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SAN DIEGO, CA, Mar 27, 2012 (MARKETWIRE via COMTEX)
--Quidel Corporation (NASDAQ: QDEL), announced today that
it received CE mark for the AmpliVue C. difficile assay,
its non-instrumented molecular test for the detection of
toxigenic Clostridium difficile bacterial DNA. Detection
of the pathogen is achieved using a hand-held fully
contained detection cassette which utilizes lateral flow
technology. C. difficile is frequently associated with
antibiotic therapy and often causes diarrhea and
inflammation of the colon.
"Clostridium difficile infections can be
life-threatening and are therefore critically important
to diagnose as soon as possible. Molecular testing
offers greater sensitivity and faster turn-around-times
compared to many other methods," according to Dr.
Timothy Stenzel, M.D., Ph.D., chief scientific officer
of Quidel.
A recent study published in the Lancet(1)
suggests that a majority of the hospital-based labs in
Europe continue to use traditional methods such as
immunoassays or cytotoxicity assays. These assays may
either lack sufficient sensitivity or are difficult to
perform and may require several days to yield results.
The AmpliVue C. difficile assay will allow these labs
to quickly implement a fast and sensitive molecular
method without the purchase of expensive capital
equipment.
"We are delighted to receive CE mark for our
AmpliVue C. difficile assay," said Douglas Bryant,
president and chief executive officer of Quidel
Corporation. "The AmpliVue C. difficile assay will
allow those labs that have previously opted for
traditional methods to offer a more sensitive molecular
test for patients in their care."
The C. difficile assay is Quidel's first
assay in the hand-held AmpliVue format, and is
currently available for sale in Europe. Quidel also
sells other CE Marked molecular tests in the Real-Time
PCR format for Influenza A+B, hMPV, and RSV +
hMPV.
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 QuickVue(R), D3(R) Direct Detection
and Thyretain(TM) leading brand names, as well as under
the new Sofia(R) and Quidel Molecular(TM) 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 and
Diagnostic Hybrids at dhiusa.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, seasonality, the timing of onset, length
and severity of cold and flu seasons, the level of
success in executing on our strategic initiatives, our
reliance on sales of our influenza diagnostic tests,
uncertainty surrounding the detection of novel
influenza viruses involving human specimens, our
ability to develop new products and technology, adverse
changes in the competitive and economic conditions in
domestic and international markets, our reliance on and
actions of our major distributors, technological
changes and uncertainty with research and technology
development, including any molecular-based technology,
the medical reimbursement system currently in place and
future changes to that system, manufacturing and
production delays or difficulties, adverse actions or
delays in product reviews by the U.S. Food and Drug
Administration (the "FDA"), our ability to
comply with FDA, environmental and other regulations,
our ability to meet unexpected increases in demand for
our products, our ability to execute our strategy,
including the integration of new companies or
technologies, disruptions in the global capital and
credit markets, our ability to hire key personnel,
intellectual property, product liability, environmental
or other litigation, potential required patent license
fee payments not currently reflected in our costs,
adverse changes in our international markets, potential
inadequacy of booked reserves and possible impairment
of goodwill, and lower-than-anticipated acceptance,
sales or market penetration of our new products.
Forward-looking statements typically are identified by
the use of terms such as "may,"
"will," "should,"
"might," "expect,"
"anticipate," "estimate," and
similar words, although some forward-looking statements
are expressed differently. The risks described under
"Risk Factors" in reports and registration
statements that we file with 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. We undertake
no obligation to publicly release the results of any
revision or update of the forward-looking statements,
except as required by law.
(1) Clostridium difficile infection in Europe: a
hospital-based survey, Lancet 2011; 377: 63-73.
Quidel Contact:
Quidel Corporation
Randy Steward
Chief Financial Officer
(858) 552-7931
Media and Investors Contact:
Quidel Corporation
Ruben Argueta
(858) 646-8023
Email Contact
SOURCE: Quidel
http://www2.marketwire.com/mw/emailprcntct?id=916F95F3D1A1D663
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