative to expand COVID-19 testing in schools and underserved communities.

What recent authorization did Quidel receive for its COVID-19 test?

Quidel received Emergency Use Authorization for its QuickVue® At-Home COVID-19 Test.

How many tests will Quidel's new manufacturing facility produce?

The new manufacturing facility in Carlsbad, CA, is expected to produce 600 million QuickVue® rapid antigen tests annually.

What is the significance of frequent COVID-19 testing according to Quidel?

Frequent testing is crucial for safely reopening schools and institutions and empowering individuals to manage their health.

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