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|Study Validates Higher Sensitivity of Quidel's QuickVue Influenza A+B Test among Rapid Flu Tests; University of Rochester Presents Research at Clinical Virology Symposium|
SAN DIEGO--(BUSINESS WIRE)--May 10, 2005--Quidel Corporation (Nasdaq:QDEL), a leading provider of rapid point-of-care diagnostic tests, received third-party validation of its QuickVue(R) Influenza A+B test in a study(1) presented at the 21st Annual Clinical Virology Symposium and Annual Meeting of the Pan American Society for Clinical Virology. The study, conducted by scientists at the University of Rochester Medical Center, found that the QuickVue(R) Influenza A+B assay demonstrated the highest analytical sensitivity among the four tests examined for their effectiveness in detecting the flu.
In quoting the abstract from the study: "A number of rapid immunoassays for influenza are now available to both clinicians and clinical microbiologists. However, it is difficult to derive a clear understanding of the comparative performance of these devices from published evaluations using clinical specimens because the relative amount of antigen is undefined in these specimens. The purpose of this study was to compare the performance of 4 Influenza A+B assays under controlled conditions."
Melinda Nye, PhD and clinical microbiology fellow at the University of Rochester Medical Center, led the sensitivity study comparing the QuickVue(R) Influenza A+B test's performance to three other currently available, point-of-care influenza diagnostics. The research was conducted under controlled laboratory conditions and results showed that the QuickVue(R) Influenza A+B test was more sensitive than the other tests 95 percent of the time.
"The objective of our study was to give clinicians a clear understanding of the comparative performance of rapid influenza tests currently available," Nye said. "After a thorough evaluation, the QuickVue(R) Influenza A+B test clearly outperformed in terms of analytical sensitivity, ease of use and rapid time to result. Although we might predict a more analytically sensitive test to be more sensitive with patient specimens, these studies need to be done separately."
"This study further validates what the market is telling us -- that Quidel's QuickVue(R) brand consistently outranks competitors in the important categories of sensitivity and ease of use," said Caren Mason, President and CEO of Quidel. "With the growing concern that an influenza pandemic could be on the horizon, it is essential for the clinical community to have a rapid test that will allow them to quickly identify patients infected with influenza viruses in order to help control the spread of infection. Knowing which test has the highest sensitivity arms the clinical and public health communities with the information they need to make the best choice of test."
QuickVue(R) is the leading brand of rapid influenza tests(1). More than 60% of U.S. physicians who test for influenza use the QuickVue(R) brand(1). For more information about the QuickVue(R) Influenza tests, please go to: www.quidel.com.
(1) The study was supported by Surveillance Data Inc. and funded by Quidel Corporation as a part of its new Quidel Value Build (QVB) assurance protocol, designed to provide proof to clinicians that point of care tests demonstrate improved patient outcomes.
(2) Source: Healthcare Products Information Services (HPIS) Q4 2004 data.
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), the portfolio currently includes tests that aid in the diagnosis of several disease or condition states, including influenza, Strep A, pregnancy, bacterial vaginosis, infectious mononucleosis, 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 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.
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risk 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 operating results may arise as a result of a number of factors including, without limitation, seasonality, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration ("FDA"), intellectual property, product liability, environmental or other litigation, and the lower acceptance of our new products than forecast. 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 of the forward-looking statements.