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Quidel Opens New Manufacturing Facility to Mass Produce QuickVue® Rapid Antigen Tests for COVID-19

02/03/2021

Carlsbad, CA facility aims to reach a run rate of 600 million QuickVue® tests per year by end of 2021

Future plans call for production of numerous popular QuickVue® diagnostic tests to serve the emerging at-home testing market

SAN DIEGO--(BUSINESS WIRE)-- Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, today announced the opening of a new manufacturing facility in Carlsbad, CA that will be 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 begins operations in the second half of 2021 with a mission to produce 600 million QuickVue® SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections.

Quidel plans to install multiple manufacturing lines at the Carlsbad facility and hire approximately 400 new employees with a mission to scale Quidel’s operations from 50 million QuickVue® tests per year to 50 million tests per month at full capacity, including non-COVID-19 diagnostic assays currently in-market or under development. The company is actively hiring to fill open positions including engineers, chemists, technicians, manufacturing, purchasing, sourcing and support services.

“From the first days of the pandemic, Quidel has stepped up to meet the COVID-19 challenge head-on with innovative diagnostic technologies to detect coronavirus infections and expanded manufacturing to democratize access to affordable and high-quality testing,” said Douglas Bryant, president and CEO of Quidel Corporation. “The opening of our massive new QuickVue® manufacturing plant is our boldest move yet and is expected to provide Quidel with the scale necessary to serve the needs of communities and institutions for frequent testing now and for years to come.”

Quidel received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QuickVue® SARS Antigen Test for COVID-19 in December. The company’s QuickVue® lateral-flow technology is visually read by the user and provides results in 10 minutes from nasal swab samples. Initial applications for QuickVue® COVID-19 tests range from hospitals and physician offices to schools and pharmacies. Quidel is seeking EUA for a new QuickVue® At-Home COVID-19 Test for over-the-counter sale directly to consumers.

Quidel’s new QuickVue® SARS Antigen test offers excellent performance for the detection of SARS-CoV-2, with positive results agreeing with PCR 96.6% of the time and negative results agreeing 99.3% of the time, thereby providing quick, reliable results to patients, their families and healthcare workers alike.

In the professional segment, Quidel has manufactured the QuickVue® line for over 30 years. Quidel was the first company to introduce a visually read flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. QuickVue® was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies.

Today, Quidel’s QuickVue® diagnostic products that test for Influenza, RSV, Strep A, fecal occult blood, pregnancy, chlamydia, infectious mononucleosis, adenoviral conjunctivitis and H. pylori. Over the years, more than 150 million QuickVue® diagnostic testing units have been sold.

To learn more about our available positions, please visit: https://careers.quidel.com/

Background Information:

Throughout this pandemic, Quidel has been at the forefront of diagnostic innovation. From the company’s Lyra® PCR tests, to its Sofia® rapid antigen tests for COVID-19, to its Sofia® “ABC” combination test for the Influenza A+B and coronavirus, to its QuickVue SARS-CoV-2 test authorized for emergency use by the FDA in December, Quidel has significantly advanced the science and the scale of its operations.

Quidel was the first company to receive EUA from the FDA for a rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against the coronavirus pandemic.

Sofia® 2 is Quidel’s best-selling cartridge-based, instrument-read rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real-time.

In 2020, Quidel quickly increased its production of Sofia® rapid antigen tests from approximately 500,000 units per week to a rate of over 2 million tests per week at the end of December. Quidel is building additional production lines with a goal to reach a run-rate of over 240 million Sofia® tests per year by the third quarter of 2021. In 2020, the company also increased the installed base of Sofia® diagnostic instruments to more than 65,000 point-of-care locations.

Quidel’s QuickVue® and Sofia® SARS Antigen test kits are made in the greater San Diego metropolitan area of California.

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 novel virus (COVID-19) global pandemic; funding and compliance risks relating to government contracts, including our ability to meet key deliverables and milestones under our NIH RADx-ATP contract; our ability to accurately forecast demand for our products and products in development, including in new market segments; adverse changes in competitive conditions; the reimbursement system currently in place and future changes to that system; changes in economic conditions in our domestic and international markets; lower than anticipated market penetration of our products; our reliance on sales of our influenza and COVID-19 diagnostic tests; fluctuations in our operating results resulting from the timing of the onset, length and severity of cold and flu seasons, seasonality, government and media attention focused on influenza and other respiratory or novel viruses and the related potential impact on humans from such viruses; our ability to meet demand for our products; interruptions, delays or shortages in the supply of raw materials, equipment and other components; the quantity of our product in our distributors’ inventory or distribution channels; changes in the buying patterns of our distributors; changes in the healthcare market and consolidation of our customer base; our development, acquisition and protection of proprietary technology rights; our ability to develop new technologies, products and markets and to commercialize new products; our reliance on a limited number of key distributors; 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.; intellectual property risks, including but not limited to, infringement litigation; our ability to finance our capital or operating needs; the financial soundness of our customers and suppliers; acceptance of our products among physicians and other healthcare providers; competition from other providers of diagnostic products; 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; changes in government policies; costs of and adverse operational impact from failure to comply with government regulations in addition to FDA regulations; compliance with government regulations relating to the handling, storage and disposal of hazardous substances; third-party reimbursement policies and potential cost constraints; our failure to comply with laws and regulations relating to billing and payment for healthcare services; product defects; business risks not covered by insurance; costs and disruptions from failures in our information technology and storage systems; our exposure to data corruption, cyber-based attacks, security breaches and privacy violations; competition for and loss of management and key personnel; international risks, including but not limited to, compliance with product registration requirements, compliance with legal requirements, tariffs, exposure to currency exchange fluctuations and foreign currency exchange risk, longer payment cycles, lower selling prices and greater difficulty in collecting accounts receivable, reduced protection of intellectual property rights, social, political and economic instability, increased financial accounting and reporting burdens and complexities, taxes, and diversion of lower priced international products into U.S. markets; changes in tax rates and exposure to additional tax liabilities or assessments; our ability to manage our growth strategy and successfully identify, acquire and integrate potential acquisition targets or technologies and our ability to obtain financing; the level of our deferred payment obligations; that our Revolving Credit Facility is secured by substantially all of our assets; operating and financial restrictions on us under the agreements for our indebtedness and their effect on our ability to operate our business; that we may incur additional indebtedness; dilution resulting from future sales of our equity; volatility in our stock price; provisions in our charter documents and Delaware law that might delay or impede stockholder actions with respect to business combinations or similar transactions; and our intention of not paying dividends. 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, 2019 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.

Quidel Contact:
Quidel Corporation
Randy Steward
Chief Financial Officer
(858) 552-7931

Media and Investors Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
rargueta@quidel.com

Source: Quidel Corporation

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