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|Quidel and Prodesse Announce Flu and RSV Molecular Partnership|
SAN DIEGO--(BUSINESS WIRE)--May 20, 2008--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+(TM) 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(R) 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 year(1). 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 nationwide(2). 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 cold(3). 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(R), 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.