Quidel's flu test receives FDA clearance for new claims

By Angela McDaniels

Seattle, Dec. 29 - Quidel Corp. said it has gained permission from the Food and Drug Administration to include additional claims on the package insert for the QuickVue Influenza A+B 10-minute diagnostic test.

The package insert is being updated to include clinical study results for nasal swab, nasopharyngeal swab and nasal wash tests and analytical study results for the detection of cultured avian influenza viruses.

News claims include the test's ability to detect avian influenza viruses, including avian influenza A subtype H5N1 virus, and the test's 94% sensitivity for detecting influenza A when using nasal swab specimens.

"Calendar year 2005 has been a strong, foundational year for Quidel," president and chief executive officer Caren Mason said in a company news release.

"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."

Quidel develops diagnostic tests and is based in San Diego.

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