FDA Clears Quidel's Flu, Respiratory Infection Tests
Quidel Corp. said Friday it has received marketing authorization from the U.S. Food and Drug Administration for diagnostic tests for influenza and respiratory infection human metapneumovirus.
The Quidel Molecular Influenza A+B Assay is a molecular diagnostic test for the detection of influenza A and B.
The Quidel Molecular hMPV Assay is the company’s first molecular diagnostic test for human metapneumovirus. The disease affects children by the time they reach five years of age and can cause serious respiratory infections, the company said. The disease affects about 7 percent of children admitted to hospitals with respiratory infections.
The tests are for use with at laboratories with a thermocycler.
Quidel CEO Douglas Bryant said the Santa Clara, Calif.-based company was pleased with the “timely” clearance of the flu product. With regard to the hMPV Assay, he said the company was "pleased with our continued execution of the R&D pipeline."