SAN DIEGO--(BUSINESS WIRE)--Jun. 28, 2017--
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic
testing solutions, cellular-based virology assays and molecular
diagnostic systems, announced today it has received 510(k) clearance and
Clinical Laboratory Improvements Amendments (CLIA) waiver from the
United States Food and Drug Administration (FDA) for Quidel’s Sofia RSV
Fluorescent Immunoassay (FIA) to be used with the Sofia 2 Fluorescent
Immunoassay Analyzer for the rapid detection of respiratory syncytial
virus (RSV) infections in nasopharyngeal swab and nasopharyngeal
aspirate/wash specimens taken directly from symptomatic pediatric
patients.
Sofia 2 is Quidel’s next-generation version of its best-selling Sofia
instrumented system. Sofia 2 utilizes the original Sofia’s fluorescent
chemistry design while improving upon the graphical user interface and
optics system to provide an accurate, automated and objective result in
as few as 3 minutes. Sofia 2 also integrates wireless connectivity and
its barcode scanner within a smaller footprint than the legacy Sofia
instrument.
The next-generation Sofia system also comes connected to Virena®,
Quidel’s data management system, which provides aggregated,
de-identified testing data in near real-time.
The Sofia RSV assay employs advanced lateral flow and immunofluorescence
technologies to provide enhanced clinical sensitivity for RSV, one of
the most serious respiratory diseases in children and seniors. These
technologies help ensure a reliable, objective, rapid, and accurate
diagnostic result. The Centers for Disease Control and Prevention (CDC)
estimate that Respiratory Syncytial Virus, or RSV, leads to 2.1 million
annual outpatient visits among children younger than 5 years old, and
that 25% - 40% of young children infected with RSV for the first time
will exhibit signs of pneumonia or bronchiolitis.1,2
In addition to the several thousand hospitals, medical centers and
smaller clinics in the United States, the receipt of CLIA waiver
markedly expands the available market for the Sofia 2 test system.
“With the clearance of Sofia Influenza A+B and Sofia RSV on the new
Sofia 2 instrument, we are now able to diagnose two of the most common
respiratory diseases more quickly, more easily and at a lower cost; a
perfect fit for the specific needs of the point-of-care space,” said
Douglas Bryant, president and chief executive officer of Quidel
Corporation. “We see Sofia 2 building on the success of our original
Sofia flagship product by expanding our instrument placements into the
smaller, lower volume physician offices as well as the higher volume
health systems, while also significantly growing our Virena wireless
coverage throughout the country.”
Sofia 2 received CLIA waiver for the Sofia Influenza A+B assay from the
FDA in May, and is now available for sale in the U.S.
1. https://www.cdc.gov/rsv/research/us-surveillance.html
2.
https://www.cdc.gov/rsv/clinical/index.html
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® 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, herpes, pregnancy, thyroid
disease and fecal
occult blood. Quidel's research and development engine is also
developing a continuum of diagnostic solutions from advanced
lateral-flow and direct fluorescent antibody 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, visit quidel.com.
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, fluctuations in our operating results
resulting from seasonality, the timing of the onset, length and severity
of cold and flu seasons, government and media attention focused on
influenza and the related potential impact on humans from novel
influenza viruses, adverse changes in competitive conditions in domestic
and international markets, changes in sales levels as it relates to the
absorption of our fixed costs, lower than anticipated market penetration
of our products, the reimbursement system currently in place and future
changes to that system, changes in economic conditions in our domestic
and international markets, 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
intellectual property; our development of new technologies, products and
markets; our reliance on a limited number of key distributors; our
reliance on sales of our influenza diagnostics tests; our ability to
manage our growth strategy, including our ability to integrate companies
or technologies we have acquired or may acquire; intellectual property
risks, including but not limited to, infringement litigation; our debt
service requirements; our inability to settle conversions of our
Convertible Senior Notes in cash; the effect on our operating results
from the trigger of the conditional conversion feature of our
Convertible Senior Notes; the possibility that we may incur additional
indebtedness; our need for additional funds to finance our operating
needs; volatility and disruption in the global capital and credit
markets; 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”); changes in government policies; compliance with other
government regulations, such as safe working conditions, manufacturing
practices, environmental protection, fire hazard and disposal of
hazardous substances; third-party reimbursement policies; our ability to
meet demand for our products; interruptions in our supply of raw
materials; product defects; business risks not covered by insurance and
exposure to other litigation claims; interruption to our computer
systems; competition for and loss of management and key personnel;
international risks, including but not limited to, compliance with
product registration requirements, 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, taxes, and
diversion of lower priced international products into U.S. markets;
dilution resulting from future sales of our equity; volatility in our
stock price; provisions in our charter documents, Delaware law and 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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Source: Quidel Corporation
Quidel Contact:
Quidel Corporation
Randy Steward
Chief
Financial Officer
(858) 552-7931
or
Media and Investors
Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
rargueta@quidel.com