Carlsbad, CA facility aims to reach a run rate
of 600 million QuickVue® tests per year by end of 2021
Future plans call for production of numerous
popular QuickVue® diagnostic tests to serve the emerging at-home
testing market
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading
provider of rapid diagnostic testing solutions, cellular-based
virology assays and molecular diagnostic systems, today announced
the opening of a new manufacturing facility in Carlsbad, CA that
will be dedicated to the production of Quidel’s popular QuickVue®
line of products. The 128,000 square-foot facility will be the
company’s highest-volume production plant in the world and begins
operations in the second half of 2021 with a mission to produce 600
million QuickVue® SARS rapid antigen tests per year for the
detection and diagnosis of COVID-19 infections.
Quidel plans to install multiple manufacturing lines at the
Carlsbad facility and hire approximately 400 new employees with a
mission to scale Quidel’s operations from 50 million QuickVue®
tests per year to 50 million tests per month at full capacity,
including non-COVID-19 diagnostic assays currently in-market or
under development. The company is actively hiring to fill open
positions including engineers, chemists, technicians,
manufacturing, purchasing, sourcing and support services.
“From the first days of the pandemic, Quidel has stepped up to
meet the COVID-19 challenge head-on with innovative diagnostic
technologies to detect coronavirus infections and expanded
manufacturing to democratize access to affordable and high-quality
testing,” said Douglas Bryant, president and CEO of Quidel
Corporation. “The opening of our massive new QuickVue®
manufacturing plant is our boldest move yet and is expected to
provide Quidel with the scale necessary to serve the needs of
communities and institutions for frequent testing now and for years
to come.”
Quidel received Emergency Use Authorization (EUA) from the U.S.
Food and Drug Administration (FDA) for its QuickVue® SARS Antigen
Test for COVID-19 in December. The company’s QuickVue® lateral-flow
technology is visually read by the user and provides results in 10
minutes from nasal swab samples. Initial applications for QuickVue®
COVID-19 tests range from hospitals and physician offices to
schools and pharmacies. Quidel is seeking EUA for a new QuickVue®
At-Home COVID-19 Test for over-the-counter sale directly to
consumers.
Quidel’s new QuickVue® SARS Antigen test offers excellent
performance for the detection of SARS-CoV-2, with positive results
agreeing with PCR 96.6% of the time and negative results agreeing
99.3% of the time, thereby providing quick, reliable results to
patients, their families and healthcare workers alike.
In the professional segment, Quidel has manufactured the
QuickVue® line for over 30 years. Quidel was the first company to
introduce a visually read flu test, the QuickVue® Influenza A/B
Test, which received FDA approval in September of 1999. QuickVue®
was also the first flu test cleared by the FDA for use in
CLIA-Waived point-of-care facilities like doctors’ offices, urgent
care clinics and pharmacies.
Today, Quidel’s QuickVue® diagnostic products that test for
Influenza, RSV, Strep A, fecal occult blood, pregnancy, chlamydia,
infectious mononucleosis, adenoviral conjunctivitis and H. pylori.
Over the years, more than 150 million QuickVue® diagnostic testing
units have been sold.
To learn more about our available positions, please visit:
https://careers.quidel.com/
Background Information:
Throughout this pandemic, Quidel has been at the forefront of
diagnostic innovation. From the company’s Lyra® PCR tests, to its
Sofia® rapid antigen tests for COVID-19, to its Sofia® “ABC”
combination test for the Influenza A+B and coronavirus, to its
QuickVue SARS-CoV-2 test authorized for emergency use by the FDA in
December, Quidel has significantly advanced the science and the
scale of its operations.
Quidel was the first company to receive EUA from the FDA for a
rapid point-of-care antigen test for COVID-19 and remains at the
forefront of the battle against the coronavirus pandemic.
Sofia® 2 is Quidel’s best-selling cartridge-based,
instrument-read rapid diagnostic system for infectious disease
testing, which utilizes fluorescent chemistry design, an intuitive
graphical user interface, and optics system to provide a highly
accurate, objective and automated result in 15 minutes. The Sofia®
2 system also comes connected to Virena®, Quidel’s data management
system, which provides aggregated, de-identified testing data to
public health authorities in near real-time.
In 2020, Quidel quickly increased its production of Sofia® rapid
antigen tests from approximately 500,000 units per week to a rate
of over 2 million tests per week at the end of December. Quidel is
building additional production lines with a goal to reach a
run-rate of over 240 million Sofia® tests per year by the third
quarter of 2021. In 2020, the company also increased the installed
base of Sofia® diagnostic instruments to more than 65,000
point-of-care locations.
Quidel’s QuickVue® and Sofia® SARS Antigen test kits are made in
the greater San Diego metropolitan area of California.
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 novel virus (COVID-19) global pandemic; funding
and compliance risks relating to government contracts, including
our ability to meet key deliverables and milestones under our NIH
RADx-ATP contract; our ability to accurately forecast demand for
our products and products in development, including in new market
segments; adverse changes in competitive conditions; the
reimbursement system currently in place and future changes to that
system; changes in economic conditions in our domestic and
international markets; lower than anticipated market penetration of
our products; our reliance on sales of our influenza and COVID-19
diagnostic tests; fluctuations in our operating results resulting
from the timing of the onset, length and severity of cold and flu
seasons, seasonality, government and media attention focused on
influenza and other respiratory or novel viruses and the related
potential impact on humans from such viruses; our ability to meet
demand for our products; interruptions, delays or shortages in the
supply of raw materials, equipment and other components; the
quantity of our product in our distributors’ inventory or
distribution channels; changes in the buying patterns of our
distributors; changes in the healthcare market and consolidation of
our customer base; our development, acquisition and protection of
proprietary technology rights; our ability to develop new
technologies, products and markets and to commercialize new
products; our reliance on a limited number of key distributors; 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.; intellectual property risks, including but not
limited to, infringement litigation; our ability to finance our
capital or operating needs; the financial soundness of our
customers and suppliers; acceptance of our products among
physicians and other healthcare providers; competition from other
providers of diagnostic products; 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; changes in government policies; costs of
and adverse operational impact from failure to comply with
government regulations in addition to FDA regulations; compliance
with government regulations relating to the handling, storage and
disposal of hazardous substances; third-party reimbursement
policies and potential cost constraints; our failure to comply with
laws and regulations relating to billing and payment for healthcare
services; product defects; business risks not covered by insurance;
costs and disruptions from failures in our information technology
and storage systems; our exposure to data corruption, cyber-based
attacks, security breaches and privacy violations; competition for
and loss of management and key personnel; international risks,
including but not limited to, compliance with product registration
requirements, compliance with legal requirements, tariffs, exposure
to currency exchange fluctuations and foreign currency exchange
risk, longer payment cycles, lower selling prices and greater
difficulty in collecting accounts receivable, reduced protection of
intellectual property rights, social, political and economic
instability, increased financial accounting and reporting burdens
and complexities, taxes, and diversion of lower priced
international products into U.S. markets; changes in tax rates and
exposure to additional tax liabilities or assessments; our ability
to manage our growth strategy and successfully identify, acquire
and integrate potential acquisition targets or technologies and our
ability to obtain financing; the level of our deferred payment
obligations; that our Revolving Credit Facility is secured by
substantially all of our assets; operating and financial
restrictions on us under the agreements for our indebtedness and
their effect on our ability to operate our business; that we may
incur additional indebtedness; dilution resulting from future sales
of our equity; volatility in our stock price; provisions in our
charter documents and Delaware law that might delay or impede
stockholder actions with respect to business combinations or
similar transactions; and our intention of not paying dividends.
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, 2019 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210203005849/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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