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 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. Recent testing using live South African samples confirmed that our QuickVue® At-Home OTC COVID-19 Test and our Sofia® SARS Antigen FIA are detecting the SARS-CoV-2 Omicron variant.
On December 22, 2021, the Food and Drug Administration (FDA) indicated that data generated in preliminary RADx laboratory studies, with heat-inactivated Omicron samples, suggested that the QuickVue antigen tests are able to detect the Omicron variant with similar performance as with other variants. Additional testing has now been completed by the same laboratory using live virus. These data also suggest that the QuickVue antigen tests are able to detect the live Omicron variant with similar performance as with other variants.
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 weekly production of COVID-19 antigen tests in an effort to provide our communities with access to affordable COVID-19 testing. Quidel has risen to the challenge and we are proud to be at the forefront of the diagnostic industry’s response to the pandemic.”
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
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, including our products’ efficacy as the coronavirus evolves; 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; our pending acquisition of Ortho Clinical Diagnostics Holdings plc, including failure to complete the proposed transaction on the proposed terms or on the anticipated timeline, or at all, and other risks described in our periodic and other 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.
Chief Financial Officer