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

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

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