20.05.2008 12:00:00
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Quidel and Prodesse Announce Flu and RSV Molecular Partnership
Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid
point-of-care (POC) diagnostic tests, and Prodesse, Inc., a
biotechnology company focused on developing molecular diagnostic
reagents for a variety of infectious diseases, announced today an
agreement between the two companies to jointly promote Prodesse’s
ProFlu+™ multiplex molecular diagnostic test
within the United States. ProFlu+ is an FDA 510(k) cleared, real-time
PCR, closed tube test that simultaneously detects Influenza A, Influenza
B and respiratory syncytial virus (RSV), which together cause the vast
majority of serious respiratory infections.
The agreement strengthens Prodesse’s own sales
efforts with acute care representation by the Quidel sales and marketing
teams. Caren Mason, president and CEO of Quidel, commented, "Our
acute care customers look for leadership from Quidel in influenza
management. By co-promoting this product, we are providing an
alternative solution to those seeking a molecular complement to their
rapid testing program.” Tom Shannon, president
and CEO of Prodesse, remarked, "Our
partnership with Quidel will aid us in expanding our reach to the
thousands of hospitals that utilize the many instruments that are
capable of running ProFlu+.”
Quidel will now have access to a new molecular product, particularly
suited for the acute care laboratory market. The ProFlu+ test provides a
complementary product offering to the Quidel QuickVue®
rapid influenza and RSV tests. As part of the agreement, Quidel earns a
fee for all product placements.
According to the Centers for Disease Control (CDC), influenza is
responsible for about 36,000 deaths and more than 200,000
hospitalizations in the U.S. each year1. The
National Foundation of Infectious Diseases, in a report released in
September 2007, indicates that influenza can be especially severe for
those with high-risk conditions (e.g., diabetes and heart disease), and
recent studies have also found that the illness may trigger up to 92,000
cardiac deaths per year nationwide2. The
QuickVue Influenza A+B test is intended for use as an aid in the rapid
differential diagnosis of acute influenza type A and B.
Respiratory syncytial virus is recognized by the American Academy of
Pediatrics as the leading cause of pneumonia and bronchiolitis among
children two years of age and younger. RSV is a common virus with
symptoms that often resemble the common cold3.
The QuickVue RSV test is intended for use as an aid in the diagnosis of
acute RSV viral infections for symptomatic pediatric patients.
1 CDC, Page last updated November 16, 2007;
Content Source: Coordinating Center for Infectious Diseases (CCID) National
Center for Immunization and Respiratory Diseases (NCIRD).
2 National Foundation for Infectious Diseases,
September 20, 2007.
3 Respiratory Syncytial Virus (RSV). American
Academy of Pediatrics, et al., http://www.aap.org/pubed/ZZZSO05MASD.htm?&sub_cat=107
(accessed 1/16/2006).
About Quidel Corporation
Quidel Corporation serves to enhance the health and well being of people
around the globe through the discovery, development, manufacturing and
marketing of rapid diagnostic solutions at the point of care (POC) in
infectious diseases and reproductive health. Marketed under the leading
brand name of QuickVue®,
Quidel’s portfolio of products currently
includes tests that aid in the diagnosis of several disease or condition
states, including influenza, respiratory syncytial virus, Fecal Occult
Blood, Strep A, pregnancy, bacterial vaginosis, H. pylori and Chlamydia.
Quidel's products are sold to healthcare professionals with a focus on
the physician office lab and acute care markets through leading medical
distribution partners on a worldwide basis. Quidel's Specialty Products
Group (SPG) develops research products in the fields of oncology and
bone health with potential future point-of-care applications. By
building value in rapid diagnostic tests, Quidel provides leadership to
the industry and among healthcare professionals allowing for the
movement of patient testing out of the central laboratory setting and
into the physician office, urgent care and other outpatient settings
where rapid testing and treatment has an impact on clinical outcomes and
provides an economic benefit. For more information, visit www.quidel.com,
www.colorectal-test.com or www.flutest.com.
About Prodesse, Inc.
Prodesse is a biotechnology company focused on developing molecular
diagnostic reagents for a variety of infectious disease applications.
The company’s products are designed based on
a combination of Prodesse’s patented
technologies and other licensed technologies. Prodesse sells FDA 510(k)
cleared products worldwide, CE Marked in vitro diagnostic kits outside
the U.S. and research use only kits worldwide. The company’s
products can be used on multiple nucleic acid extraction and real-time
PCR platforms. Prodesse also operates a CLIA certified laboratory for
testing services in the Midwest area. For more information about
Prodesse and its products, call 888-589-6974 or go to www.prodesse.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. 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 length and severity of
cold and flu seasons, 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 (the "FDA”),
intellectual property, product liability, environmental or other
litigation, 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. 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.
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