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Quidel Corporation Elaborates upon Flu Test Claims, Including Data for All Specimen Types
SAN DIEGO--(BUSINESS WIRE)--Jan. 6, 2006--Quidel Corporation (Nasdaq:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, today released additional package insert data to support its new flu test claims in light of significant interest since the Company's announcement regarding FDA clearance on December 29, 2005.
The QuickVue(R) Influenza A+B test allows for the rapid, qualitative detection of Influenza Type A and Type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash and/or nasal aspirate specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute Influenza Type A and Type B viral infections. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use. The Company's original clinical study in 1998/1999 showed sensitivity (true positive identification) of 72% for Influenza Type A with nasal swabs vs. culture and specificity (true negative identification) of 96%. The most recent clinical study in 2005 showed sensitivity of 94% for Influenza Type A with nasal swabs vs. culture and specificity of 90%. Influenza Type A is the prevalent strain of Influenza.(1) The original clinical study in 1998/1999 showed sensitivity of 73% for Influenza Type B with nasal swabs vs. culture and specificity of 96%. The 2005 clinical study showed sensitivity of 74% for Influenza Type B with nasal swabs vs. culture and specificity of 97%.
The Company's new claims without past clinical study results include those for nasopharyngeal swab specimens for Influenza Type A and Influenza Type B vs. culture and results for Influenza Type A with frozen nasal wash vs. culture. Nasopharyngeal swab specimens vs. culture for Influenza Type A showed 83% sensitivity and 89% specificity. Nasopharyngeal swab specimens vs. culture for Influenza Type B showed 67% sensitivity vs. culture and 98% specificity vs. culture. Frozen nasal wash results versus culture for Influenza Type A showed 86% sensitivity and 95% specificity. As previously indicated, the package insert for the test is being updated to include complete clinical study results for nasal swab, nasopharyngeal swab and nasal wash in addition to analytical study results for the detection of cultured avian Influenza viruses. The performance of any rapid flu test is dependent on the sample type, the quality of sample collection, the care taken in sample handling, the stage of the patient's infection, the prevalence of disease in the region, and among other things, the adherence to the test's package insert. Each of these factors can impact actual clinical performance and outcome.
The Company's website, www.quidel.com, and its Influenza website, www.flutest.com, are being updated to include the new package insert, ease of use, speed to result and comparative claims data. Flu prevalence data from the Centers for Disease Control and Prevention ("CDC") is updated weekly and can be accessed through the www.flutest.com website. Currently, the CDC reports that Influenza activity in the United States is increasing, with visits to the sentinel providers (reporting physicians) above the national baseline.
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, 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 potential point-of-care applications in the future. 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 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 H5N1 involving human specimens, 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.
(1) Murphy, B.R., and R.G. Webster, 1996, Orthomyxoviruses, pp. 1397-1445. In: Fields Virology, 3rd edition, B.N. Fields, D. M. Knipe, P.M. Howleym et al. (eds.), Lippincott-Raven, Philadelphia.
CONTACT: Company Contact:
Paul E. Landers, 858-552-7962
Lippert/Heilshorn & Associates
Bruce Voss or Don Markley, 310-691-7100
SOURCE: Quidel Corporation