Quidel Receives CE Mark for Savanna® Multiplex Molecular Analyzer and Respiratory Viral Panel
July 12 2021 - 9:15AM
Business Wire
New Savanna® platform can analyze up to 12
pathogens, plus controls, from a single sample
Savanna® RVP4 Assay targets influenza A+B, RSV
and COVID-19
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading
provider of rapid diagnostic testing solutions, cellular-based
virology assays and molecular diagnostic systems, announced today
that the company has received the CE Mark for its innovative
Savanna® multiplex molecular analyzer and Savanna® RVP4 Assay
(Respiratory Viral Panel-4). The CE Mark allows Quidel to market
and sell the Savanna system in Europe, as well as other countries
that accept the CE Mark.
Savanna is Quidel’s revolutionary multiplex molecular platform
that enables professional customers to analyze up to 12 pathogens
or targets, plus controls, from a single assay run in less than 30
minutes. The Savanna system is a fully integrated, sample-to-result
automated in-vitro diagnostic platform that performs real-time
Polymerization Chain Reaction (PCR) tests by using the Savanna
instrument and Savanna assay cartridges. After inserting the assay
cartridge, the instrument performs sample and reagent preparation,
nucleic acid extraction and amplification, real-time detection of
RNA or DNA target sequence, and qualitative or quantitative result
interpretation from a variety of sample types. The Savanna system
is intended to aid in the diagnosis of the related diseases.
Quidel’s initial Savanna RVP4 Assay (Respiratory Viral Panel-4)
is a rapid, multiplexed nucleic acid test intended for use with the
Savanna instrument for the simultaneous qualitative detection and
differentiation of influenza A (Flu A), influenza B (Flu B),
respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from
human nasal or nasopharyngeal swabs in media obtained from patients
with signs and symptoms of respiratory tract infection. This in
vitro diagnostic test is intended to aid in the differential
diagnosis of infections with these viruses. The Savanna RVP4 Assay
comes in a fully integrated cartridge that is stable at room
temperature.
“Receipt of the CE Mark is an important step forward on our path
to commercialize Savanna’s powerful but simple-to-use molecular
diagnostic technology,” said Douglas Bryant, president and CEO of
Quidel Corporation. “The Savanna system’s small footprint features
integrated sample prep combined with rapid real-time PCR
amplification and detection technologies, making it a perfect fit
for syndromic testing in hospitals and moderate-complexity labs,
with the goal of eventually accessing physician offices, urgent
care clinics and other point-of-care locations. We expect to deploy
our first batch of instruments to select international customers
and the performance data generated will support our longer-term
commercialization efforts as we build instrument inventory that we
anticipate will be required for our planned broad-scale launch in
the U.S.”
About the CE Mark
The Conformitè Europëenne (CE) Mark is defined as the European
Union’s (EU) mandatory conformity marking for regulating the goods
sold within the European Economic Area (EEA) since 1985. The CE
marking represents a manufacturer’s declaration that products
comply with the EU’s New Approach Directives. These directives not
only apply to products within the EU but also for products that are
manufactured in or designed to be sold in the EEA. This makes the
CE marking recognizable worldwide even to those unfamiliar with the
EEA.
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/20210712005132/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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