Diagnostic Hybrids, a Quidel Company (NASDAQ: QDEL) has received
emergency use authorization from the U.S. Food and Drug Administration
(FDA) for its D3®
UltraTM 2009 H1N1
Influenza A Virus ID Kit, a monoclonal antibody fluorescent staining kit
for the specific identification of 2009 H1N1 influenza A in direct
patient specimens or incubated tissue cultures. The
D3
Ultra 2009 H1N1 Influenza A Virus ID Kit is to
be used for individuals with signs and symptoms of influenza and who
previously tested positive for the presence of influenza A
virus-infected cells by a currently available FDA-cleared direct
immunofluorescence influenza A antibody device such as the D3
Ultra
Respiratory Virus Screening and ID Kit. Emergency use authorization
allows for the early availability of important diagnostic and
therapeutic tools "to diagnose, treat, or prevent serious or
life-threatening diseases or conditions […] when there are no adequate,
approved and available alternatives.”1
"During the ongoing influenza surveillance, it is important for us to
provide laboratories with the best possible influenza testing
solutions,” said Steve Ewers, senior product manager at Diagnostic
Hybrids. "Currently available tests are all based on the detection of
2009 H1N1 nucleic acid. This technology is not available in all
laboratories due to its equipment expense and complexity. The D3
Ultra 2009 H1N1 ID Kit gives these laboratories the opportunity
to identify 2009 H1N1 influenza A virus using the immunofluorescent
methodologies without any added equipment or training.”
"The FDA’s emergency use authorization of Diagnostic Hybrids’ H1N1
Influenza A Virus ID kit will allow access to a monoclonal antibody
product with great potential for expediting patient care in a time when
fast, accurate diagnosis of 2009 H1N1 infection is critical,” said David
R. Scholl, Ph.D., senior vice president, commercial operations &
president of Diagnostic Hybrids. "As we enter the main part of flu
season in North America, we are proud to provide large and small
laboratories alike with a cost-effective method for the detection of
2009 H1N1 infections.”
The D3
Ultra H1N1 ID Kit is the first indirect
fluorescent assay available on the market that specifically identifies
the 2009 H1N1 influenza A virus from nasopharyngeal swabs, aspirates and
washes. It complements the company’s other respiratory testing
technologies, which can detect the H1N1 virus as influenza A positive,
but do not specifically identify the 2009 H1N1 influenza virus subtype.
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people
around the globe through the development of rapid diagnostic solutions
that can lead to improved patient outcomes and provide economic benefits
to healthcare providers. Marketed under the leading brand names
QuickVue®, D3 Direct Detection™ and Thyretain™, Quidel’s
products aid in the detection and diagnosis of many critical diseases
and conditions, including influenza,
respiratory
syncytial virus, Strep A, herpes, pregnancy, thyroid
disease and fecal
occult blood. Quidel’s research and development engine, including
its Specialty Products Group, 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 www.quidel.com
and Diagnostic Hybrids at www.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
our strategic initiatives, uncertainty surrounding the detection of
novel influenza viruses involving human specimens, adverse changes in
the competitive and economic conditions in domestic and international
markets, actions of our major distributors, technological changes and
uncertainty with research and technology development, including any
future molecular-based technology, the 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, intellectual property, product
liability, environmental or other litigation, potential required patent
license fee payments not currently reflected in our costs, potential
inadequacy of booked reserves and possible impairment of goodwill, and
lower-than-anticipated sales or market penetration of our new products.
Further, with respect to the acquisition of Diagnostic Hybrids, Inc. and
related statements, these statements are based on our current
expectations as to future events, but are subject to numerous risks and
uncertainties. These risks and uncertainties include the potential that
Diagnostic Hybrids’ growth will not follow historical patterns and the
possibility that integration of the two companies will not be as
successful as we expect. Quidel can give no assurance that future
results will be as expected. 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 Emergency Use Authorization of Medical Products, U.S. Food
& Drug Administration, http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm
