Quidel Receives Amended Emergency Use Authorization for New Sofia® Q Rapid Antigen Test Device
June 11 2021 - 4:10PM
Business Wire
Sofia® Q device features a miniaturized,
AI-powered design
Quidel plans initial release to professional
and point-of-care segments with a goal of expansion to serve
telemedicine and home markets
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 the
company to market Sofia® Q, its latest addition to the
Sofia® and Sofia® 2 line of Fluorescent Immunoassay Analyzers
(FIA). Sofia Q features a sleek, miniaturized design that reads the
same Sofia® SARS Antigen FIA tests as Sofia and Sofia 2 - with
equal accuracy. Sales of Sofia Q device will initially be limited
to use with the Sofia® SARS Antigen FIA in the CLIA and CLIA-waived
professional segments.
Sofia Q is the latest product in Quidel’s best-selling Sofia
instrumentation portfolio. Sofia Q utilizes Sofia® fluorescent
technology to provide an accurate, objective, and automated result
in 15 minutes. Quidel’s innovative design allows the Sofia Q device
to be paired with the downloadable Sofia Q mobile application,
which guides the user through the workflow and interprets the test
result using a proprietary AI model.
“Sofia Q is our latest powerful diagnostic instrument designed
to democratize access to the many benefits of our Sofia SARS rapid
antigen tests and, ultimately, our full portfolio of Sofia tests
for influenza, RSV, Strep and other conditions,” said Douglas
Bryant, president and chief executive officer of Quidel
Corporation. “We designed Sofia Q to be very affordably priced and
conducive to widespread adoption across the ever-expanding global
point-of-care and telemedicine marketplace. In the future, we
believe Sofia Q will be ideal to serve consumers at home, as well
as in schools and workplaces.”
In addition to the Sofia Q, Quidel offers other rapid diagnostic
instrumented systems, including Sofia 2, and Sofia. Quidel’s Sofia
assays for rapid antigen COVID-19 diagnosis include Sofia® 2 SARS
Antigen FIA and Sofia® 2 Flu + SARS Antigen FIA, currently under
EUA by the FDA. Quidel offers other FDA-cleared and CLIA-waived
tests including 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 (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.
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 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 COVID-19 global pandemic; competition from
other providers of diagnostic products; our ability to accurately
forecast demand for our products and products in development,
including in new market segments; our ability to develop new
technologies, products and markets and to commercialize new
products; our reliance on sales of our COVID-19 and influenza
diagnostic tests; our reliance on a limited number of key
distributors; quantity of our product in our distributors’
inventory or distribution channels; changes in the buying patterns
of our distributors; the financial soundness of our customers and
suppliers; lower than anticipated market penetration of our
products; third-party reimbursement policies and potential cost
constraints; our ability to meet demand for our products;
interruptions, delays or shortages in the supply of raw materials,
components and other products and services; failures in our
information technology and storage systems; our exposure to data
corruption, cyber-based attacks, security breaches and privacy
violations; international risks, including but not limited to,
economic, political and regulatory risks; continuing worldwide
political and social uncertainty; our development, acquisition and
protection of proprietary technology rights; intellectual property
risks, including but not limited to, infringement litigation; the
loss of Emergency Use Authorizations for our COVID-19 products and
failures or delays in receipt of reviews or regulatory approvals,
clearances or authorizations for new products 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, clearances or
authorizations or other adverse actions by regulatory authorities;
our contracts with government entities involve future funding,
compliance and possible sanctions risks; product defects; changes
in government policies and regulations and compliance risks related
thereto; our ability to manage our growth strategy and successfully
identify, acquire and integrate potential acquisition targets or
technologies and our ability to obtain financing; our acquisition
of Alere’s Triage® business presents certain risks to our business
and operations; the level of our deferred payment obligations; 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.; we may need to raise additional funds to finance our
future capital or operating needs; our debt, deferred and
contingent payment obligations; competition for and loss of
management and key personnel; business risks not covered by
insurance; changes in tax rates and exposure to additional tax
liabilities or assessments; and provisions in our charter documents
and Delaware law that might delay or impede stockholder actions
with respect to business combinations or similar transactions.
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, including those discussed in Item 1A, “Risk
Factors” and elsewhere in our Annual Report on Form 10 K for the
year ended December 31, 2020 and in our subsequent Quarterly
Reports on Form 10 Q. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210611005462/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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