SAN DIEGO--(BUSINESS WIRE)--May 24, 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 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.
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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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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