Quidel Receives FDA Clearance & CLIA Waiver for Its Point-of-Care Sofia® 2 Immunoassay Analyzer for Use with Sofia Influenza...
May 30 2017 - 1:15PM
Business Wire
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 Influenza A+B Fluorescent Immunoassay
(FIA) to be used with the Sofia 2 Fluorescent Immunoassay Analyzer
for the rapid, differential detection of Influenza types A and B
from direct nasal swab, nasopharyngeal swab, and nasopharyngeal
aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal
aspirate/wash specimens in transport media from symptomatic
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 Sofia Influenza A+B assay employs advanced lateral flow and
immunofluorescence technologies to provide enhanced clinical
sensitivity for Influenza A or B infections. These features help
ensure a reliable, objective, rapid, and accurate diagnostic
result. The Centers for Disease Control and Prevention (CDC)
estimates that flu-related hospitalizations in the United States
range from a low of 140,000 (during 2011-2012) to a high of 710,000
(during 2014-2015)1.
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.
“The Sofia 2 instrument is completely compatible with existing
Sofia test cartridges, has a modern graphical user interface, is
portable and small enough for exam rooms, can be connected to our
cloud, and has an integrated barcode scanner. From our perspective,
Sofia 2’s much lower manufacturing cost is an important benefit, as
it will allow us to place instruments in an increased number of
settings and to expand our reach,” said Douglas Bryant, president
and chief executive officer of Quidel Corporation. "From the
customer’s perspective, we believe that the biggest benefit for
Sofia 2 users will be its ability to report a positive test result
in as little as three minutes, which will be a significant help in
managing patient workflow. Sofia 2 is expected to be an important
product for us moving forward as it has a number of features that
will be beneficial to an even larger set of existing and new
customers."
1. https://www.cdc.gov/flu/about/qa/hospital.htm
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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version on businesswire.com: http://www.businesswire.com/news/home/20170530006124/en/
Quidel Contact:Quidel CorporationRandy StewardChief Financial
Officer(858) 552-7931orMedia and Investors Contact:Quidel
CorporationRuben Argueta(858) 646-8023rargueta@quidel.com
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