Quidel’s Antigen Tests Detect the Omicron Variant
December 28 2021 - 6:00PM
Business Wire
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
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, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211228005190/en/
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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