National distribution fulfillment agreement
will make QuickVue® At-Home rapid antigen tests available to
families, schools and workplaces for use without a prescription
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading
provider of rapid diagnostic testing solutions, cellular-based
virology assays and molecular diagnostic systems, announced today
that it has completed a distribution and fulfillment agreement with
McKesson Corporation, a global leader in healthcare supply chain
management solutions and retail pharmacy, to expedite consumer
access to Quidel’s non-prescription QuickVue® At-Home OTC
COVID-19 Test.
The agreement with distribution leader McKesson will enable
Quidel to continue to supply existing customers in the professional
segment and also reach significant new markets as the company
introduces its new over-the-counter COVID-19 antigen product for
retail markets and testing for reopening schools, and for health
departments, employers, entertainment centers, and many other
locations. McKesson will be Quidel’s lead commercial partner in
fulfilling QuickVue® At-Home OTC COVID-19 rapid antigen test orders
to individuals and businesses with the following support:
- Access to multiple retailers, where McKesson will accelerate
our product roll-out strategy.
- Availability to McKesson’s Health Mart franchise, allowing
Quidel access to a network of over 5,000 independent
pharmacies.
- E-commerce support; ability to rapidly introduce products
across multiple e-commerce sites, such as Amazon, eBay, and Simply
Medical, McKesson’s home health e-commerce site.
“We are pleased to partner with McKesson, expecting to leverage
McKesson’s ability to sell and distribute QuickVue through online
channels like Amazon, WalMart.com, and through retail pharmacies,
including their network of independent Health Mart pharmacies,
grocery outlets, as well as health systems and other medical
providers,” said Douglas Bryant, president and CEO of Quidel
Corporation. “This distribution agreement is intended to expedite
broad availability of our QuickVue® At-Home OTC COVID-19 Test for
families, schools and businesses and help Quidel meet our goal of
democratizing access to affordable antigen testing. We are proud
that the combined strength of our two companies working in
partnership can truly advance individual and public health.”
The QuickVue® At-Home OTC COVID-19 Test received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration
(FDA) in March. The QuickVue® At-Home OTC COVID-19 Test allows
consumers to easily perform the test themselves without a doctor’s
prescription and get highly accurate results in 10 minutes or less
from nasal swab samples. The QuickVue® At-Home OTC 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.
Shipping of the QuickVue® At-Home OTC COVID-19 Test is expected
to begin early next week, and it will be available from McKesson
and its customer outlets soon thereafter.
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 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
and duration of the COVID-19 global pandemic; competition from
other providers of diagnostic products; our ability to accurately
forecast demand for our products and products in development,
including in new market segments; 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; 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 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;
our contracts with government entities involve future funding,
compliance and possible sanctions risks; 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® business 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, including the ongoing litigation between us and Beckman
Coulter, Inc.; 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/20210422006101/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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