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Quidel Supports New NIH, CDC Public Health Initiative for At-home COVID-19 Testing

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Company is providing two million QuickVue® At-Home OTC COVID-19 Tests for "Say Yes! COVID Test" community health initiative in Pitt County, NC, and Chattanooga/Hamilton County, TN

Study seeks to determine if frequent at-home COVID-19 testing helps residents reduce community transmission of SARS-CoV-2

Quidel Corporation (NASDAQ: QDEL) ("Quidel"), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it is partnering with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) on an innovative community health initiative called "Say Yes! COVID Test" in Pitt County, North Carolina, and coming soon to Chattanooga/Hamilton County, Tennessee. Quidel is providing two million QuickVue® At-Home OTC COVID-19 Tests to be distributed to approximately 160,000 residents free of charge across the two communities. The study is designed to determine if access to at-home rapid antigen tests three times a week for one month can significantly reduce virus spread in vulnerable communities.

Quidel’s QuickVue® At-Home OTC COVID-19 Test is a visually read assay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 and requires no instrument to perform the test. The easy-to-use QuickVue® At-Home OTC COVID-19 Test will allow the program’s participants to easily perform the test themselves and get results in 10 minutes. The QuickVue® At-Home OTC 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 peace of mind to people running the test and facilitating reporting of results to the public health initiative’s sponsors via a customized app developed for the "Say Yes! COVID Test" initiative.

Quidel’s QuickVue® At-Home OTC COVID-19 Test is being supplied through the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative. Selection of the two communities was based on local infection rates, public availability of accurate COVID-19 tracking data, existing community relationships through the NIH Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) and local infrastructure to support the project.

"This testing initiative is the first of this scale to attempt to make free, rapid, self-administered tests available community-wide in order to determine their effectiveness in our nation’s comprehensive response to the COVID-19 pandemic," said NIH Director Francis S. Collins, M.D., Ph.D. "We hope to gain foundational data that can guide how communities can use self-administered tests to mitigate viral transmission during this and future pandemics."

Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.1 Further, a self-administered rapid test produces results at home in minutes, while laboratory processing takes longer and increases cost.

"Scientific evidence is emerging that serial COVID-19 testing with rapid antigen tests can catch infected people early and empower them to take steps to protect themselves, their families and their entire community," said Douglas Bryant, president and CEO of Quidel Corporation. "As citizens and as a company, Quidel has worked to support the greatest need and the greatest good as we democratize access to frequent and affordable coronavirus testing. This partnership with CDC and NIH to show the power of serial testing to contain virus spread in underserved communities is emblematic of that commitment."

In addition to CDC, NIH and Quidel, the "Say Yes! COVID Test" initiative is a collaboration with the state and local public health departments in North Carolina and Tennessee, NIH, research institutions including Duke University, the University of North Carolina, North Carolina Central University, test manufacturer Quidel, healthcare technology company CareEvolution, community engagement partners from RADx-UP, and Community-Campus Partnerships for Health.

For more information on the QuickVue® At-Home OTC COVID-19 Test visit www.quickvueathome.com.

This project is supported by the NIH Rapid Acceleration of Diagnostics - Advanced Technology Platforms (RADx-ATP) program and has been funded in whole or in part with Federal funds from the Office of the Director, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00013.

  1. https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210331006070/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