QuickVue® At-Home OTC COVID-19 rapid antigen
tests available without a prescription at CVS Pharmacy locations
nationwide and online at CVS.com
Quidel reports a surge in demand for both its
Sofia® and QuickVue® COVID-19 rapid antigen tests
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced in the next week
it will make Quidel’s non-prescription QuickVue® At-Home OTC
COVID-19 Test available to consumers at more than 7,000 CVS
Pharmacy locations across the United States and online at cvs.com.
The shelf-stable packages each contain two self-administered rapid
antigen tests.
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the full release here:
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QuickVue® At-Home OTC COVID-19 rapid
antigen tests available without a prescription at CVS Pharmacy
locations nationwide and online at CVS.com (Photo: Business
Wire)
“Making QuickVue® At-Home OTC COVID-19 Tests conveniently
available in-store and online at CVS Pharmacy further supports our
shared commitment in meeting the testing needs of American
families,” said Douglas Bryant, president and CEO of Quidel.
“We experienced a recent surge in demand for our portfolio of Sofia
SARS and QuickVue COVID-19 rapid antigen tests, and adding capacity
through CVS Pharmacy, a leader in providing testing access
throughout the pandemic, will help address customers’ demand.”
“Customers have counted on CVS Pharmacy to provide convenient
access to testing throughout the pandemic, and we look forward to
removing barriers with the addition of QuickVue® At-Home to our
array of trusted testing options,” said Brian Eason, Vice
President, Consumer Health and Wellness, CVS Pharmacy.
Mr. Bryant continued, “One of our goals all along has been to
democratize diagnostic testing and we have held true to that
mission. Consistent with our plan communicated earlier in the year,
we are continuing to add manufacturing lines and are on-track to
reach our target run-rate capacity of approximately 70 million
rapid antigen COVID-19 tests per month by the end of the year.”
Mr. Bryant added, “Thanks to our stay-the-course strategy and
ever-expanding footprint in the professional and retail channels,
Quidel is better positioned to supply product in response to the
recent surge in testing demand sparked by the rapid spread of the
Delta variant. As a result, over the last month, we have
experienced a marked increase in SARS category revenues for the
third quarter-to-date 2021 and have surpassed the total
COVID-related revenue in the second quarter of 2021. If we have
learned anything over the past 18-months, it is that while the
testing environment has been, and remains fluid, it is wise to
further invest in, and enhance, our agility as the landscape
continues to evolve.”
Mr. Bryant concluded, “Additionally, in the quarter and
consistent with our strategy to expand access to affordable
testing, we have been working with educational institutions to
provide free diagnostic product in underserved communities. We look
forward to sharing more on these and other initiatives in the
future but can report with confidence today that there continues to
be both a strong need for COVID testing and an opportunity for us
to do our part.”
The QuickVue® At-Home OTC COVID-19 Test allows consumers to
easily perform the test themselves without a doctor’s prescription
and get results in 10 minutes from nasal swab samples. The
QuickVue® At-Home 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 confidence to
individuals running the test and helping to prevent asymptomatic
virus spread.
The QuickVue® At-Home OTC COVID-19 Test is only for use under
the Food and Drug Administration’s Emergency Use Authorization. The
QuickVue® At-Home OTC Covid-19 Test has not been FDA cleared or
approved. The test has been authorized only for the detection of
proteins from SARS-CoV-2, not for any other viruses or pathogens,
and is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use
of in vitro diagnostic tests for detection and/or diagnosis of
COVID-19 under Section 564(b)(1) of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
Visit http://www.quickvueathome.com for more information.
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 within
the meaning of the federal securities laws that involve material
risks, assumptions and uncertainties. Many possible events or
factors could affect our future results and performance, such that
our actual results and performance may differ materially from those
that may be described or implied in the forward-looking statements.
As such, no forward-looking statement can be guaranteed.
Differences in actual results and performance may arise as a result
of a number of factors including, without limitation: the impact of
the COVID-19 global pandemic; competition; our ability to
accurately forecast demand for our products and products in
development, including in new market segments; our ability to meet
demand for our products; interruptions, delays or shortages in the
supply of raw materials, components and other products and
services; failures in our information technology and storage
systems; our ability to develop new technologies, products and
markets and to commercialize new products; our reliance on sales of
our COVID-19 and influenza diagnostic tests; our reliance on a
limited number of key distributors; quantity of our product in our
distributors’ inventory or distribution channels; changes in the
buying patterns of our distributors; the financial soundness of our
customers and suppliers; lower than anticipated market penetration
of our products; third-party reimbursement policies and potential
cost constraints; competition for and loss of management and key
personnel; our exposure to data corruption, cyber-based attacks,
security breaches and privacy violations; international risks,
including but not limited to, economic, political and regulatory
risks; continuing worldwide political and social uncertainty; our
development, acquisition and protection of proprietary technology
rights; intellectual property risks, including but not limited to,
infringement litigation; the loss of Emergency Use Authorizations
for our COVID-19 products and failures or delays in receipt of
reviews or regulatory approvals, clearances or authorizations for
new products or related to currently-marketed products by the U.S.
Food and Drug Administration (the “FDA”) or other regulatory
authorities or loss of any previously received regulatory
approvals, clearances or authorizations or other adverse actions by
regulatory authorities; funding and compliance risks relating to
government contracts, including the ability to meet key
deliverables and milestones under our NIH RADx-ATP contract;
product defects; changes in government policies and regulations and
compliance risks related thereto; our ability to manage our growth
strategy and successfully identify, acquire and integrate potential
acquisition targets or technologies and our ability to obtain
financing; our acquisition of Alere’s Triage® and BNP businesses
presents certain risks to our business and operations; the level of
our deferred payment obligations; our exposure to claims and
litigation that could result in significant expenses and could
ultimately result in an unfavorable outcome for us,; we may need to
raise additional funds to finance our future capital or operating
needs; our debt, deferred and contingent payment obligations;
competition for and loss of management and key personnel; business
risks not covered by insurance; changes in tax rates and exposure
to additional tax liabilities or assessments; and provisions in our
charter documents and Delaware law that might delay or impede
stockholder actions with respect to business combinations or
similar transactions. Forward-looking statements typically are
identified by the use of terms such as “may,” “will,” “should,”
“might,” “expect,” “anticipate,” “estimate,” “plan,” “intend,”
“goal,” “project,” “strategy,” “future,” and similar words,
although some forward-looking statements are expressed differently.
The risks described in reports and registration statements that we
file with the Securities and Exchange Commission from time to time,
should be carefully considered, including those discussed in Item
1A, “Risk Factors” and elsewhere in our Annual Report on Form 10 K
for the year ended December 31, 2020 and in our subsequent
Quarterly Reports on Form 10 Q. You are cautioned not to place
undue reliance on these forward-looking statements, which reflect
management’s analysis only as of the date of this press release.
Except as required by law, we undertake no obligation to publicly
release any revision or update of these forward-looking statements,
whether as a result of new information, future events or
otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210901005933/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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