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Quidel Corporation CEO Douglas Bryant Named Executive of the Year in MedTech Dive Awards For 2020

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Award recognizes "an extraordinary year for Quidel and its CEO"

Quidel Corporation (NASDAQ: QDEL) ("Quidel"), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel’s President and CEO Douglas Bryant was named Executive of the Year in the MedTech Dive Awards for 2020. MedTech Dive, a business publication that provides in-depth reporting on developments in medical technology, focused its annual awards for 2020 on recognizing companies and people that showed leadership in a time of crisis.

MedTech Dive’s editors and journalists selected Mr. Bryant as the medical technology industry’s Executive of the Year in part because his pre-COVID strategy of developing rapid immunoassay technologies and building out point-of-care antigen testing for infectious diseases and conditions such as flu, RSV and strep positioned the company for success when the pandemic hit. MedTech Dive credited Mr. Bryant for redirecting Quidel to focus on the COVID-19 virus and dramatically increasing production of its diagnostic tests.

"While I am honored by this recognition, I accept it on behalf of the entire Quidel Team, which has truly stepped up to the challenge of diagnosing and defeating the COVID-19 virus," Mr. Bryant said. "I am extremely proud to be part of an outstanding organization that is, quite literally, advancing the frontline response to this pandemic with continuous innovation and disciplined execution."

"Our mission at Quidel is to democratize access to accurate, affordable and, where necessary, frequent testing all across America," Mr. Bryant emphasized. "We see it as a moral obligation. It drives us."

Quidel was the first company to receive Emergency Use Authorization (EUA) from the FDA for a rapid antigen test that delivers results in 15 minutes. Quidel's Sofia® SARS Antigen FIA set the bar for antigen test performance at 96.7% PPA vs. PCR and has proven to be critical to both COVID-19 detection and disease surveillance when combined with Quidel’s proprietary Virena® data management system, which provides aggregated, de-identified testing data to the CDC and other public health authorities in near real-time.

Quidel’s COVID-19 leadership extended from R&D to manufacturing as the company doubled production of its rapid antigen test to over two million tests a week in the third quarter. The company plans to triple that production to six million tests per week in mid-2021 to address the strong demand for testing, treatment and tracing that will continue alongside the introduction of vaccines.

MedTech Dive noted, "The San Diego-based diagnostics company has delivered record profit and revenue over two successive quarters since the coronavirus pandemic took hold."

Quidel Achievements in 2020

Quidel developed and received FDA Emergency Use Authorization (EUA) for its Lyra® molecular PCR test for COVID-19 on March 17. On May 8, Quidel became the first company to receive an EUA from the FDA for a rapid antigen test that delivers results in 15 minutes.

Quidel's Sofia® SARS Antigen FIA set the bar for antigen test performance at 96.7%. The Sofia® system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to U.S. public health authorities in near real-time.

In September, Quidel entered into arrangements with the Pac-12 and Big Ten Conferences that provided daily rapid antigen testing, which allowed student-athletes to safely return to play and included research at participating universities that constitutes the largest asymptomatic coronavirus cohort study ever done.

Quidel doubled Sofia® manufacturing capacity to one million tests a week in June. By October, Quidel again doubled its U.S. production capacity for COVID-19 rapid testing to over two million tests per week.

On October 2, Quidel introduced the first-ever rapid antigen "ABC Test" in the U.S. that simultaneously detects and distinguishes between Influenza A, Influenza B and COVID-19 from a single nasal swab sample in 15 minutes.

Quidel currently has a robust pipeline of molecular and antigen tests awaiting EUAs from the FDA or expected to be submitted soon. Applications for these new tests range from hospitals and physician offices to schools and, ultimately, at-home use.

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

About MedTech Dive

MedTech Dive provides in-depth journalism and insight into the most impactful news and trends shaping medical technology. The newsletters and website cover topics such as medical devices, diagnostics, digital health, regulation/compliance, R&D, M&A and more. MedTech Dive is part of Industry Dive, a leading business journalism company.

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 financial 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 or shortages in our supply of raw materials and other components; the quantity of our product in our distributors’ inventory or distribution channels, changes in the buying patterns of our distributors, and 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 new product reviews 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 or clearances 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 an event of default could trigger acceleration of outstanding indebtedness; 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. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201210006110/en/

Contacts

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