Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today that
Quidel has entered into a preliminary letter contract with the
National Institutes of Health (NIH) through its newly launched
Rapid Acceleration of Diagnostics - Advanced Technology Platforms
(RADx-ATP) initiative to support the expansion of its manufacturing
capacity in San Diego for its diagnostic assays that test for
SARS-CoV-2 Antigen using its Sofia® Fluorescence Immunoassay (FIA)
platform. Quidel and the NIH endeavor to enter into a definitive
agreement to support the initiative by mid-September.
The NIH RADx-ATP investment, subject to entering into the
definitive agreement with key deliverables and identified
milestones, would directly support the upgrade and addition of new
manufacturing lines, thereby expanding capacity for test cassettes
from approximately 84 million cassettes per year to in excess of
220 million cassettes per year. This investment would also support
the outfitting of a larger distribution center that would be needed
for the greatly expanded yield of rapid diagnostic assays,
including not only those for COVID-19 diagnosis, but also for
influenza, RSV, and other infectious diseases. The contract period
would be for one year beginning on July 30, 2020.
Quidel is known for its production of fast, accurate, affordable
rapid diagnostic products—and, importantly for their ease-of-use
and CLIA waiver—making them especially well-suited for
Point-of-Care applications. Sofia® is the name of Quidel’s
best-selling instrumented system. Sofia and Sofia 2, its
second-generation Analyzer, both employ a fluorescence-based,
lateral flow immunochemistry design and state-of-the-art optics to
provide an accurate, objective and automated result in 15 minutes
or less. When needed, its Read Now or Batch Test Mode enables
getting results for up to 50 patient specimens within one hour. The
Sofia Analyzers also come connected to Virena®, Quidel’s data
management system, which wirelessly provides aggregated,
de-identified testing data in near real time to users of the system
for laboratory management and to public health agencies, state and
federal, for bio-surveillance.
Quidel currently sells several different Sofia assays in the
United States, including the Sofia® SARS Antigen FIA under FDA EUA
and other FDA-cleared and CLIA-waived assays, including tests for
Influenza A and B, Respiratory Syncytial Virus (RSV), Group A
Strep, and a 15-minute finger-stick whole blood test for Lyme
Disease. In addition, Quidel also markets Sofia® tests for Lyme
Disease, Legionella, and S. pneumoniae in Europe.
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, COVID-19, 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.
About the project:
This project is supported by the NIH Rapid Acceleration of
Diagnostics - Advanced Technology Platforms (RADx-ATP) program and
has been funded in whole or in part with Federal funds from the
Office of the Director, National Institutes of Health, Department
of Health and Human Services, under Contract No.
75N92020C00013.
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 other respiratory or novel
virus 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 in our supply of raw materials; 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 Naturietic Peptide assay
business (the “Triage and BNP Businesses”); 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/20200731005114/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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