Quidel to Bring QuickVue® At-Home OTC COVID-19 Tests To CVS Pharmacy

QuickVue® At-Home OTC COVID-19 rapid antigen tests available without a prescription at CVS Pharmacy locations nationwide and online at CVS.com

Quidel reports a surge in demand for both its Sofia^® and QuickVue^® COVID-19 rapid antigen tests

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced in the next week it will make Quidel’s non-prescription QuickVue® At-Home OTC COVID-19 Test available to consumers at more than 7,000 CVS Pharmacy locations across the United States and online at cvs.com. The shelf-stable packages each contain two self-administered rapid antigen tests.

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QuickVue® At-Home OTC COVID-19 rapid antigen tests available without a prescription at CVS Pharmacy locations nationwide and online at CVS.com (Photo: Business Wire)

“Making QuickVue® At-Home OTC COVID-19 Tests conveniently available in-store and online at CVS Pharmacy further supports our shared commitment in meeting the testing needs of American families,” said Douglas Bryant, president and CEO of Quidel. “We experienced a recent surge in demand for our portfolio of Sofia SARS and QuickVue COVID-19 rapid antigen tests, and adding capacity through CVS Pharmacy, a leader in providing testing access throughout the pandemic, will help address customers’ demand.”

“Customers have counted on CVS Pharmacy to provide convenient access to testing throughout the pandemic, and we look forward to removing barriers with the addition of QuickVue® At-Home to our array of trusted testing options,” said Brian Eason, Vice President, Consumer Health and Wellness, CVS Pharmacy.

Mr. Bryant continued, “One of our goals all along has been to democratize diagnostic testing and we have held true to that mission. Consistent with our plan communicated earlier in the year, we are continuing to add manufacturing lines and are on-track to reach our target run-rate capacity of approximately 70 million rapid antigen COVID-19 tests per month by the end of the year.”

Mr. Bryant added, “Thanks to our stay-the-course strategy and ever-expanding footprint in the professional and retail channels, Quidel is better positioned to supply product in response to the recent surge in testing demand sparked by the rapid spread of the Delta variant. As a result, over the last month, we have experienced a marked increase in SARS category revenues for the third quarter-to-date 2021 and have surpassed the total COVID-related revenue in the second quarter of 2021. If we have learned anything over the past 18-months, it is that while the testing environment has been, and remains fluid, it is wise to further invest in, and enhance, our agility as the landscape continues to evolve.”

Mr. Bryant concluded, “Additionally, in the quarter and consistent with our strategy to expand access to affordable testing, we have been working with educational institutions to provide free diagnostic product in underserved communities. We look forward to sharing more on these and other initiatives in the future but can report with confidence today that there continues to be both a strong need for COVID testing and an opportunity for us to do our part.”

The QuickVue® At-Home OTC COVID-19 Test allows consumers to easily perform the test themselves without a doctor’s prescription and get results in 10 minutes from nasal swab samples. The QuickVue® At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to individuals running the test and helping to prevent asymptomatic virus spread.

The QuickVue^® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue^® At-Home OTC Covid-19 Test 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.

Visit http://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 of the COVID-19 global pandemic; competition; our ability to accurately forecast demand for our products and products in development, including in new market segments; 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 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; competition for and loss of management and key personnel; 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; funding and compliance risks relating to government contracts, including the ability to meet key deliverables and milestones under our NIH RADx-ATP contract; 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® and BNP businesses 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,; 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.

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