Healthcare Industry News: influenza
News Release - February 29, 2008
FDA Grants CLIA Waiver for Quidel's QuickVue(R) RSV TestSAN DIEGO--(HSMN NewsFeed)--Quidel Corporation (NASDAQ:QDEL ), a leading provider of rapid point-of-care (POC) diagnostic tests, announced today that the U.S. Food and Drug Administration (FDA) granted CLIA waiver for the QuickVue® RSV test for the qualitative detection of respiratory syncytial virus (RSV). The waiver makes the QuickVue RSV test more widely available for use, especially in physician offices and clinics where waived tests are used most frequently. The QuickVue RSV test is simple and accurate, with high sensitivity and specificity.
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.1 The QuickVue RSV test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients.
“We are pleased the QuickVue RSV test will now be more widely available for use by physicians, helping to aid clinical diagnosis and guide patient management decisions for some of the most fragile patients of all, infants and young children. With QuickVue tests for some of the most common respiratory ailments including influenza, Strep A, and RSV, Quidel is committed to providing physicians and caregivers with a family of rapid diagnostic tests that have a demonstrated clinical value, a prime example of how our Quidel Value Build (QVB™) strategy continues to help build our customer base,” said Caren Mason, president and CEO of Quidel Corporation.
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.
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.
1 Respiratory Syncytial Virus (RSV). American Academy of Pediatrics, et al., http://www.aap.org/pubed/ZZZSO05MASD.htm?&sub_cat=107 (accessed 1/16/2006)
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