Sofia® SARS Antigen FIA Point-of-Care test
offers positive results in 15 minutes
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 received an amended Emergency Use Authorization (EUA)
from the U.S. Food and Drug Administration (FDA), allowing Quidel
to run its Sofia® SARS Antigen FIA, a rapid point-of-care test for
COVID-19, on the Sofia® Fluorescent Immunoassay Analyzer (“Sofia
1”), Quidel’s first-generation automated immunoassay instrument.
Quidel previously received EUA to run the Sofia SARS Antigen FIA on
the second-generation Sofia 2 instrumented system.
Sofia 1 is Quidel’s first-generation instrumented system, which
provides an accurate, objective and automated result in 15 minutes.
Like the Sofia 2, the original Sofia 1 instrument offers 2 distinct
workflows: depending upon the user’s choice, the Sofia SARS Antigen
FIA cartridge is placed inside the instrument for automatically
timed development (WALK AWAY Mode); or test cartridges can be
placed on the counter or bench top for a manually timed development
and then placed into the instrument to be scanned (READ NOW Mode),
allowing the user to markedly increase testing throughput per hour.
There are approximately 20,000 Sofia 1 instruments installed in
hospitals and physician offices worldwide.
“This EUA amendment permits our novel Sofia® SARS Antigen test
to be used on both models of our Sofia instruments, leveraging our
worldwide installed base of over 43,000 combined placements,
allowing many of our larger healthcare facilities to be able to
quickly diagnose first responders, healthcare workers, and other
high priority personnel,” said Douglas Bryant, president and chief
executive officer of Quidel Corporation. “The demand for the Sofia
SARS Antigen test kits and Sofia instruments has been phenomenal.
In under 10 days, we had over 1,000 sites on contract and continue
to expect that we will ship every cartridge that we can manufacture
for the foreseeable future.”
The Sofia SARS Antigen FIA is to be used as an aid in the rapid
detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from
patients meeting the Centers for Disease Control and Prevention’s
(CDC) criteria for suspected COVID-19 infection. The assay is
currently available for sale in the United States under EUA, and
Quidel is now shipping the product to its customers. Quidel offers
several other Sofia assays for sale, which are FDA cleared and CLIA
waived, 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.
Healthcare professionals can purchase the Sofia SARS Antigen FIA
through distribution representatives for Cardinal Health, Fisher
Healthcare, Henry Schein, McKesson, or Medline.
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;
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, 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, 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 and
protection of proprietary technology rights; our development of new
technologies, products and markets; our reliance on sales of our
influenza diagnostic tests; our reliance on a limited number of key
distributors; our exposure to claims and litigation, including the
ongoing litigation between the Company 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; adverse actions or delays in 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; changes in government policies; costs of or our
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; 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; failures in our
information technology or storage systems; our exposure to
cyber-based attacks and security breaches; competition for and loss
of management and key personnel; international risks, including but
not limited to, compliance with multiple product registration
requirements, compliance with U.S. and foreign import/export laws,
tariffs, exposure to currency exchange fluctuations and foreign
currency exchange risk sharing arrangements, longer payment cycles,
lower selling prices and greater difficulty in collecting accounts
receivable, reduced protection of intellectual property rights,
political and economic instability, increased financial accounting
and reporting burdens, 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 identify and integrate acquired
companies or technologies; risks relating to the acquisition and
integration of the Triage and BNP Businesses; that we may have to
write off goodwill relating to our acquisitions; the level of our
indebtedness and deferred payment obligations; our ability to
generate sufficient cash flow to meet our debt service and deferred
payment obligations; that we may incur additional indebtedness;
that the Senior Credit Facility is secured by substantially all of
our assets; the agreements for our indebtedness place operating and
financial restrictions on the Company; that an event of default
could trigger acceleration of our outstanding 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; 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 (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/20200609005843/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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