Sofia® 2 Flu + SARS Antigen FIA
point-of-care test delivers 3 results from 1 sample in 15
minutes
ABC Test comes “just in time” as coronavirus
pandemic and flu season converge
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 Emergency Use Authorization (EUA) from the U.S.
Food and Drug Administration (FDA) to market its Sofia® 2 Flu +
SARS Antigen FIA, a rapid point-of-care test to be used with the
Sofia® 2 Fluorescent Immunoassay Analyzer for the rapid,
simultaneous qualitative detection and differentiation of the
nucleocapsid protein antigens from SARS-CoV-2, influenza A and
influenza B in direct nasopharyngeal (NP) and nasal (NS) swab
specimens from individuals suspected of respiratory viral infection
consistent with COVID-19 by their healthcare provider within the
first five days of the onset of symptoms.
The new Sofia® 2 Flu + SARS Antigen FIA offers excellent
performance for SARS-2 (95.2% PPA versus PCR and 100% NPA versus
PCR), as well as for Influenza A (90% sensitivity versus culture
and 95% specificity versus culture) and Influenza B (89%
sensitivity versus culture and 96% specificity versus culture) in
nasal swabs. Quidel’s new Sofia® test delivers a fast, highly
accurate result for all three viruses from one nasal swab (or
nasopharyngeal swab) sample in just 15 minutes, providing critical
answers to patients and healthcare workers alike.
“As the COVID-19 pandemic converges with seasonal influenza,
public health experts face the potential for a ‘perfect storm’ of
patients exhibiting similar but distinct medical conditions that
require different treatment methods,” said Douglas Bryant,
president and CEO of Quidel Corporation. “It is essential for
doctors to know what they’re dealing with quickly.”
“This new three-way test to identify and separate influenza
strains from coronavirus has arrived just in time for flu season,”
said Dr. John Fallon, Medical Director, Vidant Healthcare System.
“Quidel has achieved a diagnostic breakthrough that will save time,
resources and lives. This is welcome news for healthcare providers
already under immense strain from COVID-19 and facing the added
challenge of virulent influenza.”
Quidel was the first company to develop an EUA cleared rapid
point-of-care antigen test for COVID-19 and remains at the
forefront of the battle against COVID-19. The company also
developed the first flu test, the QuickVue® Influenza A/B Test,
which received FDA approval in September of 1999. With the
introduction of its ABC Test, Quidel has registered another
first-of-its-kind innovation that packs both its flu and SARS
diagnostic technologies onto one highly efficient test cartridge
that can be manufactured on the same production lines now used for
Sofia® SARS tests. By enabling three tests to be performed
simultaneously on a single cartridge using a single swab sample,
the company can scale seasonal production of flu tests without
impacting its scheduled ramp of COVID-19 antigen test capacity.
While symptoms of flu and COVID are similar, JAMA reports that
treatments are different. Even in non-pandemic years, influenza is
a serious public health concern. According to a recent report in
ScienceAdvances, the flu and other causes of pneumonia are the
eighth leading cause of death in the United States.
Mr. Bryant added: “We believe that our new ABC Test (Sofia® 2
Flu + SARS Antigen FIA) will help reduce misdiagnosis, inform
proper treatment and improve disease surveillance, significantly
enhancing medical effectiveness in fighting COVID-19 and the flu,”
Bryant concluded. “We are proud to put this powerful diagnostic
tool in the hands of physicians and public health agencies at this
critical time.”
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 in near
real-time.
The Sofia® 2 instrument also offers two distinct workflows:
depending upon the user’s choice, the Sofia® 2 SARS Antigen FIA
cartridge is placed inside Sofia® 2 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 Sofia® 2 to be scanned (READ NOW Mode), allowing the
user to markedly increase testing throughput per hour.
The Sofia® 2 Flu + SARS Antigen FIA is currently available for
sale in the United States under EUA, and Quidel is now shipping the
product to its customers. Quidel also offers the Sofia® SARS
Antigen FIA under EUA as well as several other Sofia® assays, 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.
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.
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 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/20201002005509/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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