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Roche H1N1 flu test wins emergency clearance

This article was originally published in The Gray Sheet

Executive Summary

FDA grants emergency use authorization to Roche's RealTime Ready Influenza A/H1N1 Detection Set,which will allow clinicians to test for the presence of the 2009 H1N1 influenza virus collected via nasopharyngeal swabs, nasal swabs, washes and aspirates in clinical settings, and "augment existing testing capacity" for the H1N1 virus, FDA says in its Nov. 13 EUA letter. FDA has also granted emergency use authorization for use of Roche's Detection Set on the company's LightCycler 2.0 ("1The Gray Sheet" Aug. 24, 2009)

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