Quidel's Flu Test Receives FDA Clearance For New Claims

San Diego - Quidel Corporation, a provider of rapid point-of-care (POC) diagnostic tests, reported that it has obtained FDA clearance for its new and improved claims for the QuickVue Influenza A+B test which is a 10-minute diagnostic test for influenza. Among new claims added to the package insert is 94% sensitivity for detecting Influenza A when using nasal swab specimens. The package insert for the test is being updated to include 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 QuickVue Influenza A+B test has been shown to detect cultured avian influenza viruses, including avian Influenza A subtype H5N1 virus; however, as with other rapid tests for influenza, the ability of the QuickVue Influenza A+B test to detect influenza A in patients infected with H5N1 has not been established.

A clinical study to validate the performance of Quidel's 10-minute diagnostic test for influenza, the QuickVue Influenza A+B test, was completed in Australia during that continent's flu season from July through September 2005. The clinical data reinforce the analytical study findings from the University of Rochester Medical Center, announced on May 10, 2005, which demonstrated that the Quidel test had the highest sensitivity, 95% of the time, was the easiest to use and provided the most rapid time to result compared with competing rapid tests. Currently, the Centers for Disease Control and Prevention reports that influenza activity in the United States is increasing with visits to the sentinel providers (reporting physicians) above the national baseline.

Caren Mason, the Company's President and CEO, commented, "Calendar year 2005 has been a strong, foundational year for Quidel. We have seen market share gains over prior year in key product segments, strong demand for seasonal and non-seasonal tests throughout the year, a number of new products in preparation for market launch, and a strong projected finish in revenue and earnings. The Company is executing on all cylinders by achieving its strategic imperatives and operational commitments. The financial picture for Quidel is one of ever increasing strength and profitability."

SOURCE: Quidel Corp.