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Study Validates Sensitivity of Quidel Rapid Test to Detect Bacterial Vaginosis; Condition Accounts for over 10 Million Physician Office Visits in the U.S. Annually
SAN DIEGO--(BUSINESS WIRE)--Aug. 12, 2005--Quidel Corporation (Nasdaq:QDEL), in conjunction with key researchers in the U.S. and Canada, announces the completion of a clinical study that proves the proprietary layered thin film (LTF(TM)) QuickVue(R) Advance pH and Amines rapid test achieves a clinical sensitivity of 92 percent, specificity of 95 percent and overall accuracy of 94 percent when compared to traditional, more time consuming and more technically demanding procedures such as Amsel clinical criteria and Gram Stain for the diagnosis of bacterial vaginosis (BV). Undiagnosed or untreated bacterial vaginosis may be a risk factor for pelvic inflammatory disease (PID), complications of pregnancy and increased risk of sexually transmitted diseases, including HIV. The QuickVue(R) Advance test provides physicians with an easy-to-use, reliable and fast test which produces results in one minute after sample application and takes only 30 seconds hands-on time to perform. The test is ideal for use in the physician's office where most of the approximately 10 million office visits take place annually in the U.S. as women seek help for symptoms associated with infectious vaginitis.
Dr. Aulena Chaudhuri, a senior scientist at Quidel, recently presented the study results in a poster presentation at the 2005 Annual Meeting of the International Congress of Clinical Chemistry in Orlando, Florida. Among Reproductive Health specialists participating in the study were David Soper, M.D., Medical University of South Carolina and Jane Schwebke, M.D., University of Alabama at Birmingham, both renowned experts in the field of reproductive infectious disease. Dr. Schwebke, one of the principal investigators, stated, "There is a pressing need for rapid tests that are simple, accurate, and easy-to-use for diagnosis of bacterial vaginosis. This is a disease that is on the rise in the United States and there is a need to educate physicians more about the consequences of this disease and to provide them a more convenient means to make its diagnosis. Quidel's test is a major step in the right direction."
Caren Mason, president and CEO of Quidel Corporation, commented, "This study is another example of Quidel's dedication to conducting clinical proof studies which fulfill our commitment to demonstrate product effectiveness while supporting the increasing trend toward evidence-based medicine... we have branded this commitment QVB(TM), the Quidel Value Build."
About Quidel Corp.
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, 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.
Cathy Diramio, 310-577-7870 x129
SOURCE: Quidel Corporation