Quidel Statement on the Omicron Variant
November 30 2021 - 4:10PM
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 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/
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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