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Quidel Statement on the Omicron Variant

By: Quidel Corporation via Business Wire

November 30, 2021 at 16:10 PM EST

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, issued the following statement from Douglas Bryant, Quidel’s President and CEO, regarding Quidel’s ongoing efforts to evaluate COVID-19 mutations and confirm that its American-made PCR and antigen tests continue to detect COVID-19 variants such as Omicron.

Mr. Bryant said:

“At Quidel, we continuously monitor the evolution and activity of COVID-19 variants in circulation, and the Omicron variant is no exception. Regarding our PCR assays, in silico analysis of the GISAID database showed that 100% of all 206 published sequences of the Omicron variant are covered by our primer and probe combinations. Regarding our antigen assays, GISAID analysis shows a high likelihood that the Omicron variant is detectable by our immunoassays. Of course, we are following up these analyses by testing live samples, and Quidel, like our industry peers, will know more in time.

“While our studies are ongoing, the early data give us confidence that our American-made PCR and rapid antigen tests can detect COVID-19 caused by the Omicron variant. Quidel has been, and will continue to be, vigilant in evaluating our assays with both genetic sequencing and real-world virus sample studies to assure customers of our products’ efficacy as the coronavirus evolves.

“In the meantime, we continue to increase our manufacturing capacity to a run-rate of 70 million tests per month by the end of the year in an effort to provide our communities with access to affordable COVID-19 testing. Quidel has been at the forefront of the diagnostic industry’s response to the pandemic and will continue to lead the response going forward.”

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 that involve material risks, assumptions, and uncertainties. Forward-looking statements typically contain terms such as “may,” “will,” “should,” “might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” and similar words. Various factors could cause our actual results and performance to differ materially from the forward-looking statements. Factors that could contribute to such differences include: impacts of the COVID-19 pandemic; competition; our development of new technologies, products, and markets; our reliance on sales of our COVID-19 and influenza diagnostic tests; our reliance on a limited number of key distributors; acceptance of our products among physicians, healthcare providers, or other customers; the impact of third-party reimbursement policies; our ability to meet demand for our products; interruptions in our supply of raw materials and other components; costs and disruptions from failures in our information technology and storage systems; international risks, including compliance with product registration requirements and legal requirements, tariffs, currency exchange fluctuations, reduced protection of intellectual property rights, and taxes; worldwide economic, political, and social uncertainty; our development, acquisition, and protection of proprietary technology rights; intellectual property risks and third-party claims of infringement; loss of our Emergency Use Authorization from the U.S. Food and Drug Administration for our COVID-19 products; failures or delays in receiving regulatory approvals, clearances, or authorizations, the loss of previously received approvals, or other adverse actions by regulatory authorities; performance, timing, funding and compliance risks relating to government contracts; product defects; compliance with government regulations relating to the handling, storage, and disposal of hazardous substances; our ability to identify and successfully acquire and integrate potential acquisition targets; our need for additional funds to finance our capital or operating needs; and other risks described in our periodic reports and registration statements filed with the Securities and Exchange Commission. Except as required by law, we undertake no obligation to update these forward-looking statements for revisions or changes after the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211130006040/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

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