Quidel Receives PMDA Approval for Its Point-of-Care Sofia® Influenza A+B Assay
May 24 2017 - 6:30PM
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
approval from Japan’s Pharmaceuticals and Medical Devices Agency
(PMDA) for Quidel’s Sofia® Influenza A+B Fluorescent Immunoassay
(FIA) to be used with the Sofia® Fluorescent Immunoassay
Analyzer.
Sofia is the brand name for Quidel’s instrumented immunoassay
system. The easy-to-use Sofia Analyzer and Sofia Influenza A+B FIA
combine unique software and fluorescent chemistry to yield an
automatic, objective result that is readily available on the
instrument’s screen, in a hard-copy printout, and in a
transmissible electronic form that can network via an LIS system to
hospital and medical center databases.
The Sofia FIA employs advanced lateral flow and
immunofluorescence technologies to provide enhanced clinical
sensitivity for influenza A and B. The Sofia Analyzer provides for
high-throughput batching methods, and other features designed to
facilitate use in a variety of healthcare settings, including
hospitals, medical centers, small clinics and doctors’ offices.
These features help ensure a reliable, objective, rapid, and
accurate diagnostic result.
It is estimated that there were between 13 million to 16 million
confirmed cases of Influenza in Japan every year between 2010 and
2014.1
“We are pleased to have received approval in Japan for our Sofia
Influenza A+B assay, and are excited about the opportunity to
expand Sofia’s international footprint,” said Douglas Bryant,
president and chief executive officer of Quidel Corporation.
The Sofia® Fluorescent Immunoassay Analyzer, Sofia® Group A
Strep Assay, and Sofia® RSV assay are also currently available for
sale in Japan.
_____________________________________________________________________________________
1.
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0146520
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,
our reliance on development of new technologies, 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 the related
potential impact on humans from novel influenza viruses, adverse
changes in competitive conditions in domestic and international
markets, 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, 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 proprietary technology rights; 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
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; 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; 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 the indenture covering 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/20170524006311/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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