Award recognizes “an extraordinary year for
Quidel and its CEO”
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today that
Quidel’s President and CEO Douglas Bryant was named Executive of
the Year in the MedTech Dive Awards for 2020. MedTech Dive, a
business publication that provides in-depth reporting on
developments in medical technology, focused its annual awards for
2020 on recognizing companies and people that showed leadership in
a time of crisis.
MedTech Dive’s editors and journalists selected Mr. Bryant as
the medical technology industry’s Executive of the Year in part
because his pre-COVID strategy of developing rapid immunoassay
technologies and building out point-of-care antigen testing for
infectious diseases and conditions such as flu, RSV and strep
positioned the company for success when the pandemic hit. MedTech
Dive credited Mr. Bryant for redirecting Quidel to focus on the
COVID-19 virus and dramatically increasing production of its
diagnostic tests.
“While I am honored by this recognition, I accept it on behalf
of the entire Quidel Team, which has truly stepped up to the
challenge of diagnosing and defeating the COVID-19 virus,” Mr.
Bryant said. “I am extremely proud to be part of an outstanding
organization that is, quite literally, advancing the frontline
response to this pandemic with continuous innovation and
disciplined execution.”
“Our mission at Quidel is to democratize access to accurate,
affordable and, where necessary, frequent testing all across
America,” Mr. Bryant emphasized. “We see it as a moral obligation.
It drives us.”
Quidel was the first company to receive Emergency Use
Authorization (EUA) from the FDA for a rapid antigen test that
delivers results in 15 minutes. Quidel's Sofia® SARS Antigen FIA
set the bar for antigen test performance at 96.7% PPA vs. PCR and
has proven to be critical to both COVID-19 detection and disease
surveillance when combined with Quidel’s proprietary Virena® data
management system, which provides aggregated, de-identified testing
data to the CDC and other public health authorities in near
real-time.
Quidel’s COVID-19 leadership extended from R&D to
manufacturing as the company doubled production of its rapid
antigen test to over two million tests a week in the third quarter.
The company plans to triple that production to six million tests
per week in mid-2021 to address the strong demand for testing,
treatment and tracing that will continue alongside the introduction
of vaccines.
MedTech Dive noted, “The San Diego-based diagnostics company has
delivered record profit and revenue over two successive quarters
since the coronavirus pandemic took hold.”
Quidel Achievements in 2020
Quidel developed and received FDA Emergency Use Authorization
(EUA) for its Lyra® molecular PCR test for COVID-19 on March 17. On
May 8, Quidel became the first company to receive an EUA from the
FDA for a rapid antigen test that delivers results in 15
minutes.
Quidel's Sofia® SARS Antigen FIA set the bar for antigen test
performance at 96.7%. The Sofia® system also comes connected to
Virena®, Quidel’s data management system, which provides
aggregated, de-identified testing data to U.S. public health
authorities in near real-time.
In September, Quidel entered into arrangements with the Pac-12
and Big Ten Conferences that provided daily rapid antigen testing,
which allowed student-athletes to safely return to play and
included research at participating universities that constitutes
the largest asymptomatic coronavirus cohort study ever done.
Quidel doubled Sofia® manufacturing capacity to one million
tests a week in June. By October, Quidel again doubled its U.S.
production capacity for COVID-19 rapid testing to over two million
tests per week.
On October 2, Quidel introduced the first-ever rapid antigen
“ABC Test” in the U.S. that simultaneously detects and
distinguishes between Influenza A, Influenza B and COVID-19 from a
single nasal swab sample in 15 minutes.
Quidel currently has a robust pipeline of molecular and antigen
tests awaiting EUAs from the FDA or expected to be submitted soon.
Applications for these new tests range from hospitals and physician
offices to schools and, ultimately, at-home use.
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
About MedTech Dive
MedTech Dive provides in-depth journalism and insight into the
most impactful news and trends shaping medical technology. The
newsletters and website cover topics such as medical devices,
diagnostics, digital health, regulation/compliance, R&D,
M&A and more. MedTech Dive is part of Industry Dive, a leading
business journalism company.
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 financial 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
or shortages in our supply of raw materials and other components;
the quantity of our product in our distributors’ inventory or
distribution channels, changes in the buying patterns of our
distributors, and 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
new product reviews 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 or clearances 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 an event
of default could trigger acceleration of outstanding indebtedness;
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. 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/20201210006110/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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