Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, issued the following
statement supporting the Administration’s plans to provide COVID-19
rapid tests to school children.
“Quidel Corporation welcomes President Trump’s announcement that
the Administration will direct millions of Abbott’s visually read
antigen tests for use in safeguarding K-12 school children as they
return to America’s classrooms. In this pandemic, the medical
diagnostics industry is competing against COVID-19, not among
companies. The need for testing seems virtually unlimited at this
point in time. So, while Quidel continues our aggressive efforts to
ramp production of our own rapid antigen tests, we appreciate the
contributions of others and the leadership of the Trump
Administration in clarifying how the special needs of school
children will be addressed. Today’s announcement gives us greater
certainty in confirming our commitments to existing customers and
greater flexibility to serve additional markets as our production
capacity expands.
“Quidel recently doubled our production of Sofia® rapid antigen
tests to the current rate of approximately two million tests per
week. We are constructing additional production lines that will
more than double our current capacity once again. Our goal is to
reach a run-rate of over 220 million tests per year by July of
2021.
“We are proud of the commitment demonstrated by our Quidel team
since the first day we started developing our PCR and antigen tests
for COVID-19. Our people have been so dedicated and their ability
to speed and scale production has been extraordinary. It is
noteworthy that all of Quidel’s Sofia® SARS Antigen test kits are
made in America -- at our manufacturing facility near our corporate
headquarters in San Diego.”
Background Information:
Quidel was the first company to receive EUA from the FDA for a
rapid antigen test that delivers results in 15 minutes.
Sofia® 2 is Quidel’s best-selling cartridge-based 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.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being
of people around the globe through the development of diagnostic
solutions that can lead to improved patient outcomes and provide
economic benefits to the healthcare system. Marketed under the
Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and
InflammaDry® leading brand names, as well as under the new Solana®,
AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products
aid in the detection and diagnosis of many critical diseases and
conditions, including, among others, influenza, respiratory
syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease
and fecal occult blood. Quidel's Triage® system of tests comprises
a comprehensive test menu that provides rapid, cost-effective
treatment decisions at the point-of-care (POC), offering a diverse
immunoassay menu in a variety of tests to provide diagnostic
answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I
and qualitative TOX Drug Screen. Quidel’s research and development
engine is also developing a continuum of diagnostic solutions from
advanced immunoassay to molecular diagnostic tests to further
improve the quality of healthcare in physicians’ offices and
hospital and reference laboratories. For more information about
Quidel’s comprehensive product portfolio and to explore exciting
employment opportunities, visit quidel.com.
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 of the novel virus (COVID-19) global pandemic; an
inability to agree on a definitive agreement or meet key
deliverables and milestones under the NIH’s RADx-ATP contract;
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, 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 development of new technologies, products and markets;
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 need for additional funds 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 with 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; our ability to meet demand for our products;
interruptions or shortages in our supply of raw materials and other
components; 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; risks relating to our acquisition and integration of
the Triage MeterPro Cardiovascular and toxicology business and
B-type Natriuretic Peptide assay business; that we may have to
write off goodwill relating to our acquisitions; our ability to
manage our growth strategy and identify and integrate acquired
companies or technologies and our ability to obtain financing; the
level of our indebtedness and deferred payment obligations; our
ability to generate sufficient cash to meet our debt service and
deferred and contingent payment obligations; that our Revolving
Credit Facility is secured by substantially all of our assets; the
agreements for our indebtedness place operating and financial
restrictions on us and our ability to operate our business; that an
event of default could trigger acceleration of our outstanding
indebtedness; that we may incur additional indebtedness; increases
in interest rate relating to our variable rate debt; dilution
resulting from future sales of our equity; volatility in our stock
price; provisions in our charter documents, Delaware law and the
indenture governing our Convertible Senior Notes that might delay
or impede stockholder actions with respect to business combinations
or similar transactions; our intention of not paying dividends; and
our ability to identify and successfully acquire and integrate
potential acquisition targets. 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 (the “SEC”) 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 the results of 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/20200928005751/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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